Company: DNLI
Filing Date: 2025-10-14
Form Type: 8-K
Source: 0001714899-25-000180
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Company: Denali Therapeutics Inc.
Filing Date: 2025-10-14
Form: 8-K
Item: Item 7.01
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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.