Company: DNLI
Filing Date: 2025-04-02
Form Type: 8-K
Source: 0001714899-25-000077
Chunk: 0

Company: Denali Therapeutics Inc.
Filing Date: 2025-04-02
Form: 8-K
Item: Item 7.01
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Item 7.01 Regulation FD Disclosure.

On April 2, 2025, Denali Therapeutics Inc. issued a press release announcing it has initiated a rolling submission of a biologics license application for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II).

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.