Protalix BioTherapeutics Overview
Protalix BioTherapeutics is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant-cell-based protein expression system. The company's pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets. Protalix gained FDA approval for a plant-cell culture-expressed protein. Elelyso (taliglucerase alfa for injection) is the company's first drug product produced by ProCellEx. Elelyso was approved for marketing by the FDA in May 2012, soon followed by approval from multiple regulatory agencies including the EMA, Australian TGA, Brazilian ANVISA, and the Israeli Ministry of Health. The product has been licensed to Pfizer. The Protalix ProCellEx platform has the ability to manufacture complex proteins, antibodies, and vaccines and to orally deliver certain therapeutic proteins as demonstrated in animal models.
Cumulative Funding Raised Over Time ($)
$5.3MDec 2005
$49.0MMar 2020
$52.5MOct 2004
$62.5MOct 2015
Latest News
growth-negative
3 Compelling Penny Stocks With Market Caps Under $600M
Organogenesis Holdings Inc., a company in the regenerative medicine sector, is facing challenges typical for its industry. Despite setbacks in Phase 3 trials for its product ReNu, the product maintains a favorable safety profile and holds a Regenerative Medicine Advanced Therapy designation from the FDA. The company, with a market cap of $540.41 million, remains unprofitable but has improved its net loss and forecasts revenue growth up to $510 million by the end of 2025. Organogenesis operates debt-free but faces cash runway constraints if free cash flow grows at historical rates.
Product StageFDA approved/pending approval
growth-negative
Can Protalix (PLX) Turn Regulatory Setbacks Into a Competitive Advantage in Rare Disease Markets?
The European Medicines Agency (EMA) issued a negative opinion on Protalix BioTherapeutics and Chiesi Groups request for a less frequent dosing schedule for Elfabrio in Fabry disease, citing insufficient data. This regulatory setback highlights challenges in modifying dosing regimens to reduce patient treatment burdens. Despite this, the FDAs approval of Elfabrio in May 2025 underscores its commercial potential, with ongoing efforts for label expansion. The EMAs decision raises questions about short-term revenue growth but does not affect the initial FDA approval in the US. Protalix is projected to reach significant revenue and earnings growth by 2028, with a fair value estimate suggesting a substantial upside to its current stock price.
FDA approvedProduct StagePartners
growth-negative
Protalix BioTherapeutics (PLX): Evaluating Valuation After EMA Setback on Elfabrio Dosing Regimen
Protalix BioTherapeutics experienced a significant drop in share price following a negative opinion from the European Medicines Agency (EMA) regarding a proposed dosing schedule for its Fabry disease therapy, Elfabrio. The companys stock fell by 22.5% in a single day, erasing recent gains. Despite this setback, Protalix has shown a 1-year total shareholder return of over 70%. The market is currently debating whether the company is undervalued, with shares trading below analyst targets. The companys future growth prospects are influenced by ongoing regulatory challenges and geopolitical instability. Protalix has no debt and potential lucrative therapies in its pipeline, which could drive future growth if approved.
growth-negative
Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
Chiesi Global Rare Diseases and Protalix Biotherapeutics have received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the approval of a new dosing regimen for Elfabrio. The proposed regimen of 2 mg/kg every four weeks was not approved, maintaining the current regimen of 1 mg/kg every two weeks. Despite the setback, both companies remain committed to reducing the treatment burden for Fabry disease patients. The decision was based on data from clinical trials and modeling analyses, which were deemed insufficient to demonstrate similar efficacy. The companies plan to continue their efforts in supporting the Fabry disease community.
Product StageCustomers
growth-positive
Protalix BioTherapeutics, Inc. (PLX) Gains Investor Confidence With Major Stake Increase
Protalix BioTherapeutics, Inc., a New Jersey-based biopharmaceutical company, is gaining attention as a promising investment opportunity. Goldman Sachs Group Inc. significantly increased its holdings in the company by 482.3% during the first quarter, now owning 289,461 shares valued at approximately $741,000. Protalix specializes in developing recombinant therapeutic proteins through its ProCellEx platform, focusing on rare genetic diseases. The company is expanding its platform to optimize drug delivery, which is seen as a potential game-changer in the industry. Despite the positive outlook for Protalix, some analysts suggest that certain AI stocks may offer greater upside potential.
Investment
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $159.9M |
| Last funding | $40M |
| Stage | Public |
| Rounds | 11 |
| Investors | 5 |
Team Members
6
Employees: 51-200
Web & Social Links
| Website | protalix.com |
| Careers | Careers page |
Locations
Snunit St 2, Karmiel, Israel
Photos & Videos
1 item(s)
Protalix BioTherapeutics Business
Business models
B2B
Product stage
Released
Employees
51-200
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrugs Discovery & DevelopmentTarget Customer
Healthcare & Life SciencesLife SciencesPharmaceuticalsCore Technology
BiologicalsMoleculesTags (9)
antibodiesoral-drugspharmaceuticalsproteinsgenetic-disordersplant-proteininflammatory-diseasespharma-companiesdrug-developmentGeographic Markets
MexicoUruguayChileCanadaAustraliaUnited StatesBrazilProtalix BioTherapeutics Financials
$159.9M
Total funding
Undisclosed
Capital raised
$40M
Last funding
Public
Funding stage
11
Total rounds
5
Investors
Cumulative Funding Raised Over Time ($)
$5.3MDec 2005
$49.0MMar 2020
$52.5MOct 2004
$62.5MOct 2015
Private Equity Funding
PIPE
Mar 2020
$43.7M
Psagot Investment House, More Investment House
PIPE
Oct 2015
$10M
Pfizer
C Round
Dec 2005
$5.3M
Aliment Capital, Docor International Management
B Round
Oct 2004
$3.5M
Non-Equity Funding
GrantEvent
Mar 2009
$6M
Office of the Chief Scientist (Lead)
GrantEvent
Apr 2008
$4M
Office of the Chief Scientist (Lead)
Public Offering / Exit
POEvent
Feb 2021
Undisclosed
POEvent
Feb 2012
Undisclosed
POEvent
Mar 2011
Undisclosed
POEvent
Nov 2010
Undisclosed
POEvent
Dec 2006
Undisclosed
Protalix BioTherapeutics Lifecycle
Cumulative Funding Raised Over Time
$5.3MDec 2005
$49.0MMar 2020
$52.5MOct 2004
$62.5MOct 2015
All Events
PIPE
Mar 2020
$43.7M
Psagot Investment House, More Investment House
PIPE
Oct 2015
$10M
Pfizer
C Round
Dec 2005
$5.3M
Aliment Capital, Docor International Management
B Round
Oct 2004
$3.5M
GrantEvent
Mar 2009
$6M
Office of the Chief Scientist (Lead)
GrantEvent
Apr 2008
$4M
Office of the Chief Scientist (Lead)
POEvent
Feb 2021
Undisclosed
POEvent
Feb 2012
Undisclosed
POEvent
Mar 2011
Undisclosed
POEvent
Nov 2010
Undisclosed
POEvent
Dec 2006
Undisclosed
Protalix BioTherapeutics News
155 articles
growth-negative
3 Compelling Penny Stocks With Market Caps Under $600M
Organogenesis Holdings Inc., a company in the regenerative medicine sector, is facing challenges typical for its industry. Despite setbacks in Phase 3 trials for its product ReNu, the product maintains a favorable safety profile and holds a Regenerative Medicine Advanced Therapy designation from the FDA. The company, with a market cap of $540.41 million, remains unprofitable but has improved its net loss and forecasts revenue growth up to $510 million by the end of 2025. Organogenesis operates debt-free but faces cash runway constraints if free cash flow grows at historical rates.
Product StageFDA approved/pending approval
growth-negative
Can Protalix (PLX) Turn Regulatory Setbacks Into a Competitive Advantage in Rare Disease Markets?
The European Medicines Agency (EMA) issued a negative opinion on Protalix BioTherapeutics and Chiesi Groups request for a less frequent dosing schedule for Elfabrio in Fabry disease, citing insufficient data. This regulatory setback highlights challenges in modifying dosing regimens to reduce patient treatment burdens. Despite this, the FDAs approval of Elfabrio in May 2025 underscores its commercial potential, with ongoing efforts for label expansion. The EMAs decision raises questions about short-term revenue growth but does not affect the initial FDA approval in the US. Protalix is projected to reach significant revenue and earnings growth by 2028, with a fair value estimate suggesting a substantial upside to its current stock price.
FDA approvedProduct StagePartners
growth-negative
Protalix BioTherapeutics (PLX): Evaluating Valuation After EMA Setback on Elfabrio Dosing Regimen
Protalix BioTherapeutics experienced a significant drop in share price following a negative opinion from the European Medicines Agency (EMA) regarding a proposed dosing schedule for its Fabry disease therapy, Elfabrio. The companys stock fell by 22.5% in a single day, erasing recent gains. Despite this setback, Protalix has shown a 1-year total shareholder return of over 70%. The market is currently debating whether the company is undervalued, with shares trading below analyst targets. The companys future growth prospects are influenced by ongoing regulatory challenges and geopolitical instability. Protalix has no debt and potential lucrative therapies in its pipeline, which could drive future growth if approved.
growth-negative
Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
Chiesi Global Rare Diseases and Protalix Biotherapeutics have received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the approval of a new dosing regimen for Elfabrio. The proposed regimen of 2 mg/kg every four weeks was not approved, maintaining the current regimen of 1 mg/kg every two weeks. Despite the setback, both companies remain committed to reducing the treatment burden for Fabry disease patients. The decision was based on data from clinical trials and modeling analyses, which were deemed insufficient to demonstrate similar efficacy. The companies plan to continue their efforts in supporting the Fabry disease community.
Product StageCustomers
growth-positive
Protalix BioTherapeutics, Inc. (PLX) Gains Investor Confidence With Major Stake Increase
Protalix BioTherapeutics, Inc., a New Jersey-based biopharmaceutical company, is gaining attention as a promising investment opportunity. Goldman Sachs Group Inc. significantly increased its holdings in the company by 482.3% during the first quarter, now owning 289,461 shares valued at approximately $741,000. Protalix specializes in developing recombinant therapeutic proteins through its ProCellEx platform, focusing on rare genetic diseases. The company is expanding its platform to optimize drug delivery, which is seen as a potential game-changer in the industry. Despite the positive outlook for Protalix, some analysts suggest that certain AI stocks may offer greater upside potential.
Investment
growth-positive
3 Penny Stocks With Market Caps Over $30M To Consider
Protalix BioTherapeutics, Inc., a biopharmaceutical company, focuses on developing and commercializing recombinant therapeutic proteins using its ProCellEx plant cell-based protein expression system. The company has recently turned profitable, reporting a net income of $0.164 million in Q2 2025. With no debt and strong short-term assets, Protalix is in a solid financial position. Recent management changes include the appointment of Gilad Mamlok as CFO, which is expected to bring extensive capital markets experience to the company. Protalixs addition to multiple Russell indices highlights growing investor recognition. The company operates in the biotechnology sector, with a market cap of $144.32 million.
