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.
Denali Therapeutics Inc. filings document regulatory, financial and governance disclosures for a biotechnology company developing blood-brain-barrier-crossing therapeutics. Recent 8-K reports record operating results, FDA approval and launch-related disclosures for AVLAYAH™, clinical pipeline updates, and material events tied to collaboration agreements and royalty funding arrangements.
Denali’s proxy materials cover board matters, executive compensation, equity awards and shareholder voting items. Its event filings also describe capital-structure and financing obligations, Regulation FD disclosures, exhibit-based press releases, and formal updates on TransportVehicle-enabled programs across lysosomal storage and neurodegenerative disease indications.
T. Rowe Price Investment Management, Inc. files a Schedule 13G reporting beneficial ownership of 8,519,192 shares of Denali Therapeutics common stock.
The filing states this represents 5.4% of the class as of 03/31/2026, and shows sole voting power of 8,503,878 and sole dispositive power of 8,519,192. The filing is signed on 05/15/2026.
Denali Therapeutics reported a Q1 2026 net loss of $128.4 million, slightly improved from $133.0 million a year earlier, as total operating expenses fell 6% to $137.4 million. Research and development was $103.8 million, reflecting lower small-molecule and manufacturing spend, while general and administrative rose to $33.5 million as the company prepared for commercialization.
Cash, cash equivalents and marketable securities totaled $1.05 billion as of March 31, 2026, supported by $200 million of non‑dilutive funding from a synthetic royalty agreement with Royalty Pharma tied to AVLAYAH sales. AVLAYAH, approved in March 2026 for neurologic manifestations of Hunter syndrome, began U.S. commercial distribution in April. The quarter also added a $36.0 million AVLAYAH‑related milestone as an intangible asset and recorded a $199.6 million liability for the revenue participation right.
Denali Therapeutics reported first quarter 2026 results alongside a major pipeline milestone. The FDA granted accelerated approval for AVLAYAH, a TransportVehicle-enabled therapy for Hunter syndrome, and Denali has begun its U.S. commercial launch with initial patients treated and distribution, support hub, and payer engagement in place.
Net loss was $128.4 million for the quarter ended March 31, 2026, slightly improved from $133.0 million a year earlier, as research and development expenses declined to $103.8 million from $116.2 million. General and administrative expenses rose to $33.5 million, reflecting hiring to support AVLAYAH’s launch.
Denali ended the quarter with approximately $1.05 billion in cash, cash equivalents and marketable securities, helped by $200 million in gross proceeds from a synthetic royalty funding agreement with Royalty Pharma. The company also received a Rare Pediatric Disease Priority Review Voucher and continues to advance a broad neurological and lysosomal disorder pipeline with multiple mid-stage trials and key data readouts expected between 2026 and 2027.
FMR LLC filed an amendment to a Schedule 13G/A reporting beneficial ownership of 6,672,999.32 shares of Denali Therapeutics common stock, representing 4.2% of the class. The filing (Cover CUSIP 24823R105) shows sole dispositive power and is signed May 5, 2026.
Denali Therapeutics Inc. executive Peter Scott Chin filed an amended Form 3 to restate his reported common stock holdings. The filing updates Table I to show direct ownership of 204,402 shares of Denali Therapeutics common stock. It does not report any new stock purchases or sales.
Denali Therapeutics Inc. is asking stockholders to vote at its virtual 2026 Annual Meeting on June 3, 2026 at 10:00 a.m. Pacific Time. Holders of 158,675,498 shares of common stock outstanding as of April 9, 2026 may vote.
Stockholders will elect three Class III directors (Jennifer Cook, David Schenkein, M.D., and President and CEO Ryan Watts, Ph.D.), ratify Ernst & Young LLP as independent auditor for 2026, and approve, on an advisory basis, executive compensation. The board is composed of nine directors, eight of whom are independent, and recommends voting FOR all three proposals.
The proxy describes virtual participation and multiple voting methods, outlines board and committee structures, summarizes director independence, risk oversight, cybersecurity and environmental initiatives, and discloses 2024–2025 audit fees and stockholder procedures for future proposals and director nominations.
Denali Therapeutics Inc. Chief Medical Officer Peter Scott Chin filed an initial ownership report showing direct holdings of 170,612 shares of common stock, including 2,326 shares acquired under the Denali ESPP and 145,845 unvested RSUs. He also holds multiple fully vested or time-vesting stock options to buy common shares at exercise prices ranging from $20.17 to $80.03, with expirations extending through 2036. These positions reflect equity-based compensation typical for a senior executive and do not represent new market purchases or sales.
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.