FDA Major Amendment pushes DNLI MPS II BLA date to Apr 2026

Rhea-AI Filing Summary

Denali Therapeutics (DNLI) reported that the FDA has extended the PDUFA action date for its Biologics License Application seeking accelerated approval of tividenofusp alfa to treat MPS II (Hunter syndrome). The decision date moved from January 5, 2026 to April 5, 2026.

According to the company, the FDA granted the extension to allow review of updated clinical pharmacological information, which was classified as a Major Amendment to the BLA. The update was furnished under Regulation FD, and a related press release was included as an exhibit.

Insights

Biotech regulatory analyst

PDUFA decision shifted to April 5, 2026; procedural, neutral.

FDA extended the PDUFA date for Denali’s BLA for tividenofusp alfa in MPS II from January 5, 2026 to April 5, 2026. The agency cited review of updated clinical pharmacological information, classified as a Major Amendment.

Such extensions are an established FDA mechanism when new data are submitted. The filing does not change efficacy or safety conclusions; it indicates additional review time.

The next clear milestone is the revised action date on April 5, 2026. Actual impact will depend on the FDA’s decision at that time.

0001714899FALSE00017148992025-10-132025-10-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 13, 2025

Denali Therapeutics Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-38311

46-3872213

(State or other jurisdiction of

(Commission

(I.R.S. Employer

incorporation)

File Number)

Identification No.)

161 Oyster Point Blvd.

South San Francisco, California 94080

(Address of principal executive offices, including zip code)

(650) 866-8547

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last reports)

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 (s)			Name of each exchange on which registered
Common Stock, par value $0.01 per share			DNLI			Nasdaq Global Select Market

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 13, 2025, Denali Therapeutics Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for the Company’s Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The FDA extended the PDUFA action date from January 5, 2026 to April 5, 2026 to allow for the review of updated clinical pharmacological information which was submitted by the Company and classified as a Major Amendment to Denali's BLA. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information furnished in this Item 7.01 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “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 into 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.

Item 9.01     Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
99.1						Press release dated October 13, 2025.
104						Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

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.

						DENALI THERAPEUTICS INC.
Date:			October 14, 2025			By:			/s/ Alexander O. Schuth
									Alexander O. Schuth, M.D.
									Chief Operating and Financial Officer

FAQ

What did Denali Therapeutics (DNLI) announce in this 8-K?

The FDA extended the PDUFA action date for Denali’s BLA for tividenofusp alfa in MPS II from January 5, 2026 to April 5, 2026.

Why was DNLI’s PDUFA date extended to April 5, 2026?

The FDA needs time to review updated clinical pharmacological information, which was classified as a Major Amendment to the BLA.

What therapy is under FDA review for Denali (DNLI)?

The BLA seeks accelerated approval of tividenofusp alfa for MPS II (Hunter syndrome).

Does the 8-K state whether the FDA decision is positive or negative?

No. It only states the PDUFA date moved to April 5, 2026 due to a Major Amendment review.

What exhibit was included with DNLI’s disclosure?

A press release dated October 13, 2025 was furnished as Exhibit 99.1.