Management Changes
growth-positive
Presenting at the Investor Summit Q3 2025 on September 16; Watch the Live Stream for Free
The Investor Summit Group is hosting its Q3 Investor Summit Virtual on September 16, 2025. This event is designed to enhance visibility for issuers and efficiency for investors by showcasing companies with strong leadership and innovative products. The summit serves as a platform for connecting quality companies with serious investors. The event features a schedule of presentations from various companies across different sectors, providing an opportunity for these companies to present their growth strategies and innovations to potential investors. The summit is a significant opportunity for companies to gain exposure and for investors to discover promising investment opportunities.
growth-positive
Protalix BioTherapeutics to Present at Investor Summit Virtual
Protalix BioTherapeutics, Inc., a biopharmaceutical company, is set to present at the Investor Summit Virtual on September 16, 2025. The company focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its products, including taliglucerase alfa and Elfabrio, the latter also approved by the European Medicines Agency. The company has partnered with Pfizer for the global commercialization of taliglucerase alfa and with Chiesi Farmaceutici for Elfabrio. Protalixs pipeline includes products targeting pharmaceutical markets, such as PRX-115 and PRX-119. The Investor Summit will highlight growth strategies and market opportunities for small and microcap stocks.
Management ChangesPartnersFDA approved
growth-positive
Protalix BioTherapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference in September 2025. The company focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its products, including Elfabrio, which was approved in May 2023. The company has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalixs pipeline includes products targeting established pharmaceutical markets, such as treatments for uncontrolled gout and NETs-related diseases.
PartnersFDA approved
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, is set to present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8–10, 2025. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production and has licensed rights to Pfizer for taliglucerase alfa, excluding Brazil. Additionally, Protalixs product Elfabrio has been approved by both the FDA and the European Medicines Agency. The company has partnered with Chiesi Farmaceutici for the global development of Elfabrio and continues to develop other therapeutic proteins targeting established pharmaceutical markets.
FDA approved/pending approvalPartnersProduct Stage
growth-positive
PLX: New CFO to Take the Reins
Protalix BioTherapeutics, Inc. reported its second quarter 2025 financial and operational results, highlighting a 16% increase in revenues driven by higher sales of Elfabrio, despite a decline in Elelyso sales. The company plans to launch the PRX-115 trial in the second half of the year. A new CFO, Gilad Mamlok, will take over from Eyal Rubin. Protalix aims to achieve $100 million in royalty revenues by 2030, targeting a 15% to 20% market share in the Fabry market. The company experienced a net income of $164,000 compared to a net loss in the previous year, and it was added to the Russell 2000 and 3000 indices.
Management ChangesCustomersProduct Stage
growth-positive
Protalix BioTherapeutics Reports Second Quarter 2025 Financial and Business Results
Protalix BioTherapeutics, Inc. reported a 50% increase in revenues for the first half of 2025, driven by sales of Elfabrio® to Chiesi. The company is in the early launch phase for Elfabrio, targeting the Fabry disease market, which is expected to grow significantly by 2030. Protalix is also advancing its PRX-115 product candidate for uncontrolled gout, with a Phase 2 trial anticipated in late 2025. The company announced a management change, with Eyal Rubin stepping down as CFO, to be succeeded by Gilad Mamlok. The company is confident in its growth trajectory and strategic plans.
CustomersPartnersManagement Changes
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced it will release its financial results for the quarter ended June 30, 2025, and provide a business and clinical update on August 14, 2025. The company focuses on developing recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. Protalix has achieved FDA approval for its products, including taliglucerase alfa and Elfabrio. The company has partnered with Pfizer for the global rights to taliglucerase alfa, excluding Brazil, and with Chiesi Farmaceutici for the global development of Elfabrio. Protalixs pipeline includes products targeting established pharmaceutical markets, such as PRX–115 and PRX–119.
Product StagePartnersFDA approved/pending approval
growth-positive
Protalix BioTherapeutics to Announce Second Quarter 2025 Financial and Business Results on August 14, 2025
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced it will release its financial results for the quarter ended June 30, 2025, and provide a business and clinical update on August 14, 2025. The company focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production system and has licensed worldwide rights to taliglucerase alfa to Pfizer Inc., except in Brazil. Additionally, its product Elfabrio® received FDA and European Medicines Agency approval in May 2023. The company will host a conference call to discuss its financial results and recent developments.
Product StageCustomersPartnersFDA approved/pending approval
growth-positive
Protalix BioTherapeutics Appoints Gilad Mamlok as its New Senior Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc. announced the appointment of Gilad Mamlok as the new Senior Vice President and Chief Financial Officer, effective August 24, 2025. This management change is part of Protalixs strategy to strengthen its financial and capital status. Mamlok brings extensive experience in healthcare and technology sectors, having previously served as CFO at TytoCare Ltd. and Sol-Gel Technologies Ltd. Protalix is known for its proprietary ProCellEx plant cell-based protein expression system and has achieved FDA approval for its products, including taliglucerase alfa and Elfabrio®. The company has a partnership with Pfizer for the worldwide commercialization of taliglucerase alfa, except in Brazil.
Management Changes
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced the appointment of Gilad Mamlok as the new Senior Vice President and Chief Financial Officer, effective August 24, 2025. Mamlok, with extensive experience in healthcare and technology companies, will succeed Eyal Rubin, who will remain available until October 2025. Protalix focuses on developing recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. The company has FDA approval for its products, including Elfabrio, and has partnered with Chiesi Farmaceutici for global commercialization. The management change is expected to support Protalixs growth strategy.
Management ChangesPartnersFDA approved
growth-positive
Fabry Disease Treatment Analysis Report 2025 | Market to Reach $3.86 Billion by 2030, Rising Fabry Disease Prevalence and Demand for Targeted Therapies Drive Growth
The global Fabry disease treatment market is expected to grow significantly from USD 2.22 billion in 2024 to USD 3.86 billion by 2030. This growth is driven by the increasing prevalence of Fabry disease, advancements in therapies, and heightened awareness. Key players in this market include Sanofi, Amicus Therapeutics, and Protalix BioTherapeutics. Recent developments include UniQure Biopharmas completion of enrollment in a Phase I/IIa trial, FDAs Orphan Drug Designation for EXG110, and Sangamo Therapeutics alignment with the FDA for accelerated approval of isaralgagene civaparvovec. The enzyme replacement therapy remains the standard of care, while chaperone treatment and substrate reduction therapy are gaining traction.
Product StageFDA approved/pending approval
growth-positive
Protalix BioTherapeutics Added to Russell 3000® and 2000 Indexes®
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has been added to the Russell 3000® and Russell 2000® Indexes as part of the 2025 Russell indexes annual reconstitution. This inclusion, effective June 27, 2025, enhances the companys visibility and is expected to positively impact its strategic growth. Protalix focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based protein expression system. The company has achieved FDA approval for its products, including taliglucerase alfa for Gaucher disease and Elfabrio®, which was approved by both the FDA and the European Medicines Agency in May 2023. The inclusion in these indexes is significant as they are widely used by investment managers and institutional investors for benchmarking and active investment strategies.
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, will participate in the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at Nasdaq headquarters in New York City. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production system and has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. The company has a pipeline of products targeting established pharmaceutical markets, including treatments for Gaucher disease and uncontrolled gout.
PartnersFDA approved/pending approval
growth-positive
Protalix BioTherapeutics to Present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference at Nasdaq NYC
Protalix BioTherapeutics, Inc., a biopharmaceutical company, will participate in the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at Nasdaq headquarters in New York City. The company, known for its proprietary ProCellEx plant cell-based protein expression system, has achieved FDA approval for its products, including Elfabrio®, which is also approved by the European Medicines Agency. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. The company has licensed Pfizer Inc. for the worldwide rights to taliglucerase alfa for Gaucher disease, excluding Brazil. Protalixs pipeline includes products targeting established pharmaceutical markets.
PartnersFDA approved/pending approval
growth-negative
PLX: First Quarter Results
Protalix Biotherapeutics, Inc. reported its first-quarter 2025 financial and operational results, highlighting significant growth in Elelyso sales to Pfizer and Brazil. However, the company did not recognize any Elfabrio revenues, which could impact its 2025 revenue estimates. The company is advancing towards a Phase II trial for PRX-115, expected to start in the second half of 2025. Financially, Protalix saw a 170% increase in revenues to $10.1 million, driven by Elelyso sales, but also experienced a net loss of $3.6 million. The lack of Elfabrio revenues and managements lack of revenue visibility for the year have led to a reduction in the companys valuation.
CustomersProduct Stage
growth-positive
Protalix BioTherapeutics Inc (PLX) Q1 2025 Earnings Call Highlights: Revenue Surge and ...
Protalix BioTherapeutics Inc reported a significant revenue increase, reaching $10 million, a 170% rise from the previous year. The company is advancing its clinical development, with plans to initiate a phase two trial for PRX 115 for gout. Protalix is also evaluating other pipeline candidates like PRX 119. The company has a strong partnership with PSE Global Rural Diseases, which is investing in its programs. Despite increased costs and potential competition in the gout market, Protalix maintains a solid financial position with $34.7 million in cash and equivalents. The company faces uncertainty regarding the approval of a dosing frequency change for El Faulo by the EMA.
Product StageCustomersPartners
growth-negative
Protalix: Q1 Earnings Snapshot
Protalix BioTherapeutics Inc., a drug development company based in Hackensack, New Jersey, reported a financial loss of $3.6 million in its first quarter. The loss translates to 5 cents per share. Despite the loss, the company generated $10.1 million in revenue during the same period. The report was generated using data from Zacks Investment Research and highlights the financial challenges faced by the company in the current quarter.
growth-positive
Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results
Protalix BioTherapeutics, Inc. reported financial results for Q1 2025, highlighting increased revenues and progress in its clinical pipeline. The company is advancing its PRX-115 candidate for gout treatment, having completed a successful phase I trial in 2024 and preparing for a phase II trial in 2025. The promising results suggest potential for effective uric acid-lowering treatment. Additionally, Protalixs partner, Chiesi Global Rare Diseases, presented on pegunigalsidase alfa for Fabry Disease at a recent symposium. The companys focus on clinical advancements and partnerships indicates a positive growth trajectory.
Product StagePartners
growth-positive
Protalix BioTherapeutics to Announce First Quarter 2025 Financial and Business Results on May 9, 2025
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced it will release its financial results for the quarter ended March 31, 2025, and provide a business and clinical update on May 9, 2025. The company will host a conference call to discuss these results and recent corporate and regulatory developments. Protalix focuses on developing and commercializing recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. Notably, Protalix is the first company to receive FDA approval for a protein produced through a plant cell-based suspension expression system. The company has licensed worldwide rights to taliglucerase alfa to Pfizer, except in Brazil. Additionally, its second product, Elfabrio®, received FDA and European Medicines Agency approval in May 2023.
growth-negative
Top Penny Stocks To Watch In April 2025
Origin Materials, Inc., a carbon-negative materials company with a market cap of $102.24 million, is facing challenges typical of penny stocks. Despite generating $31.28 million in revenue from its Specialty Chemicals segment, the company remains unprofitable and has seen increased losses over five years. The stock is at risk of delisting from Nasdaq due to a prolonged sub-$1 bid price, with a deadline of October 2025 to regain compliance. However, the company has improved its financial health by reducing its debt-to-equity ratio and has short-term assets exceeding liabilities. Future growth is anticipated with new production lines and expected revenue increases in 2026.
Public Trading
growth-negative
Protalix BioTherapeutics And 2 Other Promising Penny Stocks
Protalix BioTherapeutics, Inc., a biopharmaceutical company with a market cap of $202.88 million, focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx system. Despite a decline in revenue from $65.49 million to $53.4 million and a drop in net income to $2.93 million, the company remains profitable with high-quality earnings. The company has avoided shareholder dilution and maintains no debt, with short-term assets covering liabilities. Recent bylaw changes aim to strengthen corporate governance, and upcoming conference presentations may offer insights into strategic directions amidst challenges like reduced profit margins.
