BHVN: FDA extends PDUFA by 3 months; advisory panel no longer needed

Rhea-AI Filing Summary

Biohaven Ltd. (BHVN) reported that the FDA's Division of Neurology 1 extended the PDUFA review for the troriluzole NDA by three months in May 2025 to allow a full review of recent submissions. At that time the Division had planned an advisory committee meeting to discuss the application.

On August 21, 2025 the Division informed the company that an advisory committee meeting is no longer needed for regulatory decision making. The FDA's decision on the NDA is expected during the fourth quarter of 2025. The report and Exhibit 99.1 are being furnished and are not "filed" for Section 18 purposes.

Positive

• FDA indicated the application no longer requires an advisory committee meeting as of August 21, 2025
• The FDA maintains an expected regulatory decision window in Q4 2025, providing a clear near-term milestone

Negative

• The PDUFA date for troriluzole was extended by three months in May 2025, delaying the original review timeline
• The FDA requested additional information that required extra review time, creating interim uncertainty about timing

Insights

Regulatory Affairs Expert

TL;DR: FDA extended the PDUFA date by three months and later canceled the planned advisory committee meeting.

The three-month extension in May 2025 indicates the FDA requested additional materials requiring extra review time; this commonly lengthens sponsor uncertainty about timing but does not itself imply a negative outcome.

The Division's August 21, 2025 note that an advisory committee is "no longer needed" can streamline the path to a regulatory decision because advisory panels are often scheduled when the agency seeks external input on complex benefit-risk questions.

Clinical Development Expert

TL;DR: The procedural changes alter timing but not the substantive content of the NDA as disclosed.

The company's submissions prompted additional FDA review steps, which suggests the agency is performing detailed assessment of the provided data; however, the removal of an advisory committee reduces a potential public forum for debate that can delay decisions.

The expected FDA decision in the fourth quarter of 2025 remains the key near-term milestone to monitor.

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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): August 21, 2025

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

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.

2

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: August 22, 2025

Biohaven Ltd.
By:			/s/ Matthew Buten
			Matthew Buten
			Chief Financial Officer

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FAQ

When does the FDA now expect to decide on Biohaven (BHVN)'s troriluzole NDA?

The FDA's expected decision remains during the fourth quarter of 2025.

Why was the PDUFA date for BHVN's troriluzole extended?

The Division extended the PDUFA date by three months to allow time for a full review of the company's recent submissions addressing FDA information requests.

Will there be an advisory committee meeting for the troriluzole NDA?

No. On August 21, 2025 the FDA's Division communicated that an advisory committee meeting is no longer needed for regulatory decision making.

Is the information in this 8-K considered 'filed' under the Exchange Act?

No. The report states the information, including Exhibit 99.1, is being furnished and shall not be deemed 'filed' for Section 18 purposes.

What immediate impact does the FDA update have for investors in BHVN?

The update shifts timing: the three-month extension increases near-term uncertainty, while removal of an advisory committee could shorten procedural delay; the material near-term date is the FDA decision in Q4 2025.