FDA接受Biohaven的Vyglxia（troriluzole）SCA重新上市申请，PDUFA目标落在2027年一季度并将召开AdCom

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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):
October 22, 2026
Biohaven Ltd.
(Exact name of registrant as specified in its charter)
British Virgin Islands
001-41477
Not applicable
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
c/o Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven
,
Connecticut
06510
(Address of principal executive offices, including zip code)
(
203
)
404-0410
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading symbol
Name of each exchange on which registered
Common Shares, no par value
BHVN
New York Stock Exchange
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01    Regulation FD Disclosure.
On October 22, 2026, Biohaven Ltd. (the Company) provided an update on the spinocerebeller ataxia (SCA) program.
The FDA has informed Biohaven that the company’s new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review. The resubmission included new positive supportive analyses.
The FDA communicated that it considers the resubmission a complete response to the November 4, 2025 action letter, and has assigned a user fee goal date in the first quarter of 2027. The FDA plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee to obtain input from external stakeholders. The anticipated date of the advisory committee meeting will be forthcoming in the near term.
The information in this Item 7.01 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 liabilities of that section, 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 expressly set forth by specific reference in such a filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the FDA's review of the troriluzole NDA resubmission, the PDUFA target goal date and the potential for approval. The 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 may extend the review period, including if it determines that information submitted during the review constitutes a major amendment, may request additional information, or may issue a complete response letter. Troriluzole is an investigational drug and has not been approved for any indication in the United States.
These statements are subject to risks and uncertainties, including those described in Exhibit 99.1 and under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, that could cause actual results to differ materially. The Company undertakes no obligation to update any forward-looking statement except as required by law.
Item 9.01    Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number
Exhibit Description
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: October 22, 2026
Biohaven Ltd.
By:
/s/ Matthew Buten
Matthew Buten
Chief Financial Officer
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