Prilenia Therapeutics News
11 articles
Growth-Positive
Prilenia to seek European approval of pridopidine for Huntington's
Prilenia Therapeutics is planning to submit a marketing authorization application (MAA) for the approval of pridopidine, a treatment for Huntingtons disease, in the European Union. The filing follows positive discussions at pre-submission meetings with the Committee for Medicinal Products for Human Use, part of the European Medicines Agency (EMA). If approved, the therapy could be available to patients as early as 2025. Prilenia also plans to discuss potential approval in the U.S. with the Food and Drug Administration and consider filing for approval in other countries following the EMAs review.
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growth-positive
Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS
Prilenia Therapeutics B.V., a clinical stage biotechnology company, is planning to start a pivotal Phase 3 study in H2 2024 for the development of pridopidine, a potential treatment for amyotrophic lateral sclerosis (ALS) and Huntington’s disease. The company has completed discussions with global regulatory agencies regarding the next stage of development of pridopidine for ALS. The company is backed by a group of investors including Forbion, Morningside, Sands Capital, SV Health Investors, Sectoral Asset Management, Talisman, Amplitude Ventures and the ALS Investment Fund.
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growth-positive
New EAP will allow pridopidine use for ALS patients not in trial |...
Prilenia Therapeutics is set to provide its experimental ALS treatment, pridopidine, to patients not eligible for clinical trials through an expanded access program (EAP). The EAP, funded by a grant from the National Institute of Neurological Disorders and Stroke and supported by the Accelerating Access to Critical Therapies for ALS act, will enroll about 200 patients across 45 centers in the U.S. The program will provide real-world safety, biomarker, and clinical data on the effects of pridopidine in a broad population. Despite failing to meet its primary goal in Phase 2/3 trials, pridopidine showed significant benefits in certain speech measures and positive trends in respiratory function.
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growth-positive
Prilenia announces publication of data elucidating a mechanism for neuroprotective potential of pridopidine
Prilenia Therapeutics B.V. has published research in the peer-reviewed journal Autophagy, highlighting the potential neuroprotective properties of pridopidine in an amyotrophic lateral sclerosis (ALS) model. Pridopidine, an oral Sigma-1 Receptor agonist, is currently in late-stage development for the treatment of Huntingtons disease (HD) and ALS. The research shows that pridopidine enhances autophagy, a cellular process critical to preserving neuronal health, and may reduce toxic protein aggregation associated with neurodegenerative diseases. The study also reveals the role of pridopidines mechanism of action in activating the S1R and facilitating the translocation of TFEB into the nucleus, leading to neuroprotection. Prilenia is focused on developing novel therapeutics for neurodegenerative and neurodevelopmental disorders and has received Fast Track designation for pridopidine for the treatment of HD. The company is backed by a group of investors including Forbion, Morningside, Sands Capital, SV Health Investors, Sectoral Asset Management, Talisman, Amplitude Ventures, and the ALS Investment Fund.
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SV Health Investors Joins Prilenia Series B as the Company Prepares for ALS and HD Data Readouts in the Next 12 Months
growth-positive
Prilenia Therapeutics Raises $43M in Series B Funding - FinSMEs
Prilenia Therapeutics, a biotech company, has raised $43M in Series B funding. The funding brings the total capital raised since its founding to $133.5M. The company plans to use the funds to prepare for potential registration and commercialization of its lead drug candidate, pridopidine, for patients with Huntingtons Disease and Amyotrophic Lateral Sclerosis. Pridopidine is a Phase 3 clinical stage drug candidate that is being assessed for the treatment of HD and ALS. The funding round was led by Sands Capital with participation from Forbion and Morningside, among others.
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Prilenia Enrolls First Subject in Europe in its PROOF-HD Phase 3 Clinical Trial for Huntington's Disease
Prilenia Announces First Patient Enrolled for Pridopidine Phase 2/3 Platform Trial for ALS
Prilenia Enrolls First Patients Into its PROOF-HD Phase 3 Clinical Trial for Huntington's Disease in the United States
growth-positive
Prilenia Therapeutics raises $62.5m, names Michael Hayden CEO
Prilenia Therapeutics, a clinical stage biotech company, has raised $62.5 million in a Series A financing round. The funds will be used for two late-stage trials of pridopidine for the treatment of Huntingtons Disease (HD) and Amyotrophic Lateral Sclerosis (ALS). The company has also appointed Dr. Michael R. Hayden as CEO. The trials are expected to commence in the second half of 2020. Prilenia has raised a total of $84.5 million since its founding in 2018.
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Prilenia's Pridopidine Chosen to Participate in the First ALS Platform Trial