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, will participate in the iAccess Alpha Virtual Best Ideas Spring Investment Conference 2025. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its products, including Elfabrio, which is also approved by the European Medicines Agency. The company has partnered with Chiesi Farmaceutici for the global development and commercialization of Elfabrio. Protalixs pipeline includes products targeting established pharmaceutical markets, such as treatments for uncontrolled gout and NETs-related diseases. The conference will feature webcast presentations and one-on-one meetings with investors.
PartnersFDA approved/pending approval
growth-positive
Protalix BioTherapeutics to Present at the iAccess Alpha Virtual Best Ideas Spring Conference 2025
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced its participation in the iAccess Alpha Virtual Best Ideas Spring Investment Conference 2025. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production, with its first product, taliglucerase alfa, licensed to Pfizer for global commercialization, excluding Brazil. Its second product, Elfabrio®, received FDA and European Medicines Agency approval in May 2023. The conference will feature webcast presentations and one-on-one meetings with investors, highlighting Protalixs innovative approach and potential growth opportunities.
FDA approved/pending approvalPartners
growth-positive
Is Protalix BioTherapeutics (PLX) The High Growth Low Debt Stock to Invest in Now?
The article discusses the investment potential of Protalix BioTherapeutics, Inc. (NYSEAMERICAN:PLX) as a high-growth, low-debt stock amidst current market volatility. It highlights the advantages of investing in companies with low debt levels, which include financial stability, reduced bankruptcy risk, and greater flexibility for growth opportunities. The article emphasizes the importance of focusing on asset quality and financial resilience in the current economic climate. It also notes that historically, low-debt growth companies have outperformed their high-debt counterparts, making them attractive to investors seeking robust earnings growth and operational flexibility.
growth-positive
iAccess Alpha's Virtual Best Ideas Spring Investment Conference March 25-26, 2025
iAccess Alpha is hosting its Virtual Best Ideas Spring Investment Conference on March 25-26, 2025. The event aims to connect micro-cap companies with investors, offering live-streamed presentations and exclusive 1x1 meetings. The conference is part of a series held quarterly, focusing on high-potential investment opportunities. iAccess Alpha has been organizing these events since 2019, facilitating connections between investors and promising companies. The event is expected to enhance networking and investment opportunities for participating companies and investors.
growth-positive
Protalix BioTherapeutics Inc (PLX) Q4 2024 Earnings Call Highlights: Record Revenue Growth ...
Protalix BioTherapeutics Inc (PLX) reported record revenues for 2024, driven by increased sales to partners like Chiesi and Pfizer. The company has fully repaid its outstanding debt, strengthening its financial position. Protalix is advancing its R&D efforts, particularly with PRX-115, which completed a successful Phase 1 trial and is preparing for Phase 2. The European Medicines Agency validated a new dosing regimen for Elfabrio, potentially expanding its market in the EU. Despite a decrease in net income and R&D expenses, the company anticipates significant revenue growth from royalties by 2030. The collaboration with Chiesi is progressing well, with expectations of revenues exceeding $100 million by 2030. However, Protalix did not provide specific revenue guidance for 2025, creating some uncertainty about future financial performance.
CustomersPartnersProduct Stage
growth-positive
PLX: 2024 Results
Protalix Biotherapeutics, Inc. reported its 2024 financial and operational results, highlighting a 31% increase in product revenues driven by Elfabrio sales to Chiesi. The company completed the Phase I trial of PRX-115 for gout and plans a Phase II study in the second half of 2025. Despite a decline in overall revenues due to a previous milestone recognition, Protalix achieved a net income of $3.2 million. The company repaid its convertible debt and raised additional funds through equity issuance and warrant exercises. Partnerships with Chiesi, Pfizer, and Fiocruz contributed to revenue growth. The cash balance at year-end was $34.8 million, reflecting positive cash flow and strategic financial management.
Product StageCustomersPartnersPIPE/PO
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
growth-positive
Protalix BioTherapeutics Reports Fiscal Year 2024 Financial and Business Results
Protalix BioTherapeutics, Inc. reported a record year in revenues for 2024, with increases in all revenue streams from partners Chiesi, Pfizer, and Brazil. The company successfully completed a phase I clinical trial for its gout treatment candidate, PRX-115, and plans to initiate a phase II trial in 2025. Protalix also announced that the European Medicines Agency validated a variation submission for pegunigalsidase alfa, a treatment for Fabry disease, in collaboration with Chiesi Global Rare Diseases. The company has strengthened its financial position by fully repaying its debt and eliminating outstanding warrants, positioning itself for continued strategic execution.
CustomersProduct StagePartners
growth-positive
Protalix BioTherapeutics to Announce Fiscal Year 2024 Financial and Business Results on March 17, 2025
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced it will release its financial results for the fiscal year ending December 31, 2024, and provide a business and clinical update on March 17, 2025. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system. Protalix is notable for being the first to gain FDA approval for a protein produced through this method. The company has licensed worldwide rights to taliglucerase alfa to Pfizer, excluding Brazil. Additionally, Protalixs second product, Elfabrio®, received FDA and European Medicines Agency approval in May 2023.
FDA approved/pending approvalPartners
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
growth-negative
3 US Penny Stocks With Market Caps Under $400M To Watch
GoPro, Inc. is navigating the challenges of being a penny stock with a market cap of approximately $0.15 billion. Despite facing financial hurdles due to unprofitability and increased losses over recent years, the company has maintained a stable debt position with more cash than total debt. GoPro has reduced its debt-to-equity ratio significantly over the past five years. The company is focusing on recent product upgrades and strategic partnerships, such as those in the MotoGP racing series, to enhance its brand visibility and appeal in the action camera market. These efforts aim to support future revenue streams despite current financial challenges.
Partners
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, is set to present at the 2025 BIO CEO & Investor Conference in New York City. The company specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production and has licensed rights to Pfizer for taliglucerase alfa, excluding Brazil. Additionally, Protalixs Elfabrio® received FDA and European Medicines Agency approval in May 2023. The company has partnered with Chiesi Farmaceutici S.p.A. for Elfabrios global development and commercialization. Protalixs pipeline includes products targeting pharmaceutical markets, such as PRX–115 for gout and PRX–119 for NETs-related diseases.
PartnersFDA approved/pending approval
growth-positive
Protalix BioTherapeutics to Participate in the 2025 BIO CEO & Investor Conference
Protalix BioTherapeutics, Inc., a biopharmaceutical company, is set to present at the 2025 BIO CEO & Investor Conference in New York City. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system. Protalix has achieved FDA approval for its plant cell-based protein production method, with products like taliglucerase alfa and Elfabrio® already approved. The company has partnered with Pfizer for the global rights to taliglucerase alfa, excluding Brazil, and with Chiesi Farmaceutici for Elfabrio. Protalixs pipeline includes products targeting gout and NETs-related diseases. The conference will provide opportunities for Protalix to engage with investors and potential partners.
PartnersFDA approved/pending approval
growth-positive
PLX: Revisiting the Thesis
Protalix Biotherapeutics, Inc. is in a strong position as of 2025, with two approved products generating revenue and a promising pipeline. The company uses its ProCellEx platform to produce therapeutic proteins and has eliminated all debt, holding over $27 million in cash. Its product Elelyso, approved for Gaucher disease, is sold globally through agreements with Pfizer and Fiocruz. Elfabrio, approved by the FDA and EMA for Fabry disease, targets a $2 billion market. A new dosing regimen for Elfabrio is under review by the EMA, potentially reducing administration frequency and offering a competitive advantage. The companys financial health and strategic partnerships position it for continued growth.
Product StagePartnersFDA approved/pending approval
growth-positive
US Penny Stocks: Arbe Robotics And 2 More Promising Picks
Arbe Robotics Ltd., a semiconductor company specializing in 4D imaging radar solutions, is gaining attention due to its recent collaboration with NVIDIA. Despite being pre-revenue with sales of US$0.67 million for the first nine months of 2024, the company has a market cap of US$340.27 million. Arbe Robotics is positioned as a potential innovator in vehicle safety and autonomy sectors, thanks to its advanced radar technology. The company faces challenges such as unprofitability and a high net debt to equity ratio, but it maintains financial stability with short-term assets exceeding liabilities. Shareholder dilution is a concern due to recent equity offerings aimed at increasing cash reserves amidst growing losses.
Partners
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has achieved significant milestones in 2024, positioning itself for long-term growth. The company has made progress in its pipeline programs, including a phase I clinical trial for PRX 115, a treatment for uncontrolled gout, and plans to advance to phase II in 2025. Protalixs commercial partner, Chiesi Global Rare Diseases, has had its Variation Submission for pegunigalsidase alfa validated by the European Medicine Agency, exemplifying their commitment to reducing treatment burdens for Fabry disease patients. Protalix has also maintained uninterrupted operations despite military conflicts in Israel. The company is debt-free after repaying all outstanding convertible notes, and it continues to grow its sales through partnerships with Chiesi, Pfizer, and Brazil.
Partners
growth-positive
Protalix BioTherapeutics Issues 2025 Letter to Stockholders
Protalix BioTherapeutics, Inc. has made significant progress in 2024, positioning itself for long-term growth. The company, in collaboration with its commercial partner Chiesi Global Rare Diseases, has achieved a milestone with the European Medicine Agency validating a less frequent dosing regimen for pegunigalsidase alfa for Fabry disease. Protalix has also completed a phase I clinical trial for PRX-115, a potential treatment for uncontrolled gout, and plans to advance to phase II trials in 2025. The company is focusing on its R&D strategy, leveraging its ProCellEx platform for renal rare diseases. Protalix has seen growth in sales to Chiesi, Pfizer Inc., and Brazil, contributing to its revenue streams.
PartnersCustomers
growth-positive
EMA validates Chiesi and Protalix’s dose variation for Fabry disease
Protalix BioTherapeutics, in partnership with Chiesi Global Rare Diseases, has received validation from the European Medicines Agency (EMA) for a new dosing regimen of pegunigalsidase alfa, a therapy for Fabry disease. The proposed regimen, which suggests a dose of 2 mg/kg every four weeks, is backed by clinical data from the Phase III BRIGHT trial. This new regimen aims to reduce the treatment burden for adults with Fabry disease. The partnership between Protalix and Chiesi focuses on the global development and commercialization of this therapy. The validation marks a significant milestone in providing innovative solutions for patients with unmet medical needs.
Partners
growth-negative
Promising US Penny Stocks To Watch In December 2024
Tandy Leather Factory, Inc., a company in the penny stock market, has shown resilience with a market cap of $33.77 million and revenue of $74.76 million from its Apparel segment. Despite maintaining strong financial health with short-term assets exceeding liabilities and operating debt-free, the company reported a net loss in Q3 2024, contrasting with profits from the previous year. Over the past five years, Tandys earnings growth has been robust at an average of 66.6% annually, although it has recently slowed to 6.7%. A strategic decision to sell its headquarters for $26.5 million and relocate by September 2025 is part of its recent moves. The article highlights the companys financial position and potential in the penny stock market.
growth-positive
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa
Chiesi Global Rare Diseases, in partnership with Protalix BioTherapeutics, announced that the European Medicines Agency (EMA) has validated a Variation Submission for a new dosing regimen of pegunigalsidase alfa for Fabry disease. The new regimen involves a 2 mg/kg dose administered every four weeks, compared to the current 1 mg/kg every two weeks. This change is based on a revised Population-PK model, new exposure-response analyses, and clinical data from the Phase 3 study PB-102-F50 and its extension study. The validation marks a significant milestone in reducing treatment burdens for patients with Fabry disease. Both companies are committed to providing innovative therapies and look forward to working with the EMA to bring this alternative dosing option to market.
