Denali Therapeutics INC
Market Movers (8-K)
NASDAQ
Denali Therapeutics Inc. has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher for $195 million to support its clinical pipeline.
NASDAQ
Denali Therapeutics announced first quarter 2026 financial results, highlighting the FDA approval and U.S. launch of AVLAYAH for Hunter syndrome, alongside progress in its neurodegenerative disease pipeline.
NASDAQ
Denali Therapeutics announced it has regained full control of its investigational therapy DNL593 for FTD-GRN after Takeda terminated their collaboration agreement.
Capital raise
NASDAQ
Denali Therapeutics Inc. received $200 million in gross proceeds from a synthetic royalty funding agreement with Royalty Pharma following FDA accelerated approval of tividenofusp alfa.
Better than expected
Capital raise
NASDAQ
Denali Therapeutics announced FDA accelerated approval for AVLAYAH (tividenofusp alfa-eknm), a first-in-class brain-penetrant therapy for neurologic manifestations of Hunter syndrome.
Better than expected
NASDAQ
Denali Therapeutics reported its fourth quarter and full year 2025 financial results, highlighting significant progress in its clinical pipeline and commercial readiness for tividenofusp alfa.
Worse than expected
Capital raise
Quarterly Earnings (10-Q)
NASDAQ
Denali Therapeutics reports Q3 2025 financial results with increased net losses, DNL310 BLA review extension, and discontinuation of the DNL343 ALS trial.
Worse than expected
Capital raise
Delay expected
NASDAQ
Denali Therapeutics reported increased Q2 losses but achieved significant clinical and regulatory milestones for its lead neurodegenerative and lysosomal storage disease programs.
Capital raise
Better than expected
NASDAQ
Denali Therapeutics reports a net loss for Q1 2025, provides updates on clinical programs, and highlights financial position.
Worse than expected
Capital raise
NASDAQ
Denali Therapeutics reported its third quarter 2024 financial results, highlighting progress in its clinical programs and strategic initiatives.
Worse than expected
Delay expected
NASDAQ
Denali Therapeutics reports a net loss for Q2 2024, alongside a strategic divestiture of preclinical small molecule programs and a focus on TV-enabled platforms.
Worse than expected
Delay expected
NASDAQ
Denali Therapeutics reports a net loss of $101.8 million for Q1 2024, alongside a strategic divestiture of preclinical small molecule programs and a significant capital raise.
Worse than expected
Delay expected
Capital raise
Annual Reports (10-K)
NASDAQ
Denali Therapeutics reports increased net losses in 2025, alongside significant clinical advancements for its TransportVehicle platform and key program updates, including a PDUFA extension for tividenofusp alfa.
Worse than expected
Capital raise
Delay expected
NASDAQ
Denali Therapeutics plans to submit a BLA for its Hunter Syndrome drug in early 2025 and is preparing for a potential commercial launch.
Delay expected
Worse than expected
Capital raise
NASDAQ
Denali Therapeutics' 10-K filing highlights its focus on developing therapies for neurodegenerative and lysosomal storage diseases using its proprietary blood-brain barrier crossing technology.
Worse than expected
Delay expected
Capital raise
Insider Trading (Form 4)
NASDAQ
Director Jay Flatley was granted 6,408 restricted stock units and 19,226 stock options as part of annual compensation for his role on the board.
NASDAQ
Director Peter S. Klein was awarded 6,408 restricted stock units and 19,226 stock options as part of his compensation package at Denali Therapeutics.
NASDAQ
Director Steve E. Krognes was granted 6,408 restricted stock units and 19,226 stock options as part of annual board compensation.
NASDAQ
Director David P. Schenkein was granted 6,408 restricted stock units and 19,226 stock options as part of annual compensation for his role on the board.
NASDAQ
Director Nancy Thornberry was granted 6,408 restricted stock units and 19,226 stock options as part of her annual compensation package.
NASDAQ
Director Timothy Van Hauwermeiren received an equity grant of 6,408 RSUs and 19,226 stock options from Denali Therapeutics.
Proxy Statements (Def-14A)
NASDAQ
Denali Therapeutics Inc. has issued its 2026 proxy statement detailing the upcoming annual meeting, director elections, and executive compensation advisory vote.
Capital raise
NASDAQ
Denali Therapeutics Inc. has filed definitive additional materials related to its proxy statement with the Securities and Exchange Commission.
NASDAQ
Denali Therapeutics will hold its 2025 Annual Meeting of Stockholders virtually on June 3, 2025, to vote on director elections, auditor ratification, and executive compensation.
Capital raise
NASDAQ
Denali Therapeutics Inc. has filed a definitive proxy statement with the SEC.
NASDAQ
Denali Therapeutics will hold its 2024 Annual Meeting of Stockholders virtually on May 31, 2024, to vote on director elections, auditor ratification, and executive compensation.
Schedule 13G - Passive Investments
NASDAQ
Baillie Gifford & Co. has reported a beneficial ownership of 7.5% in Denali Therapeutics Inc. common stock as of June 30, 2026.
NASDAQ
T. Rowe Price Investment Management, Inc. has reported beneficial ownership of 16,178,963 shares, representing 10.2% of the outstanding common stock of Denali Therapeutics Inc.
NASDAQ
FMR LLC, through its subsidiaries, has reported a 4.2% beneficial ownership of Denali Therapeutics Inc. common stock as of March 31, 2026.
NASDAQ
The Vanguard Group has filed an amendment to its Schedule 13G, reporting zero beneficial ownership in Denali Therapeutics Inc. following an internal realignment.
NASDAQ
FMR LLC and Abigail P. Johnson have filed an amended Schedule 13G, disclosing a 5.8% beneficial ownership stake in Denali Therapeutics Inc. common stock.
NASDAQ
Wellington Management Group LLP and its affiliates have reduced their beneficial ownership in Denali Therapeutics Inc. to 3.9% of common stock.