FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia
- Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. - Troriluzole has been granted Fast-Track, Orphan Drug Designation (ODD) and Priority Review from the FDA.- Troriluzole would be the first and only FDA-approved treatment for SCA, if approved.NEW HAVEN, Conn., May 14, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed th ...