Biohaven Ltd. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
$BHVN
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2025
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(203 ) 404-0410
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Item 7.01 Regulation FD Disclosure
On May 14, 2025, Biohaven Ltd. (the “Company” or “Biohaven”) issued a press release announcing that the Division of Neurology 1 (the “Division”) within the U.S. Food and Drug Administration’s (“FDA”) Office of Neuroscience informed the Company that they are extending the Prescription Drug User Fee Act (“PDUFA”) date for the troriluzole new drug application (the “NDA”) for the treatment of spinocerebellar ataxia by three months to provide time for a full review of Biohaven’s recent submissions related to information requests from the FDA. The Division also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled. The FDA’s decision regarding the NDA is now expected in the fourth quarter of 2025. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including 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”), or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Exhibit Description | |||||||
| 99.1 | ||||||||
| 104 | The cover page of this Current Report on Form 8-K formatted as Inline XBRL. | |||||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 14, 2025
| Biohaven Ltd. | |||||
| By: | /s/ Matthew Buten | ||||
| Matthew Buten | |||||
| Chief Financial Officer | |||||
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