NAARDEN, The Netherlands and WALTHAM, Mass. / BARCELONA, Spain, July 25, 2025 — Prilenia Therapeutics B.V. and Ferrer announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against accepting the marketing authorization application for pridopidine for Huntington's disease (HD).
We are disappointed, but we are not giving up on our commitment to bringing what we believe is an effective therapy to patients, and we will explore all options in collaboration with regulatory bodies.
Prilenia and Ferrer are focused on bringing pridopidine to people living with HD and amyotrophic lateral sclerosis (ALS) around the world as soon as possible. There are near-term plans to initiate a global study necessary for registration in HD, with the aim of providing confirmation of the previously observed results with pridopidine, as well as a global pivotal phase 3 study in ALS, with recruitment for both expected to begin as soon as possible.