Partners
growth-positive
Protalix BioTherapeutics Inc (PLX) Q3 2024 Earnings Call Highlights: Revenue Surge and ...
Protalix BioTherapeutics Inc (PLX) reported a significant increase in revenue from selling goods, driven by increased sales to Chiesi and Pfizer, marking a 75% rise compared to the previous year. The company has become debt-free after repaying all outstanding principal and interest under its senior secured convertible promissory notes. Protalix completed all eight cohorts of the Phase I clinical trial for PRX-115, showing promising results, and is preparing for a Phase II trial in 2025. Despite a decrease in license and R&D service revenues and an increase in the cost of goods sold, the company reported a net income of $3.2 million. Protalix maintains a strong balance sheet with $27.4 million in cash and cash equivalents. The company faces competitive challenges in the treatment of refractory gout and is not pursuing manufacturing contracts with other companies.
Customers
growth-positive
PLX: Self-Sustaining Rise to Lead in Renal Rare Disease
Protalix Biotherapeutics, Inc. reported its third quarter 2024 financial and operational results, highlighting a 74% increase in revenues to $18.0 million, primarily driven by strong sales from Chiesi related to Elfabrio. The company achieved a net income of $3.2 million, a significant turnaround from a net loss in the previous year. Protalix has repaid its convertible debt and completed the eighth cohort of its Phase I PRX-115 trial in gout, with Phase II planned for the second half of 2025. The companys financial performance was bolstered by increased Elelyso sales to Pfizer and Brazil, although research and development expenses decreased due to the completion of the Fabry clinical program. Overall, the results indicate a positive growth trajectory for Protalix.
Customers
growth-positive
Protalix BioTherapeutics Reports Third Quarter 2024 Financial and Business Results
Protalix BioTherapeutics, Inc. reported financial results for Q3 2024 and provided updates on its clinical pipeline. The company completed its phase I study of PRX-115, a recombinant uricase candidate for treating uncontrolled gout. Preliminary results are promising, showing potential as a uric-acid lowering treatment. The study involved 64 subjects across eight cohorts, with PRX-115 demonstrating dose-dependent efficacy and being well-tolerated. Protalix plans to initiate a phase II trial in the second half of 2025. The positive results and future plans indicate a growth-positive impact for the company.
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, reported positive preliminary results from its phase I clinical trial of PRX-115, a treatment for uncontrolled gout. The study demonstrated promising uric acid-lowering effects and was well-tolerated by participants. The company plans to initiate a phase II trial in 2025. Financially, Protalix saw a 75% increase in revenue from selling goods in Q3 2024, primarily due to increased sales to partners Chiesi Farmaceutici S.p.A. and Pfizer Inc. The company also repaid its convertible notes using available cash. These developments indicate a positive growth trajectory for Protalix, supported by strong partnerships and promising clinical advancements.
CustomersPartners
growth-positive
Protalix: Q3 Earnings Snapshot
Protalix BioTherapeutics Inc., a biotechnology company based in Hackensack, New Jersey, reported a profit of $3.2 million for its third quarter. This translates to earnings of 3 cents per share. The company also posted revenue of $18 million during this period. The report was generated using data from Zacks Investment Research and highlights a positive financial performance for the company in the third quarter.
growth-positive
Protalix BioTherapeutics to Announce Third Quarter 2024 Financial and Business Results on November 14, 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced it will release its financial results for the quarter ending September 30, 2024, and provide a business and clinical update on November 14, 2024. The company will host a conference call and webcast to discuss these results and recent corporate and regulatory developments. Protalix focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. The company has achieved FDA approval for its plant cell-based protein production method and has licensed worldwide rights to taliglucerase alfa to Pfizer, excluding Brazil. Protalixs second product, Elfabrio, received FDA and European Medicines Agency approval in May 2023.
growth-positive
Accolade And 2 Other Penny Stocks To Watch On US Exchanges
The article discusses the interest in penny stocks as major U.S. indexes face a downturn due to disappointing earnings from big tech companies. Investors are looking for alternative opportunities, with penny stocks offering potential value and growth. Accolade, Inc. is highlighted as a company with a market cap of approximately $265.77 million, showing revenue growth despite being unprofitable. The company has a strong financial position with short-term assets exceeding liabilities and a cash runway for over three years. Accolades shares have recently been diluted, but it remains an intriguing investment option due to its financial resilience and growth potential.
growth-positive
Protalix BioTherapeutics to Present Phase I PRX-115 Data in Late-Breaking Poster at ACR Convergence 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that data from its phase I clinical trial of PRX-115, a recombinant PEGylated uricase product candidate for treating uncontrolled gout, will be presented at the American College of Rheumatology (ACR) Convergence 2024. The event will take place from November 14-19, 2024, in Washington, D.C. Protalix is known for its proprietary ProCellEx plant cell-based protein expression system, which has been used to develop FDA-approved products. The company has a licensing agreement with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, except in Brazil. Protalixs second product, Elfabrio®, received FDA and European Medicines Agency approval in May 2023.
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced the presentation of data from its phase I clinical trial for PRX-115, a recombinant PEGylated uricase product candidate for treating uncontrolled gout. The presentation will occur at the ACR Convergence 2024 in Washington, D.C. Protalix uses its proprietary ProCellEx plant cell-based protein expression system to develop therapeutic proteins. The company has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio, another product in its pipeline. Protalixs innovative approach and partnerships indicate a positive growth trajectory, as it continues to advance its product candidates targeting established pharmaceutical markets.
Partners
growth-positive
OTC Markets Hosts Virtual Investor Presentation with Dror Bashan, President & CEO of Protalix Biotherapeutics, and John Vandermosten, Senior Analyst at Zacks SCR
Protalix Biotherapeutics, a biotech company trading under the symbol PLX, has successfully paid off its debt, showcasing a strong financial position with $45 million in cash. The company generates revenue from two commercialized products, Elfabrio and ELELYSO, targeting Fabry and Gaucher diseases. Elfabrio, approved in May 2023, has been launched in the US and Europe, with Chiesi as the commercial partner working to expand its market availability. Protalixs development pipeline includes treatments for gout and rare renal diseases. The companys financial stability and product commercialization efforts indicate a positive growth trajectory.
CustomersPartners
growth-positive
Life Sciences Virtual Investor Forum Presentations Now Available for Online Viewing
Virtual Investor Conferences (VIC), a leading proprietary investor conference series, announced that presentations from the Life Sciences Virtual Investor Forum held on September 19, 2024, are now available for online viewing. The event was co-sponsored by Zacks Small-Cap Research. The presentations will be accessible 24/7 for 90 days, and select companies are accepting one-on-one management meeting requests through September 24th. VIC provides an interactive forum for publicly traded companies to present directly to investors, enhancing investor engagement through dynamic video content and targeted meetings.
Partners
growth-positive
Life Sciences Virtual Investor Forum Agenda Announced for September 19th
Virtual Investor Conferences (VIC) announced the agenda for the Life Sciences Virtual Investor Forum, scheduled for September 19th, 2024. Co-sponsored by Zacks Small-Cap Research, the event invites individual and institutional investors, advisors, and analysts to attend. The forum aims to provide an efficient platform for companies to engage with their investor base through live presentations and one-on-one meetings. Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group, emphasized the events role in enhancing investor relations. VIC offers a real-time engagement solution for publicly traded companies, replicating the components of an on-site investor conference.
Partners
growth-positive
Protalix BioTherapeutics to Present at the Life Sciences Investor Forum September 19, 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that its President and CEO, Dror Bashan, will present at the Life Sciences Investor Forum on September 19, 2024. The event, hosted by VirtualInvestorConferences.com, will be an interactive online session where investors can ask questions in real-time. Protalix focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. The company has partnerships with Pfizer for the commercialization of taliglucerase alfa and with Chiesi Farmaceutici for Elfabrio. The event aims to enhance investor engagement and provide updates on Protalixs product pipeline and business strategy.
Partners
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company specializing in recombinant therapeutic proteins, announced that its President and CEO, Dror Bashan, will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. The company focuses on developing proteins using its proprietary ProCellEx® plant cell-based expression system. Protalix has licensed the global rights for taliglucerase alfa to Pfizer, except in Brazil, and has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio®. The company’s pipeline includes products targeting established pharmaceutical markets.
Partners
growth-positive
Protalix BioTherapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that its President and CEO, Dror Bashan, will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. Protalix has partnerships with Pfizer for the development and commercialization of taliglucerase alfa and with Chiesi Farmaceutici for Elfabrio. The company has a pipeline of products targeting established pharmaceutical markets.
Partners
growth-positive
Protalix BioTherapeutics Announces Repayment of Outstanding Senior Secured Convertible Promissory Notes
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that it has fully repaid its 7.50% Senior Secured Convertible Promissory Notes, making the company debt-free. This repayment, financed entirely with available cash, marks a significant milestone for Protalix, strengthening its balance sheet and eliminating potential equity overhang. Protalix focuses on developing recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. The company has partnerships with Pfizer Inc. for the commercialization of taliglucerase alfa and with Chiesi Farmaceutici S.p.A. for Elfabrio. Protalixs development pipeline includes products targeting various pharmaceutical markets.
InvestmentPartners
growth-positive
/PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization...
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that it has fully repaid its 7.50% Senior Secured Convertible Promissory Notes, making the company debt-free. This repayment, financed entirely with available cash, marks a significant milestone for Protalix, strengthening its balance sheet to support ongoing operations. The company focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system. Protalix has partnerships with Pfizer Inc. for the global development and commercialization of taliglucerase alfa and with Chiesi Farmaceutici S.p.A. for Elfabrio. The company’s development pipeline includes products targeting established pharmaceutical markets.
InvestmentPartners
growth-positive
Is Protalix BioTherapeutics, Inc. (PLX) The Best Rated Penny Stock To Buy According to Analysts?
Protalix BioTherapeutics, Inc. (NYSE:PLX), a biopharmaceutical company based in Israel, is highlighted as one of the best-rated penny stocks with an impressive upside potential of 1,422%. Despite reporting a Q2 2024 EPS of -$0.03 and revenue of $13.30 million, the company exceeded revenue expectations by $804,000. Protalix is advancing its clinical programs, particularly PRX-115 for treating uncontrolled gout, and is preparing for a Phase 2 trial in mid-2025. The company collaborates with Chiesi Global Rare Diseases on the commercialization of Elfabrio and is expanding its R&D efforts. Financially, despite a net loss of $2.2 million, Protalix maintains a strong cash position. The company remains optimistic about its future, focusing on innovation and long-term value creation.
CustomersPartners
growth-positive
PLX: A Focus on Renal Rare Disease
Protalix Biotherapeutics, Inc. announced its Q2 2024 financial and operational results, reporting revenues of $13.5 million, a net loss of $2.3 million, and a cash balance of $45.0 million. The companys partner, Chiesi, has continued commercialization activities for Elfabrio (PRX-102), obtaining additional approvals and launching new studies. Protalix also provided an update on its PRX-115 Phase I trial in gout and launched an eighth cohort for a Phase II study. The company does not anticipate the need to raise capital in the next 12 months due to Elfabrios growth trajectory.
CustomersPartnersManagement Changes
growth-negative
Protalix: Q2 Earnings Snapshot
Protalix BioTherapeutics Inc. reported a loss of $2.2 million in its second quarter. The company, based in Hackensack, New Jersey, posted revenue of $13.5 million in the same period.
