Denali Therapeutics Files 8-K
Ticker: DNLI · Form: 8-K · Filed: Oct 14, 2025 · CIK: 1714899
| Field | Detail |
|---|---|
| Company | Denali Therapeutics Inc. (DNLI) |
| Form Type | 8-K |
| Filed Date | Oct 14, 2025 |
| Risk Level | low |
| Pages | 2 |
| Reading Time | 2 min |
| Key Dollar Amounts | $0.01 |
| Sentiment | neutral |
Sentiment: neutral
Topics: disclosure, regulatory
TL;DR
Denali Therapeutics filed an 8-K on Oct 13, 2025, standard disclosure.
AI Summary
Denali Therapeutics Inc. filed an 8-K on October 14, 2025, reporting events on October 13, 2025. The filing indicates a Regulation FD Disclosure and includes Financial Statements and Exhibits. No specific financial figures or material events were detailed in the provided text, but the filing itself is a standard corporate disclosure.
Why It Matters
This filing serves as a public record of corporate events and disclosures for Denali Therapeutics Inc., providing transparency to investors and the market.
Risk Assessment
Risk Level: low — This filing is a routine corporate disclosure and does not appear to contain any new material information that would immediately impact risk.
Key Players & Entities
- Denali Therapeutics Inc. (company) — Registrant
- October 13, 2025 (date) — Date of earliest event reported
- October 14, 2025 (date) — Date of Report
- Delaware (jurisdiction) — State of incorporation
- 46-3872213 (identification_number) — I.R.S. Employer Identification No.
- 161 Oyster Point Blvd. (address) — Principal executive offices
- South San Francisco (location) — City of principal executive offices
- CA (state) — State of principal executive offices
- 94080 (zip_code) — Zip code of principal executive offices
- (650) 866-8547 (phone_number) — Registrant's telephone number
FAQ
What is the primary purpose of this 8-K filing by Denali Therapeutics Inc.?
The primary purpose is to report events occurring on October 13, 2025, including a Regulation FD Disclosure and the filing of Financial Statements and Exhibits.
On what date was this 8-K form filed with the SEC?
The 8-K form was filed as of October 14, 2025.
What is Denali Therapeutics Inc.'s state of incorporation and IRS Employer Identification Number?
Denali Therapeutics Inc. is incorporated in Delaware and has an IRS Employer Identification Number of 46-3872213.
Where are Denali Therapeutics Inc.'s principal executive offices located?
The principal executive offices are located at 161 Oyster Point Blvd., South San Francisco, California, 94080.
Does this filing indicate any specific material events or financial results?
The provided text of the filing does not detail specific material events or financial results, but indicates that Financial Statements and Exhibits are included.
Filing Stats: 586 words · 2 min read · ~2 pages · Grade level 10.4 · Accepted 2025-10-14 08:10:25
Key Financial Figures
- $0.01 — ich registered Common Stock, par value $0.01 per share DNLI Nasdaq Global Select Mar
Filing Documents
- dnli-20251013.htm (8-K) — 31KB
- exhibit991pressrelease1013.htm (EX-99.1) — 13KB
- image_0a.jpg (GRAPHIC) — 13KB
- 0001714899-25-000180.txt ( ) — 180KB
- dnli-20251013.xsd (EX-101.SCH) — 2KB
- dnli-20251013_lab.xml (EX-101.LAB) — 21KB
- dnli-20251013_pre.xml (EX-101.PRE) — 12KB
- dnli-20251013_htm.xml (XML) — 3KB
01 Regulation FD Disclosure
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.
01 Financial Statements and Exhibits
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