Prilenia released the following community letter earlier today.

Read Full Press Release

28 April 2025

Dear Huntington’s disease community,

We are pleased to share that Prilenia has entered into a collaboration and license agreement with Ferrer for the commercialization and co-development of pridopidine in Europe and other select markets. Prilenia will retain full rights to pridopidine in other major geographies, including North America, Japan and all other countries in Asia as well as Australasia.

So, what does this mean?

This agreement marks an important step forward for Prilenia in our mission to develop and provide sustainable access to transformative medicines for people affected by devastating neurodegenerative diseases.

We are proud to partner with Ferrer as they continue to grow their presence throughout Europe and key international markets with particular focus on innovative products for rare diseases. As the highest rated pharma B corp in the world, Ferrer will ensure a strong patient and social justice approach – a cornerstone of Prilenia’s values as well. A B corp is a business that acts in ways that benefit society as a whole. What defines them is the belief that the purpose of a company is not just profits but social good.

By combining our unique strengths and shared commitment to patient communities, we believe that this partnership has the potential to accelerate the delivery of pridopidine to the thousands of people who are waiting for a new treatment option, as well as broaden its impact through additional indications in the future.

The next steps for pridopidine in HD remain unchanged.

Prilenia has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking regulatory approval of pridopidine for the treatment of HD. Our MAA is currently under review, and we are expecting an opinion from the Committee for Medicinal Products for Human Use (CHMP) in the second half of 2025. This is the first submission seeking approval for a potential treatment that can impact disease progression in HD. If approved, Prilenia and Ferrer will work expeditiously to make pridopidine available to HD patients in the countries covered in this agreement.

In the meantime, Prilenia will continue its discussions with regulatory agencies such as the U.S. Food and Drug Administration (FDA) about a potential path forward for pridopidine as a treatment option for those living with HD.

To learn more about this news and pridopidine, please read our press release here.

We remain dedicated to individuals, families, caregivers and communities affected by HD, and thank you all for your ongoing support and collaboration as we continue to advance pridopidine as a potential treatment option for people living with HD and other neurodegenerative diseases.

Sincerely,

Dr. Michael R. Hayden, CEO On behalf of the team at