Investment
growth-positive
Protalix BioTherapeutics Reports Second Quarter 2024 Financial and Business Results
Protalix BioTherapeutics, Inc. has reported its financial results for Q2 2024, highlighting progress in its early-stage pipeline. The companys revenues from selling goods decreased by 12% compared to the same period in 2023, primarily due to a decrease in sales to Chiesi. However, this was partially offset by increased sales to Brazil and Pfizer. The company also reported positive topline results from the first-in-human Phase I clinical trial of PRX-115, a potential treatment for uncontrolled gout. The companys strong balance sheet allows for the repayment of convertible notes due in September 2024 while maintaining ongoing operations.
InvestmentCustomersPartners
Neutral
Protalix BioTherapeutics to Announce Second Quarter 2024 Financial and Business Results on August 14, 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has announced that it will release its financial results for the quarter ended June 30, 2024, and provide a business and clinical update on August 14, 2024. The companys management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments. Protalix is focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system.
Management Changes
Growth-Positive
Protalix BioTherapeutics to Host In-Person Investor Day to Discuss Current Treatment Landscapes and Clinical Results for Fabry Disease and Uncontrolled Gout
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has announced that it will host an in-person investor day on June 26, 2024. The event will feature presentations by key opinion leaders Aleš Linhart and Naomi Schlesinger, who will discuss the treatment landscape for Fabry disease and uncontrolled gout respectively. The event will also include a corporate overview and strategy presentation by Dror Bashan, Protalixs President and CEO. Protalix focuses on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system.
Partners
growth-positive
Protalix BioTherapeutics to Present at the 2024 BIO International Convention
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that its President and CEO, Dror Bashan, will present at the 2024 BIO International Convention. The presentation will provide an update on corporate matters. The company is known for its development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of its second product, Elfabrio. The companys development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets.
Management ChangesPartners
growth-positive
PLX: First Quarter Update
Protalix Biotherapeutics, Inc. announced its Q1 2024 financial and operational results, reporting revenues of $3.7 million and a net loss of $4.6 million. The companys partner, Chiesi, has continued commercialization activities for Elfabrio (PRX-102), obtaining additional approvals and launching new studies. The companys cash and equivalents balance on March 31, 2024, totaled $48.5 million, an increase from $44.6 million at the end of 2023. Protalix also announced the receipt of $3.7 million from partners for Elelyso sales. The company is planning for a Phase II study and has completed seven cohorts with 42 subjects treated with PRX-115 and 14 with placebo.
CustomersPartnersExpand
growth-negative
Protalix BioTherapeutics Inc (PLX) Q1 2024 Earnings Call Transcript Highlights: Navigating ...
Protalix BioTherapeutics Inc (PLX) reported a decrease in revenue from selling goods by 27% and from license and R&D services by 98% in Q1 2024 compared to Q1 2023. Despite this, the company maintains a strong cash position and is making progress in its development pipeline with PRX-115. The companys second approved drug, ELFABRIO, continues to gain regulatory approvals globally. Sales to Chiesi are expected to increase as future approvals and launches in additional countries are anticipated. However, there are ongoing financial challenges and potential safety concerns that need to be addressed.
CustomersInvestment
growth-positive
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q1 2024 Earnings Call Transcript
Protalix BioTherapeutics, Inc. held its Q1 2024 earnings call, discussing financial results and business updates. The company announced the expansion of its Phase I study of PRX-115 due to encouraging initial results. Preparations for a Phase II clinical trial of PRX-115 have also begun. The companys second approved drug, Elfabrio, continues to gain regulatory approvals for the treatment of adult patients with Fabry disease. The companys strong cash position allows for the repayment of convertible notes due in September 2024. The company recorded revenues from selling goods of $3.7 million for Q1 2024, a decrease of $1.4 million compared to Q1 2023.
CustomersPartnersManagement Changes
growth-positive
Protalix BioTherapeutics Reports First Quarter 2024 Financial and Business Results
Protalix BioTherapeutics, Inc. reported its financial results for Q1 2024 and provided a business and clinical update. The company announced encouraging initial top-line results from the first seven cohorts of the first-in-human phase I clinical trial of its recombinant uricase candidate, PRX-115, enabling the expansion into an eighth cohort and planning for a phase II trial. The companys revenues from selling goods decreased by 27% compared to the same period in 2023, primarily due to a decrease in sales to Pfizer and Brazil. The companys net loss for Q1 2024 was approximately $4.6 million.
Investment
Neutral
Protalix BioTherapeutics to Announce First Quarter 2024 Financial and Business Results on May 10, 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has announced that it will release its financial results for the quarter ended March 31, 2024, and provide a business and clinical update on May 10, 2024. The company will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio, one of its products.
Management Changes
growth-positive
PLX: Elfabrio Geographic Expansion
Protalix Biotherapeutics, Inc. announced its full year 2023 financial and operational results, reporting a net income of $8.3 million, a significant improvement from a loss of $14.9 million in the previous year. Revenues for 2023 were $65.5 million, up 37% from $47.6 million in the prior year. The companys partner, Chiesi, has continued its commercialization activities, obtained additional approvals, and launched new studies for a pediatric indication and for approval in Japan. Protalix also announced that it had dosed its first patient in the Phase I clinical trial for PRX-115 in the treatment of severe gout.
CustomersPartnersExpand
growth-positive
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q4 2023 Earnings Call Transcript
Protalix BioTherapeutics, Inc. reported its Q4 2023 earnings, missing expectations with a reported EPS of $-0.07, compared to the expected $-0.03. Despite this, the company celebrated the approval of its second drug, Elfabrio, for the treatment of adult patients with Fabry disease. The drug has been approved by both the FDA and the EMA, and has also received regulatory approval in the UK, Sweden, and Israel. The companys commercial partner, Chiesi global rare diseases, is focused on the commercial launches of Elfabrio. Protalix also announced the initiation of a Phase 1 clinical trial for PRX-115, a potential treatment for severe gout.
CustomersPartnersManagement Changes
Protalix BioTherapeutics Inc Reports Revenue Growth and Net Income Gain in FY 2023
growth-positive
Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results
Protalix BioTherapeutics, Inc. reported its financial results for the fiscal year ended December 31, 2023, and provided a business update. The company received regulatory approvals for Elfabrio, a treatment for adult patients with Fabry disease, and advanced its pipeline. Its commercial partner, Chiesi Global Rare Diseases, is positioning Elfabrio for global success, with launches underway in the US, the EU, the UK, and other markets. The company also reported revenues from selling goods of $40.4 million for the year, an increase of 60% compared to the previous year. The companys net income for the year was approximately $8.3 million.
CustomersPartners
Neutral
Protalix BioTherapeutics to Announce Fiscal Year 2023 Financial and Business Results on March 14, 2024
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has announced that it will release its financial results for the fiscal year ended December 31, 2023, and provide a business update on Thursday, March 14, 2024. The company is focused on the development, production, and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of its second product, Elfabrio®.
Partners
Growth-Positive
Protalix BioTherapeutics to Participate in the 2024 BIO CEO & Investor Conference
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced its participation in the 2024 BIO CEO & Investor Conference on February 26, 2024. The company will present a corporate overview and will be available for one-on-one partnering meetings with registered investors and other conference attendees. Protalix focuses on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. It has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of its second product, Elfabrio.
Partners
growth-positive
Protalix BioTherapeutics Issues 2024 Letter to Stockholders
Protalix BioTherapeutics, a biopharmaceutical company, has announced that its second development candidate, Elfabrio, has been approved for the treatment of adult patients with Fabry disease by the U.S. Food and Drug Administration and the European Medicines Agency. The company is confident that the commercialization of Elfabrio will improve its capital structure. Protalix has also acknowledged the role of its commercial partner, Chiesi Global Rare Diseases, in its success. The company is also making progress on its pipeline programs, including the phase I clinical trial of PRX-115 for the potential treatment of severe gout.
PartnersCustomers
growth-positive
Levicept Appoints Eliot Forster as CEO
Levicept Ltd, a biotech company developing a treatment for chronic pain, has announced the appointment of Eliot Forster as CEO. Founder Simon Westbrook will become CSO. Forster brings over 30 years of experience in the biotech and pharmaceutical sectors. The company is currently advancing LEVI-04, a treatment for osteoarthritis and chronic pain, through a phase II clinical trial involving over 500 patients. Forster was previously CEO of F-star, a biotech company that was acquired by inovX Pharma in March 2023. The market for drugs that modulate neurotrophins is expected to be worth over $10 billion by 2033.
Management Changes
growth-positive
PLX: More Regulatory Approvals
Protalix Biotherapeutics, Inc. announced its third quarter 2023 financial and operational results, reporting revenues of $10.3 million, a net loss of $1.9 million, and a cash balance of $41.0 million. The companys partners, Chiesi Rare Disease, Pfizer, and Fiocruz, contributed to the revenues. Protalix also announced the appointment of Dr. Eliot Richard Forster as the new Chairman of its Board of Directors. The company has been participating in investor and scientific conferences, and its partner, Chiesi Rare Disease, has been ramping up Elfabrio sales and obtaining approval in additional jurisdictions.
Management Changes
growth-positive
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q3 2023 Earnings Call Transcript
Protalix BioTherapeutics, Inc. reported its Q3 2023 earnings, beating expectations with a reported EPS of $-0.04, compared to the expected $-0.07. The company has seen no disruptions to its facilities and does not anticipate any interruption to the supply of its products Elfabrio and Elelyso. The companys commercial partner, Chiesi, has focused on the commercial launch of Elfabrio in the United States and the European Union, with additional regulatory approvals in Great Britain and Switzerland. The company is also developing its pipeline assets, including PRX-115 for the potential treatment of severe gout and PRX-119 for the potential treatment of NETs-related diseases. The company also announced a change in its board of directors.
CustomersPartnersManagement Changes
Growth-Positive
Protalix BioTherapeutics Inc (PLX) Reports Q3 2023 Financial Results
Protalix BioTherapeutics Inc reported a net income of $14.36 million for Q3 2023, a significant improvement from a loss of $11.19 million in the same period last year. Total revenue for the period stood at $55.01 million, a 41% increase from $39.02 million in Q3 2022. The companys cash and cash equivalents increased to $20.41 million from $17.11 million at the end of 2022. Protalix continues to advance its clinical trial of PRX-115, a potential treatment for severe gout, with top-line results expected in mid-2024. The company, along with its partner Chiesi Global Rare Diseases, continued to attain marketing authorizations worldwide for Elfabrio, a treatment for adult patients with Fabry disease.
Customers
growth-positive
Protalix BioTherapeutics Reports Third Quarter 2023 Financial and Business Results
Protalix BioTherapeutics, Inc. has reported its financial results for Q3 2023, showing an increase in revenues from selling goods of $10.2 million, a 16% increase compared to the same period in 2022. The company also highlighted its partnership with Chiesi Global Rare Diseases for the commercialization of Elfabrio, a drug for the treatment of adult patients with Fabry disease. Additionally, Protalix announced the appointment of Eliot Richard Forster, Ph.D. as the new Chairman of the companys Board of Directors.
CustomersPartnersManagement Changes
Neutral
Protalix BioTherapeutics to Announce Third Quarter 2023 Financial and Business Results on November 6, 2023
Protalix BioTherapeutics, Inc., a biopharmaceutical company, announced that it will release its financial results for the third quarter ended September 30, 2023, and provide a business update on Monday, November 6, 2023. The company is focused on the development, production, and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. The company has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio.
Management Changes
Neutral
Protalix BioTherapeutics Issues Statement Regarding Security Situation in Israel
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has issued a statement regarding the current security situation in Israel. The companys President and CEO, Dror Bashan, reassured employees, partners, and stockholders that the companys operations have not been adversely affected by the situation. He stated that hostilities have not taken place where Protalixs facilities are located and they do not anticipate any disruption to the supply of their products, Elfabrio and Elelyso. The company has also expressed gratitude to all partners and stockholders for their support and continued confidence in Protalix.
