# Biohaven Shares Rise About 25% After FDA Accepts Resubmission

By Riza Dagoc

Canonical URL: https://www.tokenpost.com/news/regulation/38596
Published: 2026-10-23T02:34:29.000Z
Updated: 2026-10-23T02:34:29.000Z
Section: Regulation

> The agency set a first-quarter 2027 user-fee goal date and plans to convene an advisory committee, with no meeting date announced.

Biohaven Ltd. shares closed about 25% higher Thursday, Oct. 22, after the company disclosed that the U.S. Food and Drug Administration had accepted its resubmitted application for Vyglxia (troriluzole), an investigational treatment for spinocerebellar ataxia.

The FDA set a user-fee goal date in the first quarter of 2027 and plans to convene its Peripheral and Central Nervous System Advisory Committee. No meeting date has been announced. The resubmission includes new supportive analyses.

Evidence had not established troriluzole’s effectiveness for spinocerebellar ataxia, and Study 206-RWE did not qualify as an adequate, well-controlled investigation. Year 3 ataxia-rating data were unavailable for 52% of treated subjects and 79% of external-control subjects.

Troriluzole remains investigational and is not approved for any use in the United States. The first-quarter 2027 goal date is a target; it does not guarantee when the FDA will act or whether the application will be approved.