Biohaven Pharmaceuticals (BHVN), on Tuesday announced that the FDA has accepted its New Drug Application for Troriluzole for the treatment of adult patients with spinocerebellar ataxia, granting the application Priority Review.
Spinocerebellar ataxia (SCA) is a group of dominantly inherited neurodegenerative disorders characterized by progressive loss of voluntary motor control and atrophy of the cerebellum and brainstem.
This designation highlights the urgent need for treatments for SCA, a rare, life-threatening neurodegenerative disease with no current FDA-approved therapies.
Troriluzole, a glutamate modulator, has demonstrated the ability to significantly slow disease progression in patients with SCA, showing a 50-70 percent reduction in disease progression at the 3-year endpoint in a real-world evidence study.
The NDA submission is based on positive results from the Phase 2 trials, where troriluzole showed sustained, clinically meaningful benefits, including slowing functional decline and reducing falls in SCA patients. If approved, troriluzole will become the first and only FDA-approved treatment for this devastating condition.
With Priority Review in place, Biohaven is expected to receive an FDA decision by 3Q 2025.
Biohaven also received an Orphan Drug Designation for troriluzole for SCA, emphasizing the need for accelerated access to therapies for this rare disease.
BHVN closed Monday's (Feb.10 2025) trading at $38.25 down 0.47%. In premarket trading Tuesday, the stock is up by 8.60% at $41.54
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