Articles from Prilenia Therapeutics B.V.

Prilenia Therapeutics B.V. and Ferreri today announced initiation of the confirmatory PRECISE-HD study (Pridopidine Phase 3 Study to Establish Clinical Impact and Safety in Huntington’s Disease (HD) (NCT07609108)). Recruitment has now commenced in the US, with other countries expected to follow on a rolling basis later in the year.

Prilenia Therapeutics B.V. today announced a Data Use Agreement (DUA) under which Prilenia will provide CHDI with clinical data from the placebo arms of its PRIDE and PROOF studies for the purpose of advancing research into treatments for Huntington's disease (HD).

Prilenia Therapeutics B.V., a biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD) and Amyotrophic Lateral Sclerosis (ALS), today announced the appointment of Elisabeth (Lis) Leiderman, MD, MBA, as Chief Financial Officer.

Prilenia Therapeutics B.V. and Ferrerii today announced the first enrollment in the pivotal, 500-participant, randomized, placebo-controlled Phase 3 study of pridopidine in people with rapidly progressive Amyotrophic Lateral Sclerosis (ALS) early in their disease course (“PREVAiLS”, NCT07322003).

Prilenia Therapeutics B.V. and Ferrer today announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, randomized, placebo-controlled Phase 3 study of pridopidine in participants with rapidly progressive amyotrophic lateral sclerosis (ALS) early in their disease course. Recruitment is planned to begin at the first US clinical trial sites in early 2026, with sites in Europe and other regions to follow, pending local clinical trial clearance.

Prilenia Therapeutics B.V. and Ferrer today announced the presentation of five posters outlining slowing of clinical progression and additional pridopidine data at the 2025 HSG HD Clinical Research Congress, 10-13 October, 2025.

Prilenia Therapeutics B.V. and Ferrer today announced the presentation of their planned pivotal Phase 3 study of pridopidine in Amyotrophic Lateral Sclerosis (ALS) at the upcoming Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2025 Annual Meeting, Florida, October 7-10, 2025.

Prilenia Therapeutics B.V. and Ferrer today announced the publication, in the journal Nature Medicine, of a manuscript entitled "Pridopidine in Early-Stage Manifest Huntington Disease: A Phase 3 Trial"ii. The publication describes data showing that treatment with pridopidine slowed clinical progression in Huntington’s disease (HD) patients not taking antidopaminergic medicines (ADMs).

Prilenia Therapeutics B.V. and Ferrer today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorization for pridopidine’s marketing authorization application for Huntington’s disease (HD).

Prilenia Therapeutics B.V., a biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS), today announced that it has entered into a collaboration and license agreement with Ferrer for the commercialization and further development of pridopidine in Europe and other select markets. Pridopidine is a potent and highly selective, orally administered sigma-1 receptor (S1R) agonist designed to regulate key neuroprotective mechanisms often impaired in neurodegenerative diseases such as HD and ALS.

Prilenia Therapeutics B.V., a biopharmaceutical company focused on developing novel therapeutics to treat neurodegenerative and neurodevelopmental diseases, today announced the presentation of five scientific abstracts and an oral presentation focused on pridopidine, the company’s investigational medicine for the treatment of Huntington’s disease (HD), at the upcoming 31st annual meeting of the Huntington Study Group to be held in Cincinnati, Ohio, November 7-9, 2024.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced the appointment of two key leaders to its management team – Mr. Rob Lauzen as Chief Financial Officer (CFO) and Mr. Jason Marks, J.D. as Chief Legal Officer (CLO). The appointments are aligned with Prilenia’s progress toward the potential commercialization of pridopidine.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, announces the acceptance of its European Marketing Authorisation Application (MAA) for pridopidine (45 mg orally twice daily) for the treatment of adults with Huntington’s disease (HD) by the European Medicines Agency (EMA).

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced the presentation of the latest research from the pridopidine Huntington disease (HD) and amyotrophic lateral sclerosis (ALS) programs at the American Academy of Neurology (AAN) Annual Congress, in Denver, Colorado, April 13-18.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced the appointment of Dr. Jina Swartz, M.D. Ph.D., as its first Chief Medical Officer (CMO). In this role, Jina will lead all clinical development and medical affairs activities at Prilenia.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, announced its plan to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntington’s disease (HD) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This decision follows positive pre-submission meetings with regulatory authorities in the European Union. Submission is planned for mid-2024.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, will present clinical data supporting a future Phase 3 study in amyotrophic lateral sclerosis (ALS) during the 14th Annual California ALS Research Summit in Los Angeles. The Company has completed discussions with global regulatory agencies regarding the next stage of development of pridopidine for ALS and is planning for a single pivotal Phase 3 study to start in H2 2024.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced preliminary topline results of its Phase 3 PROOF-HD clinical study evaluating the safety and efficacy of pridopidine in individuals with Huntington’s disease (HD). These initial results, along with recently announced findings from the pridopidine arm of the HEALEY ALS Platform Trial, were presented today at the 75th American Academy of Neurology (AAN) Annual Meeting taking place in Boston, MA.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced that the last participant in PROOF-HD, a global Phase 3 study in Huntington’s disease (HD), has completed the last planned visit of the blinded treatment period, marking the completion of the main study. Almost all patients (98 percent) that were eligible elected to continue in the ongoing open-label extension of PROOF-HD. Topline results of the PROOF-HD study are expected in early Q2 2023.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative and neurodevelopmental disorders, today announced initial results from the pridopidine arm of the Phase 2 HEALEY ALS Platform Trial. Pridopidine is an oral, small molecule, highly selective and potent Sigma-1 Receptor (S1R) agonist. It is an investigational drug, and its safety and efficacy have not been determined by the FDA.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative and neurodevelopmental disorders, today announced the appointment of Anne Sullivan as Chief Business Officer. In this role, Ms. Sullivan will lead all strategic collaboration activities.

Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative and neurodevelopmental disorders, today announced that it has raised an additional $10 million, bolstering the Series B financing round and bringing total capital raised to date to $144 million.

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced the completion of participant enrollment in the pridopidine arm of the HEALEY ALS Platform Trial. The trial is led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and is designed to evaluate the safety and efficacy of multiple drug candidates in people with Amyotrophic Lateral Sclerosis (ALS).

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD).

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that it has raised $43M in an oversubscribed Series B financing round. The proceeds will be used to prepare for potential registration and commercialization of its lead drug candidate, pridopidine, for patients with Huntington’s Disease (HD) and Amyotrophic Lateral Sclerosis (ALS), as well as to accelerate timelines and expand the Company’s executive team and operations.

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced the completion of patient enrollment in the Pridopidine Outcome On Function in Huntington’s Disease (PROOF-HD) global Phase 3 clinical trial.

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, received a positive opinion on European Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis (ALS). The orphan designation is expected to be granted within 30 days, following the positive opinion issued by the EMA Committee for Orphan Medicinal Products (COMP).