FDA extends Biohaven's troriluzole PDUFA date to 4Q 2025, plans advisory committee meeting

Biohaven Ltd.

FDA extends PDUFA date by 3 months to 4Q 2025 for troriluzole NDA for spinocerebellar ataxia (SCA).
FDA plans to hold an advisory committee meeting to discuss the application; no date set.
FDA did not raise new concerns; mid-cycle review found no major safety issues and no REMS needed.
Troriluzole has Fast-Track, Orphan Drug, and Priority Review status; would be first approved SCA treatment.
Clinical data showed 50-70% slowing of disease progression and reduced fall risk in SCA.

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