Biohaven Ltd (NASDAQ:BHVN) shares are down after the company announced multiple updates on key programs.
On its SCA program, the FDA informed Biohaven that it would not review the recently submitted marketing application for troriluzole given that the study’s primary endpoint was not met and, thus, would not permit a substantive review.
The communication from the FDA indicated that the company may request a Type A meeting within 30 days.
Biohaven is committed to working closely with the FDA to bring troriluzole to people with Spinocerebellar ataxia type 3 (SCA3).
Any updates regarding the Type A meeting will be provided after the upcoming regulatory interaction.
Troriluzole’s active metabolite has a known safety profile and is well-tolerated, and troriluzole was submitted under a 505(b)(2) application with data suggesting an 80% reduction or 7-month benefit in disease progression over the 1-year study period.
William Blair analysts Tim Lugo, Lachlan Hanbury-Brown, and John Boyle say the update is disappointing, but there may still be a path to approval following the type A meeting with the FDA. It is unlikely the agency will reverse its decision without additional clinical data. It maintains the Outperform rating.
Price Action: BHVN shares are down 25.9% at $17.64 on the last check Thursday.
