Welcome to our dedicated page for Denali Therapeut SEC filings (Ticker: DNLI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Denali Therapeutics Inc. (DNLI) SEC filings page on Stock Titan provides access to the company’s publicly filed documents, including current reports on Form 8‑K and other disclosures incorporated by reference. Denali is a biotechnology and biopharmaceutical company based in South San Francisco, California, focused on product candidates engineered to cross the blood-brain barrier for neurodegenerative and lysosomal storage diseases.
Recent Form 8‑K filings referenced by the company include reports of quarterly financial results, such as second and third quarter 2025 results, and Regulation FD disclosures related to key regulatory milestones. For example, Denali filed 8‑K reports describing FDA acceptance and Priority Review of the Biologics License Application for tividenofusp alfa (DNL310) for Hunter syndrome (MPS II), and a subsequent extension of the Prescription Drug User Fee Act (PDUFA) target action date after submission of updated clinical pharmacology information classified as a Major Amendment.
Through this page, users can track how Denali reports material events such as clinical and regulatory updates, financial results and capital markets transactions, including public offerings of common stock and pre-funded warrants registered on Form S‑3. The filings complement the company’s press releases by providing formal regulatory context and references to exhibits such as earnings releases and detailed financial statements.
Stock Titan enhances access to these filings with tools designed to help readers quickly locate relevant 8‑K disclosures, review historical reporting patterns and connect SEC documents with related news about Denali’s TransportVehicle™ platform, pipeline programs and collaborations.
Denali Therapeutics reports that Takeda will terminate their collaboration agreement to co-develop and co-commercialize the investigational therapy DNL593 for GRN-related frontotemporal dementia. The decision is based on strategic considerations and not on efficacy or safety data.
The termination becomes effective 60 days after the April 3, 2026 notice, at which point all rights in the DNL593 program and its intellectual property will revert to Denali, and Denali will have no further financial obligations to Takeda. Denali plans to continue independent clinical development of DNL593 and expects results from an ongoing Phase 1/2 study by the end of 2026.
Denali Therapeutics Inc. reported that on March 27, 2026 it received $200.0 million in gross proceeds at the closing of its previously disclosed synthetic royalty funding agreement with Royalty Pharma. The closing occurred after the U.S. Food and Drug Administration granted accelerated approval to tividenofusp alfa on March 24, 2026.
Denali Therapeutics Inc: Amendment No. 6 to a Schedule 13G/A states that The Vanguard Group beneficially owns 0 shares of Denali common stock, representing 0% of the class. The filing explains an internal realignment effective January 12, 2026, under SEC Release No. 34-39538 that caused certain Vanguard subsidiaries and business divisions to report separately.
Denali Therapeutics reported that the U.S. FDA granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), an enzyme replacement therapy for neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
The drug is specifically engineered to cross the blood-brain barrier using Denali’s TransportVehicle platform and showed a 91% reduction in cerebrospinal fluid heparan sulfate by week 24 in a Phase 1/2 trial, with most treated patients reaching levels seen in individuals without Hunter syndrome. Continued approval may depend on confirmatory benefit in the ongoing Phase 2/3 COMPASS study, and the FDA granted Denali a Rare Pediatric Disease Priority Review Voucher in connection with the approval.
Denali Therapeutics outlines its strategy to use its proprietary Transport Vehicle (TV) platform to move large-molecule drugs across the blood–brain barrier and treat neurodegenerative and lysosomal storage diseases. The report emphasizes three pillars: Discover, Develop and Deliver, with specific three‑year “D3X3” goals.
Lead program tividenofusp alfa for Hunter syndrome has a biologics license application under priority review, with a PDUFA target action date of April 5, 2026, and is intended as the company’s first commercial launch. DNL126 for Sanfilippo syndrome type A, multiple Alzheimer’s programs (DNL628 and DNL921), Pompe candidate DNL952 and LRRK2 inhibitor BIIB122/DNL151 for Parkinson’s disease are progressing through clinical development under collaborations with Biogen, Takeda and Sanofi. The company reports 158,591,491 common shares outstanding as of February 20, 2026 and describes a rare‑disease–focused commercial build‑out intended to fund broader TV-platform expansion.
Denali Therapeutics reported a wider net loss of $128.5 million for the fourth quarter and $512.5 million for full-year 2025, compared with losses of $114.8 million and $422.8 million in 2024. Net loss per share was $0.73 for the quarter and $2.97 for the year.
Research and development expenses were $97.9 million in the quarter and $418.8 million for the year, while general and administrative costs rose to $39.5 million and $136.6 million, mainly to prepare for the potential launch of tividenofusp alfa for Hunter syndrome. Denali ended 2025 with $966.2 million in cash, cash equivalents and marketable securities, helped by a $275.0 million synthetic royalty funding deal with Royalty Pharma and approximately $200.0 million in net proceeds from a public offering.
The company highlighted launch readiness for tividenofusp alfa ahead of the April 5, 2026 PDUFA decision and encouraging biomarker data for DNL126 in Sanfilippo syndrome type A. Multiple additional programs advanced across Alzheimer’s disease, Pompe disease, frontotemporal dementia, Parkinson’s disease and ulcerative colitis, with several key clinical readouts expected in 2026.
Denali Therapeutics insider Carole Ho has filed a Rule 144 notice to sell 39,490 shares of common stock. The shares are to be sold on NASDAQ through Morgan Stanley Smith Barney LLC Executive Financial Services, with an indicated aggregate market value of 801,394.26.
The shares were acquired on 02/05/2026 by exercising stock options under a registered plan for cash. In the prior three months, Carole Ho sold 150,000 common shares on 02/03/2026 for gross proceeds of 3,324,060.00 and 150,000 common shares on 02/04/2026 for gross proceeds of 3,176,970.00.
A person named Carole Ho has filed a Rule 144 notice indicating an intention to sell 150,000 shares of common stock through Morgan Stanley Smith Barney LLC on NASDAQ. The filing lists an aggregate market value of 3,176,970.00 for these shares and shows 146,661,833 shares outstanding.
The notice also reports that on 02/04/2026 options were exercised under a registered plan to acquire 36,042 and 113,958 common shares for cash. In the past three months, the same seller disposed of 150,000 common shares for 3,324,060.00.
A shareholder in DNLI has filed a notice of intent to sell 150,000 shares of common stock on the NASDAQ, with an aggregate market value of $3,324,060. The planned sales are to be executed through Morgan Stanley Smith Barney LLC Executive Financial Services, with an approximate sale date of February 3, 2026.
The shares were acquired on February 2, 2026 by exercising stock options under a registered plan, in three transactions for 22,042, 44,021, and 83,937 shares, all paid in cash. The filing notes that there were 146,661,833 shares of this class of stock outstanding.
Denali Therapeutics Inc. President and CEO Ryan J. Watts reported a sale of common stock in a Form 4 filing. On January 6, 2026, he sold 35,198 shares of Denali common stock at $16.50 per share, and the filing explains that these shares were sold to satisfy tax obligations related to the settlement of previously vested restricted stock units (RSUs). Following this transaction, he directly beneficially owned 296,833 shares, which include 184,915 unvested RSUs. The filing also reports an additional 2,152,604 shares held indirectly through the Watts Family 2015 Trust, for which he serves as trustee.