Denali Therapeutics INC 8-K filings

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.

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.

Denali Therapeutics announced it has regained full control of its investigational therapy DNL593 for FTD-GRN after Takeda terminated their collaboration agreement.

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.

Denali Therapeutics announced FDA accelerated approval for AVLAYAH (tividenofusp alfa-eknm), a first-in-class brain-penetrant therapy for neurologic manifestations of Hunter syndrome.

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.

Denali Therapeutics announces key anticipated milestones for 2026, including the commercial launch preparation for tividenofusp alfa for Hunter syndrome and multiple clinical data readouts.

Denali Therapeutics Inc. announced the pricing of a public offering of common stock and pre-funded warrants, aiming to raise approximately $200 million.

Denali Therapeutics provided key updates on its development programs and upcoming milestones at its 2025 Investor Day, including regulatory progress for tividenofusp alfa and DNL126, and new clinical initiatives for Alzheimer's and Pompe disease.

Denali Therapeutics entered a $275 million synthetic royalty funding agreement with Royalty Pharma for its investigational Hunter syndrome therapy, tividenofusp alfa.

Denali Therapeutics reported a wider net loss in Q3 2025, with increased R&D and G&A expenses, while the FDA extended its review of tividenofusp alfa for Hunter syndrome and new clinical applications were submitted for Alzheimer's and Pompe diseases.

The FDA has extended the PDUFA action date for Denali Therapeutics' tividenofusp alfa for Hunter syndrome by three months to April 5, 2026, following a Major Amendment submission.

Denali Therapeutics reports Q2 2025 financial results, highlighting FDA priority review for tividenofusp alfa and accelerated approval path for DNL126.

Denali Therapeutics announced the U.S. Food and Drug Administration has accepted and granted Priority Review for its Biologics License Application for tividenofusp alfa, a potential new treatment for Hunter syndrome, setting a PDUFA target action date of January 5, 2026.

Denali Therapeutics Inc. announced the execution of a registration rights agreement with Baker Brothers Life Sciences, L.P. and 667, L.P., alongside the results of its annual stockholders' meeting, including director elections and key corporate governance approvals.

Denali Therapeutics announces the completion of its Biologics License Application (BLA) submission for tividenofusp alfa for Hunter syndrome and reports its first quarter 2025 financial results.

Denali Therapeutics has begun a rolling submission of a biologics license application (BLA) to the FDA for tividenofusp alfa, aimed at treating Hunter syndrome (MPS II), with potential U.S. commercial launch anticipated in late 2025 or early 2026.

Denali Therapeutics' DNL343 did not demonstrate a treatment effect on neurofilament light (NfL) in a Phase 2/3 trial for ALS, leading to the discontinuation of the active treatment extension.

Denali Therapeutics reported its Q4 and full year 2024 financial results, highlighting progress in its ETV programs and a potential accelerated approval for its lead program in MPS II.

Denali Therapeutics outlines key milestones for 2025, including a BLA submission for tividenofusp alfa and advancing its TransportVehicleTM (TV) enabled programs.

Denali Therapeutics announced that its eIF2B agonist DNL343 did not meet primary or key secondary endpoints in a Phase 2/3 trial for ALS, though it was found to be safe and well-tolerated.

Denali Therapeutics has amended and restated its bylaws to comply with SEC rules on universal proxy cards and to enhance corporate governance.

Denali Therapeutics reported its third quarter 2024 financial results, highlighted by progress in its Transport Vehicle (TV) enabled portfolio and plans for accelerated approval of tividenofusp alfa.

Denali Therapeutics and Sanofi have discontinued the K2 Phase 2 study of oditrasertib for multiple sclerosis after it failed to meet primary and key secondary endpoints.

Denali Therapeutics announced its second quarter 2024 financial results, highlighted by the regaining of rights to its ATV:Abeta Alzheimer's program and progress in its clinical pipeline.

Denali Therapeutics held its annual meeting on May 31, 2024, where shareholders elected three Class I directors, ratified the appointment of Ernst & Young LLP as the independent auditor, and approved executive compensation on an advisory basis.

Denali Therapeutics announced its first quarter 2024 financial results, highlighting progress in clinical programs and a recent $500 million private investment.

Denali Therapeutics announced its fourth quarter and full year 2023 financial results, highlighted by a $500 million private investment and progress in its clinical programs, while also reporting a net loss.

Denali Therapeutics has raised approximately $500 million through a private placement to support its research and development activities, particularly its blood-brain barrier crossing technology.

Denali Therapeutics' strategic partner, Sanofi, reported that the Phase 2 HIMALAYA study of SAR443820/DNL788 for amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint, while a separate study for multiple sclerosis will continue.