BUZZ-Biohaven climbs as FDA says no advisory committee needed for genetic disorder drug

Reuters
2025.08.22 11:50
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Biohaven's shares rose 9.2% to $16.03 premarket after the FDA announced that an advisory committee meeting for its genetic disorder drug, troriluzole, is no longer necessary. The FDA had previously extended the review period for the drug, which is being tested for spinocerebellar ataxia, a rare disorder with no approved treatments. The decision is expected in Q4 of 2025, despite the stock being down 60% year-to-date.

Shares of drugmaker Biohaven (BHVN.N) rise 9.2% to $16.03 premarket

The U.S. FDA has told Biohaven that an advisory committee meeting originally planned for the application is no longer needed for decision-making, filing shows

In May, the FDA extended the review period of the marketing application for its genetic disorder drug, troriluzole

The health regulator’s decision is still expected in Q4 of 2025

Co is testing troriluzole for the treatment of adult patients with spinocerebellar ataxia, a rare disorder that affects movement and balance, and has no FDA-approved treatments

Stock down 60% YTD