Partners
growth-positive
Protalix BioTherapeutics Appoints Eliot Richard Forster, Ph.D. as Chairman of its Board of Directors
Protalix BioTherapeutics, Inc. has announced the appointment of Eliot Richard Forster, Ph.D. to serve on its Board of Directors as Chairman, effective from September 14, 2023. The current Chairman, Zeev Bronfeld, will retire on the same day. Dr. Forster brings a wealth of experience in the life sciences field, with successful experience in the United States, European Union, and Asia. He currently serves as the Non-Executive Chairman of Avacta Group PLC, a Non-Executive Director of Immatics NV, and the Non-Executive Chairman of Ochre Bio, Inc.
Management Changes
growth-positive
Protalix BioTherapeutics to Present at the H.C. Wainwright 25th Annual Global Investment Conference
Protalix BioTherapeutics, a biopharmaceutical company, announced that its President and CEO, Dror Bashan, will present at the H.C. Wainwright 25th Annual Global Investment Conference on September 13, 2023. Bashan will provide a corporate overview and participate in one-on-one meetings with registered investors. Protalix focuses on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. It has licensed to Pfizer the worldwide development and commercialization rights to taliglucerase alfa for Gaucher disease treatment, excluding Brazil. Protalix has also partnered with Chiesi Farmaceutici for the global development and commercialization of Elfabrio.
Management ChangesPartners
growth-positive
PLX: Second Quarter Results
Protalix Biotherapeutics, Inc. announced its Q2 2023 financial and operational results, highlighting several positive events that have increased the companys value. These include the approval of Elfabrio by the European Commission and the FDA for marketing in the EU and US respectively, and a $20 million milestone payment from partner Chiesi. The company also reported revenues of $35.1 million for Q2 2023, a significant increase from $8.7 million in Q2 2022. This was largely due to a $20 million milestone, $11.7 million in revenues from Chiesi, and $3.4 million in revenues from Pfizer.
CustomersPartnersInvestment
growth-positive
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q2 2023 Earnings Call Transcript
Protalix BioTherapeutics, Inc. reported its Q2 2023 financial results and business updates. The company announced that the European Commission and the U.S. FDA approved Elfabrio for the treatment of adult patients with Fabry disease. This approval triggered a $20 million U.S. milestone payment from Chiesi Global Rare Diseases. The company also reported an increase in revenues from selling goods of $15.1 million during Q2 2023, an increase of $11.7 million or 344% compared to Q2 2022. The company is also making progress on PRX-115 and PRX-119, drugs in development for the treatment of severe gout and NETs-related diseases respectively.
CustomersPartnersInvestment
growth-positive
Protalix BioTherapeutics Reports Second Quarter 2023 Financial and Business Results
Protalix BioTherapeutics, Inc. has reported its financial results for Q2 2023, highlighting a transformational year with significant regulatory approvals for its drug Elfabrio in the US and EU. The companys commercial partner, Chiesi Global Rare Diseases, has launched the product in the US. Protalix also announced that it is eligible to receive a $20 million milestone payment from Chiesi following the FDAs approval of Elfabrio. The company recorded revenues from selling goods of $15.1 million during Q2 2023, an increase of 344% compared to the same period in 2022.
CustomersPartnersInvestment
growth-positive
Protalix BioTherapeutics to Present at the Canaccord Genuity 43rd Annual Growth Conference
Protalix BioTherapeutics, Inc. announced that its President and CEO, Dror Bashan, will present at the Canaccord Genuity 43rd Annual Growth Conference on August 9, 2023. The companys management will also participate in one-on-one meetings with registered investors. A live and archived webcast of the presentation will be available. The company is focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. It has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, excluding in Brazil, where Protalix retains full rights.
Management Changes
Neutral
Protalix BioTherapeutics to Announce Second Quarter 2023 Financial and Business Results on August 7, 2023
Protalix BioTherapeutics, Inc., a biopharmaceutical company, has announced that it will release its financial results for the second quarter ended June 30, 2023, and provide a business update on Monday, August 7, 2023. The company will host a conference call and webcast to discuss the financial results and provide an update on recent corporate and regulatory developments. Protalix is focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system. It has partnered with Pfizer Inc. and Chiesi Farmaceutici S.p.A. for the global development and commercialization of its products.
growth-positive
Protalix BioTherapeutics to Host In-Person KOL Breakfast following the Approval of Elfabrio® in both the United States and the European Union for Adults with Fabry Disease
Protalix BioTherapeutics, Inc. will host an in-person KOL breakfast in New York to discuss the recent FDA approval of Elfabrio for the treatment of Fabry disease. The event will feature presentations by medical professionals and the companys commercial partner. The companys leadership will also provide insight into the companys strategy and future plans. The event will include a live question and answer session. Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins.
Partners
growth-positive
Protalix BioTherapeutics Issues Letter to Stockholders
Protalix BioTherapeutics, Inc. has announced the approval of its primary development candidate, Elfabrio, for the treatment of Fabry disease in the US and EU. This marks a significant milestone for the company and demonstrates its commitment to delivering innovative solutions to patients. Elfabrio is the second therapy based on Protalixs proprietary ProCellEx plant cell-based protein expression system. The companys commercial partner for Elfabrio, Chiesi Global Rare Diseases, is prepared for a successful commercial launch. Protalix is now focusing on its pipeline programs for future growth and plans to share insights and strategic initiatives at an upcoming investors event. The company expresses gratitude to its stockholders for their continued support and commitment to creating value for investors and patients.
CustomersPartners
growth-positive
PLX: Back of the Envelope
Protalix Biotherapeutics has received FDA approval and European Commission approval for its product Elfabrio. The company also announced a $20 million milestone payment from commercialization partner Chiesi. In addition, Protalix will be included in the Russell 3000 Index. These positive developments have not been reflected in the companys share price, which has remained low. A conservative valuation analysis suggests a significantly higher valuation for Protalix. The companys target price is $16 per share. Protalix is expected to hold an investor day in June to discuss its development candidates and Chiesis commercialization efforts. The companys future looks promising, with ongoing clinical trials and potential market share gains for Elfabrio.
CustomersPartnersInvestment
growth-positive
Protalix BioTherapeutics set to join Russell 3000® Index
Protalix BioTherapeutics, Inc. is set to join the broad-market Russell 3000 Index, which is a growth-positive impact on the company. The key theme of the article is the inclusion of Protalix in the Russell U.S. Indexes, which is seen as a milestone in the companys progress. The article discusses the approval of PRX–102 for the treatment of Fabry disease and the focus on product candidates in Protalixs pipeline. The structured issue is Public Trading, as the company will be included in the Russell 3000 Index. The event described in the article is set to happen on June 26, 2023. The confidence level of the answer is 8.
Public Trading
growth-positive
Protalix BioTherapeutics Announces $20 Million Milestone Payment from Chiesi Global Rare Diseases
Protalix BioTherapeutics is eligible to receive a $20 million milestone payment from its commercial partner, Chiesi Global Rare Diseases, triggered by the FDA approval of ELFABRIO for the treatment of Fabry disease. The payment will strengthen Protalixs financial position. Protalix has already received a total of $95.0 million in upfront payments and to cover development costs from Chiesi. The company is entitled to up to $1.0 billion in potential milestone payments and royalties as consideration for product supply. On a proforma basis, including the milestone payment, Protalixs cash and cash equivalents as of May 18, 2023, is $51.6 million.
Partners
growth-positive
PLX: FDA Approval of Elfabrio
The FDA has granted approval to Protalix Biotherapeutics drug Elfabrio for the treatment of Fabry disease. This marks the companys 15th approved drug for the year. The European Medicines Agency has also provided authorization for the product. Protalixs valuation has been updated to reflect the approval, with a price target of $16.00 per share. The company is now focusing on its development assets, including PRX-115, PRX-102, and PRX-119. Protalix has started the Phase I clinical trial for PRX-115 and has submitted its BLA and MAA for PRX-102 to regulatory authorities. An investor day is planned for June 2023 to discuss the companys strategy. The approval of Elfabrio provides a new treatment option for around 15,000 Fabry patients in the associated regions.
Customers
Fabry Disease Treatment Showdown: Protalix Bio's Elfabrio Joins the Ranks of Sanofi and Amicus Therapeutics
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce FDA Approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease
growth-positive
FDA Approves Fabry Disease Treatment from Chiesi, Protalix | BioSpace
The FDA has approved Elfabrio, a treatment for adult patients with Fabry disease, developed by Chiesi Global Rare Diseases and Protalix BioTherapeutics. Elfabrio is an enzyme replacement therapy that works by restoring the bodys ability to degrade a fatty substance that accumulates in patients with Fabry disease. The approval comes after a comprehensive clinical development program involving over 140 patients and several clinical trials. The treatment may cause hypersensitivity reactions and other side effects, and the FDA recommends having medical support measures on standby when administering it.
Partners
Weekly biotech pulse: Big catalysts on tap for Sarepta, Roche, Eyenovia, and more
PLX: One Down, One to Go
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease
growth-negative
Protalix BioTherapeutics Reports First Quarter 2023 Financial and Business Results
Protalix BioTherapeutics, Inc. reported its financial results for Q1 2023, showing a decrease in revenues from selling goods and license and R&D services compared to the same period in 2022. The company also provided updates on its clinical and corporate developments, including progress in its PRX–115 program for severe gout and awaiting decisions from the European Commission and the U.S. FDA. Protalix and its partner, Chiesi, remain committed to bringing PRX-102 to market for patients with Fabry disease. The company also announced the voluntary delisting of its common stock from the Tel Aviv Stock Exchange.
CustomersPartners
growth-positive
Protalix BioTherapeutics to Announce First Quarter 2023 Financial and Business Results on May 4, 2023
Protalix BioTherapeutics, Inc. will release its financial results for the first quarter of 2023 and provide a business update on May 4, 2023. The company will host a conference call with investors to discuss the financial results and recent corporate and regulatory developments. The conference call will be webcast live from the companys website. Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system.
Investment
growth-positive
Protalix BioTherapeutics Announces First Patient Dosed in First in Human Phase I Clinical Trial of PRX-115 for the Treatment of Severe Gout
Protalix BioTherapeutics has announced the initiation of a phase I clinical trial for PRX-115, a recombinant PEGylated uricase product candidate for the treatment of severe gout. The trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of PRX-115 in patients with elevated uric acid levels. The trial is being conducted in New Zealand and is expected to enroll approximately 56 patients. Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell–based protein expression system.
Investment
growth-neutral
Protalix BioTherapeutics Issues Statement Related to Silicon Valley Bank and Signature Bank
Protalix BioTherapeutics, Inc. announced that it does not hold cash deposits or securities at Silicon Valley Bank or Signature Bank, and it does not have any financial relationship with either institution. The closure of these banks is not expected to have any impact on the companys operations. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced through its proprietary plant cell-based expression system, ProCellEx.
Partners
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q4 2022 Earnings Call Transcript
PLX: May is a Big Month
growth-positive
Protalix BioTherapeutics Reports Fiscal Year 2022 Financial and Business Results
Protalix BioTherapeutics, Inc. reported its financial results for the fiscal year ended December 31, 2022, and provided a business update. The company recorded revenues from selling goods of $25.3 million, an increase of 51% compared to the previous year. The company also announced regulatory advancements, including the European Medicines Agencys positive opinion recommending marketing authorization for PRX–102 for adult patients with Fabry disease. The company also announced clinical advancements and corporate developments, including the appointment of a new member to the Board of Directors.
