Prilenia and Ferrer Announce FDA Clearance to Start the “PREVAiLS” Pivotal Phase 3 Study with Pridopidine in ALS

Prilenia and Ferrer Announce FDA Clearance to Start the “PREVAiLS” Pivotal Phase 3 Study with Pridopidine in ALS

NAARDEN, The Netherlands & WALTHAM, Mass. & BARCELONA, Spain--(BUSINESS WIRE)--Dec 11, 2025-

FDA grants clearance to Prilenia and Ferrer’s Phase III ALS therapy trial

The US FDA has granted clearance to Prilenia Therapeutics and Ferrer to commence a Phase III trial of pridopidine in individuals with rapidly progressive amyotrophic lateral sclerosis (ALS)The post FDA grants clearance to Prilenia and Ferrer’s Phase III ALS therapy trial appeared first on Clinical Trials Arena.

FDA Clears Pivotal Phase 3 PREVAiLS Study of Pridopidine in Early, Rapidly Progressive ALS | NeurologyLive - Clinical Neurology News and Neurology Expert Insights

The phase 3 study aims to confirm findings from the HEALEY ALS platform trial in patients with early-stage rapidly progressive ALS, which suggested potential benefits of pridopidine across multiple domains.