FDA delays decision on Biohaven's Troriluzole for Spinocerebellar Ataxia due to advisory committee meeting.

From Nasdaq: 2025-05-14 23:27:00

Biohaven Ltd. received an extension on the PDUFA date for the troriluzole new drug application for treatment of spinocerebellar ataxia by FDA’s Division of Neurology 1. The FDA plans to hold an advisory committee meeting but no date is set. The decision on the NDA is expected in Q4 2025. Troriluzole received Fast-Track, Orphan Drug Designation, and Priority Review from the FDA. If approved, it would be the first FDA-approved treatment for this rare, genetic, neurodegenerative disease. For more health news, visit rttnews.com.



Read more at Nasdaq: FDA Delays Decision On Biohaven’s Troriluzole For Spinocerebellar Ataxia