CustomersPartners
Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease
growth-positive
Protalix BioTherapeutics to Participate in the 19th Annual WORLDSymposium™ 2023
Protalix BioTherapeutics, Inc. will be participating in the 19th Annual WORLDSymposium™ 2023. The company will be hosting an informational booth at the symposium, while its commercialization partner, Chiesi Global Rare Diseases, will also be participating and presenting on PRX-102 and Fabry disease. Protalix BioTherapeutics focuses on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® system. The companys first product, taliglucerase alfa, was approved by the FDA in 2012. Protalix has licensed the development and commercialization rights for taliglucerase alfa to Pfizer Inc. The company has a development pipeline of other product candidates and has partnered with Chiesi Farmaceutici for the development and commercialization of pegunigalsidase alfa.
PartnersCustomers
growth-negative
Protalix BioTherapeutics to Delist its Common Stock from the Tel Aviv Stock Exchange
Protalix BioTherapeutics has announced its decision to voluntarily delist its common stock from the Tel Aviv Stock Exchange (TASE). The company believes that focusing on a single exchange will be in the best interest of the company and its stockholders, allowing for better market activity concentration and reduced operational costs. The delisting process is expected to take three months. However, trading of the companys common stock on the NYSE American will be unaffected. Protalix BioTherapeutics will continue to file public reports and disclosures in accordance with US regulations. The companys common stock traded on the TASE is expected to transfer to the NYSE American once the delisting becomes effective.
Public Trading
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of a Resubmitted Biologics License Application for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The FDA set an action date of May 9, 2023, for the BLA. The resubmission includes comprehensive clinical and manufacturing data. Protalix will be eligible to receive a milestone payment from Chiesi if the drug is approved. Fabry disease is an X-linked inherited disease that results in the accumulation of abnormal deposits in blood vessel walls. PRX-102 is an investigational enzyme replacement therapy for Fabry disease.
Customers
growth-positive
Protalix BioTherapeutics to Present in Person at the H.C. Wainwright 24th Annual Global Investment Conference
Protalix BioTherapeutics, Inc. announced that its President and CEO will present at the H.C. Wainwright 24th Annual Global Investment Conference. The live presentation will replace the pre-recorded presentation previously announced. The companys management will also participate in one-on-one meetings with investors at the conference. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based expression system.
InvestmentPartners
growth-positive
Protalix BioTherapeutics Reports Second Quarter 2022 Financial and Business Results
Protalix BioTherapeutics, Inc. has reported its financial results for Q2 2022, revealing an increase in revenues from selling goods and licenses and R&D services. The company also announced positive topline results from its phase III BALANCE clinical trial of PRX-102 for the treatment of adult patients with Fabry disease. Additionally, the company appointed Shmuel Muli Ben Zvi, Ph.D. to the Board of Directors. Despite the positive developments, the company reported a net loss of approximately $5.3 million for the quarter.
Management ChangesInvestment
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Topline Results from the 24-Month Phase III BALANCE Clinical Trial of PRX-102 for the Treatment of Fabry Disease
Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases have announced positive topline results from the BALANCE pivotal Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102) for the treatment of Fabry disease. The study met its pre-specified primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta. The companies plan to work with regulatory agencies on the applicable submissions, potentially bringing PRX–102 to approval as a new PEGylated enzyme replacement therapy for all adult Fabry patients.
Partners
growth-positive
Protalix BioTherapeutics Reports Fiscal Year 2021 Financial and Business Results
Protalix BioTherapeutics, Inc. has reported its financial results for the fiscal year ended December 31, 2021, and provided a business update on recent corporate and clinical developments. The company has made significant progress towards its key operational, clinical, and regulatory goals in 2021. It has also strengthened its balance sheet through exchanges of a substantial majority of its then outstanding 7.50% Senior Secured Convertible Notes due 2021 for a combination of cash and new notes. The company has also entered into a Sales Agreement with H.C. Wainwright & Co., LLC, as sales agent, pursuant to which the company may sell from time to time up to $20.0 million worth of shares of its common stock in at-the-market transactions through the Agent.
InvestmentPartners
growth-positive
Protalix BioTherapeutics Reports Third Quarter 2021 Financial Results and Provides Financial and Business Update
Protalix BioTherapeutics, Inc. has reported its financial results for Q3 2021 and provided updates on recent corporate, clinical, and regulatory developments. The company has made progress with the regulatory path for PRX-102 for the treatment of Fabry disease with both the U.S. Food and Drug Administration and the European Medicines Agency. The company has also completed a note exchange agreement in August, providing additional financial flexibility and sufficient capital to fund operations through important milestones in 2022. The company has also partnered with Chiesi Farmaceutici S.p.A. for the development and commercialization of PRX-102.
InvestmentPartners
growth-positive
Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease
Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., have provided an update on the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease. The BALANCE study is ongoing and assignment to treatment arm remains blinded. Based on the interim analysis of the 12-month data generated from the BALANCE study, and in combination with previously reported positive data from the Phase III BRIGHT and BRIDGE clinical trials of PRX–102, Protalix and Chiesi intend to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of PRX–102 for the proposed treatment of Fabry disease.
PartnersExpand
growth-negative
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Protalix BioTherapeutics and Chiesi Global Rare Diseases received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for the proposed treatment of Fabry disease. The CRL is a setback for the company, but they remain confident in the strength of their data and program. Protalix and Chiesi are studying the CRL to determine the best regulatory approach to obtain approval for PRX-102. Fabry disease is an X-linked inherited disease that causes the accumulation of abnormal deposits in the body. The PRX-102 BLA was initially submitted for accelerated approval and was granted Priority Review by the FDA. Protalixs development pipeline includes other product candidates for various diseases. Chiesi provides access to pegunigalsidase alfa through its Expanded Access Program for Fabry disease patients.
Customers
growth-negative
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Protalix BioTherapeutics and Chiesi Global Rare Diseases received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for the proposed treatment of Fabry disease. The CRL is a setback for the company, but they remain confident in the strength of their data and program. Protalix and Chiesi are studying the CRL to determine the best regulatory approach to obtain approval. Fabry disease is an X-linked inherited disease that causes the accumulation of abnormal deposits in the body. The PRX-102 BLA was initially submitted for accelerated approval and was granted Priority Review by the FDA. Protalixs development pipeline includes other product candidates for various diseases. Chiesi provides access to pegunigalsidase alfa through its Expanded Access Program for Fabry disease patients.
Customers
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Positive Topline Results from BRIGHT Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa 2 mg/kg every Four Weeks for Treatment of Fabry Disease
Protalix BioTherapeutics and Chiesi Global Rare Diseases have announced positive results from the BRIGHT Phase III clinical trial of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. The trial found that 2 mg/kg of PRX-102 administered every four weeks was well tolerated among patients, and stable clinical presentation was maintained in adult Fabry patients. No new patients developed treatment-induced anti-drug antibodies following the switch to PRX-102 treatment. The companies plan to report final data on the BRIGHT study in the second half of 2021.
Partners
growth-positive
Protalix BioTherapeutics Completes Raise of Approximately $40 Million in Gross Proceeds
Protalix BioTherapeutics has completed a fundraising round, raising approximately $40 million in gross proceeds. The company plans to use the funds to support clinical trials for its product candidates, as well as for research and development activities and general corporate purposes. The fundraising round involved the participation of new institutional investors, which will help strengthen Protalixs balance sheet and accelerate clinical trial development. The company is focused on the development and commercialization of recombinant therapeutic proteins using its proprietary plant cell-based expression system. Protalix has a pipeline of product candidates and is preparing for a potential commercial launch in a significant market.
Investment
growth-positive
Protalix BioTherapeutics Enters into an Exclusive Partnership with SarcoMed USA to Develop alidornase alfa for the Treatment of Pulmonary Sarcoidosis and Related Respiratory Diseases Via Inhaled Delivery
Protalix BioTherapeutics has announced an exclusive worldwide license agreement with SarcoMed USA for alidornase alfa, a treatment for respiratory diseases. SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, as well as clinical research and development. Protalix will receive an initial cash payment of $3.5 million, with additional milestone payments and royalties on net sales. The agreement validates Protalixs development pipeline of drug candidates produced through its ProCellEx system. Alidornase alfa has received Orphan Drug Designation from the FDA for the treatment of sarcoidosis. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins.
Partners
growth-positive
Protalix BioTherapeutics Announces Proposed Public Offering of Common Stock
Protalix BioTherapeutics, Inc. plans to make a public offer of 6,500,000 shares of its common stock. The company intends to use the net proceeds from the offering to fund clinical trials for its product candidates, research and development activities, and for working capital and general corporate purposes. The offering is being made pursuant to an effective shelf registration statement. BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering.
Investment
growth-positive
Protalix BioTherapeutics Issues 2020 Letter to Shareholders
Protalix BioTherapeutics, Inc. has announced its accomplishments in 2020, including the submission of a Biologics License Application (BLA) for PRX-102 for the treatment of Fabry disease. The company has also strengthened its financial foundation, advanced its pipeline of candidates, and sought collaborative partnerships. Protalix expects the FDA to make a decision on the BLA by April 27, 2021. The company has completed two studies for PRX-102 and expects to release topline data from a third study in the first quarter of 2021. Protalix has also entered into a non-binding term sheet with SarcoMed USA Inc. for the development and commercialization of PRX-110. The company raised approximately $44 million in a private placement and established an at-the-market offering to raise up to $30 million. Protalix has enhanced its management team with the appointment of a new Vice President of Research and Development.
PartnersInvestmentManagement Changes
growth-negative
FDA Extends Review Date to April for US Approval of PRX-102
The U.S. Food and Drug Administration (FDA) has extended the review date for Protalix BioTherapeutics biologics license application (BLA) for PRX-102, an enzyme replacement therapy for Fabry disease. The FDAs accelerated approval pathway program allows medications that address an unmet need to rapidly obtain conditional approval. The new review date is April 27, 2021. PRX-102 is a stabilized version of a man-made form of alpha-galactosidase A and requires less frequent infusions than existing enzyme replacement therapies. The BLA submission included data from clinical trials showing the effectiveness of PRX-102 in decreasing disease biomarkers, improving kidney function, and slowing disease progression. The FDA had already granted PRX-102 priority review designation.
Customers
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced that the FDA has extended the review date for Protalixs Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa for the treatment of Fabry disease. The FDA extended the PDUFA action date by three months to April 27, 2021. The BLA submission includes data from clinical trials and manufacturing data. Protalix BioTherapeutics is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins.
Customers
growth-positive
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Launch of Expanded Access Program in the United States for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases have announced the launch of an Expanded Access Program (EAP) in the United States for pegunigalsidase alfa, a proposed treatment for Fabry disease. The EAP will run concurrently with Protalixs ongoing Phase III clinical program. The program will provide access to pegunigalsidase alfa for patients with Fabry disease who have no comparable or satisfactory alternative treatment options. The EAP is open to eligible patients who will receive infusions of pegunigalsidase alfa every two weeks. The launch of the EAP demonstrates the commitment of Chiesi and Protalix to support patients with Fabry disease. Pegunigalsidase alfa is currently under review by the U.S. Food and Drug Administration (FDA).
