Biohaven Shares Down as FDA Extends PDUFA Data for Troriluzole

Dow Jones

May 15, 2025

By Josh Beckerman

Biohaven shares slipped after the Food and Drug Administration extended the Prescription Drug User Fee Act date for the biopharmaceutical company's troriluzole application by three months.

The stock was down 8.5%, to $17.99, after hours Wednesday and has dropped about 47% since the start of the year.

The FDA's Division of Neurology 1 also informed the New Haven, Conn., company that it plans to hold an advisory committee meeting, but no date has been scheduled. The FDA didn't raise any new concerns in its letter.

Biohaven now expects an FDA decision in the fourth quarter.

Troriluzole is a potential treatment for spinocerebellar ataxia, a group of inherited neurodegenerative disorders.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

May 14, 2025 19:10 ET (23:10 GMT)

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