FDA Accepts Vyglxia Resubmission for SCA Review

The U.S. Food and Drug Administration has accepted the new drug application resubmission for Vyglxia (troriluzole) in spinocerebeller ataxia (SCA) for review. Biohaven Ltd. disclosed this development in a Form 8-K filed with the Securities and Exchange Commission on October 22, 2026.

The resubmission included new positive supportive analyses. The FDA considers this submission a complete response to the action letter issued on November 4, 2025. As part of the acceptance, the agency assigned a user fee goal date for the first quarter of 2027. This PDUFA target action date is a goal and does not assure that the FDA will act by that date or approve the NDA.

The FDA intends to hold a session with the Peripheral and Central Nervous System Advisory Committee to gather perspectives from outside parties. The specific date for this advisory committee meeting will be announced in the near term. Biohaven Ltd., incorporated in the British Virgin Islands, reports its principal executive offices in New Haven, Connecticut. Its common shares trade on the New York Stock Exchange under the symbol BHVN.

Matthew Buten, Chief Financial Officer of Biohaven Ltd., signed the current report on behalf of the company. The filing states that the information provided is furnished and not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934. The company notes that the review process is subject to risks and uncertainties. The FDA may extend the review period if it determines that information submitted constitutes a major amendment, requests additional information, or issues a complete response letter. Troriluzole remains an investigational drug and has not been approved for any indication in the United States.