Denali Therapeutics Inc. 8-K Filing

Ticker: DNLI · Form: 8-K · Filed: Dec 4, 2025 · CIK: 1714899

Denali Therapeutics Inc. 8-K Filing Summary
FieldDetail
CompanyDenali Therapeutics Inc. (DNLI)
Form Type8-K
Filed DateDec 4, 2025
Pages4
Reading Time5 min
Key Dollar Amounts$0.01
Sentimentneutral

Sentiment: neutral

FAQ

What type of filing is this?

This is a 8-K filing submitted by Denali Therapeutics Inc. (ticker: DNLI) to the SEC on Dec 4, 2025.

What are the key financial figures in this filing?

Key dollar amounts include: $0.01 (ich registered Common Stock, par value $0.01 per share DNLI Nasdaq Global Select Mar).

How long is this filing?

Denali Therapeutics Inc.'s 8-K filing is 4 pages with approximately 1,322 words. Estimated reading time is 5 minutes.

Where can I view the full 8-K filing?

The complete filing is available on SEC EDGAR. You can also read the AI-decoded analysis with risk assessment and key highlights on ReadTheFiling.

Filing Stats: 1,322 words · 5 min read · ~4 pages · Grade level 12.1 · Accepted 2025-12-04 07:01:50

Key Financial Figures

  • $0.01 — ich registered Common Stock, par value $0.01 per share DNLI Nasdaq Global Select Mar

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 4, 2025, Denali Therapeutics Inc. ("Denali" or the "Company") hosted its 2025 Investor Day , during which members of the Company's executive management team provided updates on Denali's development programs and upcoming milestones. A copy of the presentation made available in connection with the 2025 Investor Day is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in this Item 7.01, including 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"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events On December 4, 2025, Denali provided the following key updates on programs across its development pipeline at its 2025 Investor Day. Tividenofusp Alfa (ETV:IDS) — MPS II (Hunter Syndrome) The Biologics License Application ("BLA") for tividenofusp alfa remains under review with the U.S. Food and Drug Administration ("FDA"), with a Prescription Drug User Fee Act ("PDUFA") target action date of April 5, 2026. A Late Cycle Meeting with the FDA has been completed and labeling discussions are underway. Commercial readiness activities are progressing. Enrollment in Cohort A (neuronopathic) of the Phase 2/3 COMPASS study of tividenofusp alfa is expected to complete in December 2025. Tividenofusp alfa received Rare Pediatric Disease Designation ("RPDD") status for the treatment of Hunter syndrome in January 2019. Denali is in ongoing dialogue with the FDA related to the eligibility of tividenofusp alfa to receive a Rare Pediatric Disease Priority Review Voucher ("PRV") upon approval 1 . Because Denali submitted a filing of its intent to request a PRV after the initial BLA submission, based on discussions with the FDA, the Company may not be eligible to receive the PRV. Therefore, Denali is not including any potential future proceeds from the sale of a PRV in its financial planning. Denali continues to work with the FDA and the FDA will determine whether to award a PRV upon approval of tividenofusp alfa. DNL126 (ETV:SGSH) — MPS IIIA (Sanfilippo Syndrome Type A) The Phase 1/2 study of DNL126 remains on track for completion in 2026, supporting a potential accelerated approval pathway and commercial launch by the end of 2027. Denali plans to present initial Phase 1/2 data at the 2026 WORLD Symposium. Phase 3 planning is ongoing. TAK-594/DNL593 (PTV:PGRN) — Frontotemporal Dementia ( GRN Mutation) The Phase 1/2 study of TAK-594/DNL593 is ongoing with screening closed in Cohort B. Initial FTD- GRN patient data are expected in 2026 . 1 Congre

Forward-Looking Statements

Forward-Looking Statements Certain of the statements made in this report are forward looking, such as those relating to; the progress, success costs and anticipated timing of our development activities, preclinical studies and clinical trials; the timing or likelihood of regulatory filings and approvals; and our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions and limitations. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Denali may be found in Denali's Annual and Quarterly Reports filed on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (the "SEC") on February 27, 2025, and November 6, 2025, respectively, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results, or to make changes in Denali's expectations, except as required by law. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali's expectations, except as required by law.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Denali Therapeutics 2025 Investor Day Presentation 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: December 4, 2025 By: /s/ Alexander O. Schuth Alexander O. Schuth, M.D. Chief Operating and Financial Officer

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