Biohaven Ltd.
08/22/2025 | Press release | Distributed by Public on 08/22/2025 04:59
Regulation FD Disclosure (Form 8-K)
Item 7.01 Regulation FD Disclosure
Biohaven Ltd. (the "Company") provided the following update with respect to its New Drug Application ("NDA") for troriluzole for the treatment of adult patients with Spinocerebellar Ataxia ("SCA").
As previously disclosed, in May 2025, the Division of Neurology 1 (the "Division") within the Office of Neuroscience of the Food and Drug Administration (the "FDA") informed the Company that it was extending the Prescription Drug User Free Act ("PDUFA") date for the troriluzole NDA by three months to provide time for a full review of the Company's recent submissions related to information requests from the FDA. At that time, the Division also informed the Company that it was planning to hold an advisory committee meeting to discuss the application. On August 21, 2025, the Division communicated to the Company that it had determined that an advisory committee meeting is no longer needed for regulatory decision making. The FDA's expected decision regarding the NDA remains during the fourth quarter of 2025.
The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
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