Customers
growth-positive
Protalix BioTherapeutics Regains Compliance with NYSE American Continued Listing Standards
Protalix BioTherapeutics has regained compliance with all of the continued listing standards set forth by the NYSE American. The company had previously received a deficiency letter stating that it was not in compliance with the standards. However, through its efforts, Protalix has resolved the deficiency and regained compliance. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based expression system. The companys first product, taliglucerase alfa, was approved by the FDA in 2012, and it has also developed pegunigalsidase alfa for the treatment of Fabry disease. Protalix has partnered with Chiesi Farmaceutici for the development and commercialization of pegunigalsidase alfa. The companys development pipeline includes other proprietary versions of recombinant therapeutic proteins.
Public Trading
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of Biologics License Application (BLA) for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease and Grants Priority Review
Protalix BioTherapeutics, Inc. and its partner Chiesi Global Rare Diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The FDA set an action date of January 27, 2021, for the review. This development represents a significant achievement for Protalix and Chiesi as they aim to establish a new treatment option for the Fabry patient community. Fabry disease is an X-linked inherited disease that results in the progressive accumulation of abnormal deposits in blood vessel walls. Pegunigalsidase alfa is an investigational product candidate designed to address the unmet clinical need in Fabry patients.
Customers
growth-positive
Protalix BioTherapeutics Appoints Yael Hayon, Ph.D. as its New Vice President, Research and Development
Protalix BioTherapeutics has announced the appointment of Yael Hayon, Ph.D. as the new Vice President of Research and Development, effective July 5, 2020. Yoseph Shaaltiel, Ph.D. has retired from his position as the Executive Vice President of Research and Development. The company expressed gratitude to Shaaltiel for his contributions in founding and building Protalix. Dr. Hayon brings over a decade of experience in pharmaceutical research and development. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins. They use a proprietary plant cell-based expression system called ProCellEx. Their first product, taliglucerase alfa, was approved by the FDA in 2012 and they have licensed the development and commercialization rights to Pfizer Inc. for this product.
Management Changes
growth-positive
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Submission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease
Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the treatment of adult patients with Fabry disease. The submission includes data from clinical trials and studies of PRX-102. If approved, Protalix will receive a milestone payment from Chiesi. The submission represents a significant milestone for Chiesi Global Rare Diseases, which was established earlier this year to focus on rare diseases. The partnership between Protalix and Chiesi aims to bring new treatment options to patients with Fabry disease and other rare diseases.
PartnersCustomers
growth-positive
Protalix BioTherapeutics Raises $43.7M in Financing - FinSMEs
Protalix BioTherapeutics has raised $43.7 million in financing through a private equity investment. The funds will be used to advance the companys clinical programs and commercialization of PRX-102 for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system. The company has licensed the worldwide development and commercialization rights for taliglucerase alfa to Pfizer Inc. and has partnered with Chiesi Farmaceutici for the development and commercialization of pegunigalsidase alfa.
Investment
growth-positive
Protalix BioTherapeutics and Chiesi Farmaceutici Announce Receipt of "Agreement Letter" for Initial Pediatric Study Plan for PRX-102 for the Treatment of Fabry Disease
Protalix BioTherapeutics and Chiesi Farmaceutici have announced an agreement with the U.S. Food and Drug Administration (FDA) for the Initial Pediatric Study Plan (iPSP) for PRX-102, a treatment for Fabry disease. The agreement marks an important milestone for Protalix in bringing a new treatment option to the Fabry patient community. The companies expect to submit a Biologics License Application (BLA) to the FDA under an Accelerated Approval pathway. Fabry disease is an X-linked inherited disease that results in the progressive accumulation of abnormal deposits in blood vessel walls. PRX-102 has the potential to be approved for adult patients with Fabry disease. Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins.
Partners
growth-positive
Protalix BioTherapeutics Adds Two Accomplished Biopharmaceutical Executives to its Board of Directors
Protalix BioTherapeutics has announced the appointment of Pol F. Boudes, MD, and Gwen A. Melincoff to its Board of Directors. The new appointments will expand the size of the Board from five to seven directors. Pol Boudes brings over 25 years of experience in medical research and development, with a special emphasis on orphan drugs and translational medicine. Gwen Melincoff has over 25 years of business development and venture capital leadership experience in the biotechnology and pharmaceutical industries. Protalix expects their valuable insights and contributions to guide the company forward as it continues to advance its clinical pipeline towards commercialization.
Management Changes
growth-positive
Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Protalix BioTherapeutics and Chiesi Farmaceutici have completed a successful meeting with the FDA regarding the Accelerated Approval pathway for pegunigalsidase alfa (PRX‑102) for the treatment of Fabry disease. The FDA has confirmed the proposed BLA submission and the alignment on the Accelerated Approval pathway. The BLA, expected to be submitted by April 2020, will include data from completed and ongoing clinical trials. The ongoing BALANCE study will serve as the confirmatory trial for PRX‑102. The FDA indicated that no additional clinical trials will be required. Protalix and Chiesi expect to bring an approved product to market to help Fabry patients. The companys pipeline also includes other product candidates for various diseases.
InvestmentPartners
growth-positive
Protalix up 74% after positive Fabry disease trial results
Protalix Biotherapeutics Inc. has announced positive 12-month on-treatment data from its BRIDGE Phase III study. The results suggest a strong potential benefit of pegunigalsidase alfa on renal function for Fabry patients. The interim data from the first 16 adult patients enrolled demonstrate a mean improvement in kidney function when switched from agalsidase alfa to pegunigalsidase alfa.
Customers
growth-positive
Protalix BioTherapeutics and Chiesi Group Complete Enrollment in the Third Phase III Clinical Trial of pegunigalsidase alfa (PRX‑102) for the Treatment of Fabry Disease
Protalix BioTherapeutics, Inc., a biopharmaceutical company, and its partner, Chiesi Farmaceutici S.p.A., have announced the completion of enrollment in their Phase III BALANCE clinical study of pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease. The study is designed to evaluate the safety and efficacy of PRX-102 compared to agalsidase beta on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. The company is targeting a BLA submission under an accelerated approval pathway for PRX-102 in the first quarter of 2020.
Partners
growth-positive
Protalix BioTherapeutics Focuses on Evaluating and Pursuing Alternatives to Maximize Shareholder Value through Refinancing & Strategic Partnerships
Protalix BioTherapeutics has engaged a financial advisory firm to evaluate strategic alternatives and maximize stakeholder value. The company is actively pursuing potential partnerships for its pipeline candidates and its ProCellEx platform. Protalixs unique expression system allows for cost-effective development of recombinant proteins. The companys first product, taliglucerase alfa, was approved by the FDA in 2012. Protalix has licensed the worldwide development and commercialization rights for taliglucerase alfa to Pfizer, excluding Brazil. The companys pipeline includes pegunigalsidase alfa, OPRX-106, alidornase alfa, and others. Protalix has partnered with Chiesi Farmaceutici for the development and commercialization of pegunigalsidase alfa. The company aims to improve its capital structure, pursue strategic partnerships, and move its pipeline towards commercialization.
PartnersExpand
growth-negative
Shlomo Yanai Resigns as Chairman of the Board of Protalix BioTherapeutics
Shlomo Yanai has resigned from Protalix BioTherapeutics Board of Directors for personal reasons. Zeev Bronfeld, a current independent director, has been elected as the new Chairman of the Board. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins.
Management Changes
growth-positive
Protalix BioTherapeutics Appoints Eyal Rubin as its New Senior Vice President and Chief Financial Officer
Protalix BioTherapeutics has announced the appointment of Eyal Rubin as the new Senior Vice President and Chief Financial Officer. Rubin will assume the role on September 22, 2019, and will bring over 20 years of finance and capital markets experience to the company. He most recently served as the Executive Vice President and CFO of BrainStorm Cell Therapeutics Inc. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins. The companys first product, taliglucerase alfa, was approved by the FDA in 2012 and Protalix has licensed the worldwide development and commercialization rights to Pfizer Inc.
Management Changes
growth-positive
Protalix BioTherapeutics Completes Enrollment in the Phase III BRIGHT Clinical Trial of pegunigalsidase alfa (PRX 102) for the Treatment of Fabry Disease
Protalix BioTherapeutics has announced the completion of enrollment in the phase III BRIGHT clinical trial of pegunigalsidase alfa for the treatment of Fabry disease. The trial is assessing the safety, efficacy, and pharmacokinetics of the drug candidate, which has the potential to double the time between infusions for patients with Fabry disease. The completion of enrollment marks a key milestone for the company, as it has the potential to greatly enhance the quality of life for some patients. Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins.
Customers
growth-positive
Protalix BioTherapeutics and Chiesi Farmaceutici S.p.A to Apply for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Protalix BioTherapeutics and Chiesi Farmaceutici plan to file a biologics license application (BLA) for pegunigalsidase alfa for the treatment of Fabry disease in the first quarter of 2020. The BLA will be submitted via the FDAs Accelerated Approval pathway. If approved, Protalix will be eligible to receive a milestone payment from Chiesi. The company remains optimistic about the FDAs approval of pegunigalsidase alfa on an accelerated basis.
Investment
growth-negative
Protalix BioTherapeutics Appoints Dror Bashan as its New President and Chief Executive Officer and Director
Protalix BioTherapeutics, Inc. has announced the appointment of Dror Bashan as the new President and CEO, effective June 30, 2019. Bashan will replace Moshe Manor, who is stepping down for personal reasons. Manor will assist with the transition and continue to work with the company on a consultant basis. Bashan brings valuable experience and knowledge in the pharmaceutical industry to Protalix. He has over 20 years of experience in various senior positions at Teva Pharmaceutical Industries. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins. Their first product, taliglucerase alfa, was approved by the FDA in 2012. Protalixs development pipeline includes other product candidates such as pegunigalsidase alfa and alidornase alfa.
Management Changes
growth-positive
Protalix BioTherapeutics Enters into an Exclusive Ex-US Partnership with Chiesi Farmaceutici for the Development and Commercialization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease
Protalix BioTherapeutics has entered into an Ex-US license and collaboration agreement with Chiesi Farmaceutici for PRX-102, a chemically modified version of the recombinant protein alpha-Galactosidase-A protein. Under the agreement, Protalix will receive $25 million upfront, up to $25 million in development costs, and up to $320 million in potential regulatory and commercial milestone payments. Protalix will also receive tiered royalties ranging from 15% to 35% on net sales. The agreement allows Protalix to secure significant funding while maintaining full rights to PRX-102 in the U.S. market. Chiesi is an international pharmaceutical company with a focus on the development and commercialization of innovative medicines. PRX-102 is being evaluated in phase III clinical trials for the treatment of Fabry disease.
Partners
growth-positive
Pfizer Invests $10M In Protalix, Pays $36M For Commercial Rights
Pharma giant Pfizer has invested $10 million in Protalix Biotherapeutics and acquired full commercial rights to the Gaucher disease treatment Elelyso, except in Brazil, in exchange for $36 million cash. Protalix has undergone management changes and a new business strategy under the leadership of CEO Moshe Manor. The Israeli bio-medical company was founded by Yoseph Shaaltiel in 1993.
InvestmentPartners
N/A
Protalix flips its Gaucher drug to Pfizer for $46M in R&D cash
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Protalix BioTherapeutics Team
Employee Info
| Employees (range) | 51-200 |
| Exact count | 194 |
| Team members | 6 |
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Protalix BioTherapeutics Internal
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Admin Info
| Confidence | 91/100 |
| Missing | markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 511903288 |
| Crunchbase | protalix-biotherapeutics |
| Phone | +97249028100 |
| Creator | Rebecca Mack |
| Creator email | rebeccamack26@gmail.com |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2024-03-18T00:00:00.000Z |
| Created | 2014-07-29T00:00:00.000Z |
| Status detail | Public on AMEX on Dec, 2006;Public on TASE on Nov, 2010;Public on NYSE on Mar, 2011; |