Biohaven troriluzole pivotal SCA study meets primary endpoint; NDA planned Q4 2024

Biohaven Ltd.

Troriluzole 200 mg once-daily met primary endpoint on f-SARA change from baseline at 3 years in all SCA genotypes.
SCA patients showed 50-70% slower disease progression vs untreated controls, translating to 1.5-2.2 years delay.
Odds ratio for 2+ point f-SARA worsening at 3 years was 4.1 (95% CI: 2.1, 8.1; p<0.0001) favoring troriluzole.
Biohaven to submit NDA to FDA in Q4 2024; eligible for priority review given orphan/fast-track designations.
Company plans US commercialization in 2025 if approved; no FDA-approved treatments currently exist for SCA.

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