Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has ...
Biohaven: NDA Review Of Troriluzole Isn't Only 2025 Catalyst On Deck
Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...
Monthly Prescribing Reference6d
Troriluzole Priority Review Granted for Spinocerebellar Ataxia
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with ...
Biohaven’s troriluzole NDA in spinocerebellar ataxia accepted by the FDA
Biohaven (BHVN) announced that the FDA has accepted for review the company’s New Drug Application, or NDA, for troriluzole for the treatment of ...
Morningstar9d
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Troriluzole demonstrated a 50-70% slowing of SCA disease progression on the primary and secondary outcome measures at the 3-year endpoint in a real-world evidence (RWE) study. Troriluzole has a ...
Investing9d
Biohaven's troriluzole gains FDA priority review for SCA
Troriluzole could become the first FDA-approved treatment for SCA, aiming to address a critical unmet medical need. The FDA's decision on the NDA is anticipated by the third quarter of 2025.