DNLI
NASDAQDenali Therapeutics Inc.
Price$19.46-0.68 (-3.35%)
01:30 PM07:45 PM
News · 26 weeks46+100%
2025-10-262026-04-19
Mix2090d
- SEC Filings8(40%)
- Other6(30%)
- Analyst2(10%)
- Insider2(10%)
- Offering1(5%)
- Earnings1(5%)
Latest news
25 items- INSIDERAmendment: SEC Form 3 filed by new insider Chin Peter Scott3/A - Denali Therapeutics Inc. (0001714899) (Issuer)
- SECSEC Form DEFA14A filed by Denali Therapeutics Inc.DEFA14A - Denali Therapeutics Inc. (0001714899) (Filer)
- SECSEC Form DEF 14A filed by Denali Therapeutics Inc.DEF 14A - Denali Therapeutics Inc. (0001714899) (Filer)
- INSIDERSEC Form 3 filed by new insider Chin Peter Scott3 - Denali Therapeutics Inc. (0001714899) (Issuer)
- PRWhen Science Becomes an Asset: How Advancing Drug Pipelines Are Driving Real-Time Valuation in BiotechAUSTIN, Texas, April 20, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Biotechnology is undergoing a quiet but profound transformation, one that is reshaping how investors understand value in a sector historically defined by long timelines and uncertain outcomes. As drug candidates advance closer to commercialization, scientific progress is no longer viewed solely as research expenditure but increasingly as a measurable financial asset. This shift is being reinforced by fair-value accounting under U.S. GAAP, which allows life sciences companies to reflect clinical progress, probability of success and commercialization timing as measurable balance sheet value. Leading companies, s
- SECDenali Therapeutics Inc. filed SEC Form 8-K: Termination of a Material Definitive Agreement, Financial Statements and Exhibits8-K - Denali Therapeutics Inc. (0001714899) (Filer)
- PRDenali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)Denali plans to continue clinical development of DNL593, which is designed to deliver progranulin to the brain using TransportVehicle™ technologyResults from ongoing Phase 1/2 study in patients with FTD-GRN expected by the end of 2026 SOUTH SAN FRANCISCO, Calif., April 03, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that it has received notification from Takeda of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593 (PTV:PGRN). The decision was driven by strategic considerations and is not related to efficacy or safety data. DNL593 is an investigational progranulin replacement therapy
- SECDenali Therapeutics Inc. filed SEC Form 8-K: Creation of a Direct Financial Obligation, Entry into a Material Definitive Agreement, Regulation FD Disclosure8-K - Denali Therapeutics Inc. (0001714899) (Filer)
- SECAmendment: SEC Form SCHEDULE 13G/A filed by Denali Therapeutics Inc.SCHEDULE 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)
- ANALYSTH.C. Wainwright reiterated coverage on Denali Therapeutics with a new price targetH.C. Wainwright reiterated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $42.00 from $32.00 previously
- SECDenali Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - Denali Therapeutics Inc. (0001714899) (Filer)
- PRDenali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrierDenali's first medicine enabled by its TransportVehicle™ platform designed to deliver biotherapeutics to whole body, including brainRare Pediatric Disease Priority Review Voucher (PRV) awarded in connection with FDA approvalDenali to host conference call and webcast today at 12:30 p.m. Eastern time SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the U.S. Food and Drug Adm
- SECSEC Form 10-K filed by Denali Therapeutics Inc.10-K - Denali Therapeutics Inc. (0001714899) (Filer)
- SECSEC Form S-8 filed by Denali Therapeutics Inc.S-8 - Denali Therapeutics Inc. (0001714899) (Filer)
- SECDenali Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits8-K - Denali Therapeutics Inc. (0001714899) (Filer)
- PRDenali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business HighlightsTividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndromeDNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type AStart-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe diseaseTransportVehicle™ platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative diseases SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc.
- ANALYSTWolfe Research initiated coverage on Denali TherapeuticsWolfe Research initiated coverage of Denali Therapeutics with a rating of Peer Perform
- PRDrug-Delivery Breakthroughs, Cross-Indication Research Accelerate New Momentum in CNS and Oncology DevelopmentAUSTIN, Texas, Feb. 19, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Biotechnology mergers and acquisitions (M&As) are increasingly shaped by a clear strategic evolution. Pharmaceutical companies are prioritizing clinical-stage and late-stage programs supported by human data rather than early discovery platforms with uncertain timelines. Following a period where capital heavily favored preclinical innovation, investors and acquirers are now focusing on assets that demonstrate safety signals, efficacy data and clearer pathways toward commercialization. Within this shifting landscape, companies holding diversified clinical-stage portfolios across oncology and central nervous syste
- PRDenali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™Analysis from continued follow-up of Phase 1/2 clinical trial data in Hunter syndrome (MPS II) reinforces potential for tividenofusp alfa (DNL310) to address full disease spectrumLaunch readiness established in anticipation of April 5, 2026, Prescription Drug User Fee Act (PDUFA) date for tividenofusp alfaPreliminary Phase 1/2 study data show treatment with DNL126 (ETV:SGSH) substantially reduced disease biomarkers in cerebrospinal fluid (CSF) and peripheral tissues, including an 80% mean reduction in CSF heparan sulfate, in Sanfilippo syndrome type A (MPS IIIA); safety profile generally consistent with established enzyme replacement therapiesDesign of ongoing DNL952 (ETV:GAA) Phase 1 clinic
- PRDenali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™SOUTH SAN FRANCISCO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that management will host a live webcast to review presentations on its Enzyme TransportVehicle™ (ETV) programs at the upcoming 22nd Annual WORLDSymposium™ being held February 2-6, 2026, in San Diego, California. These presentations will demonstrate the broad potential of the ETV to enable the delivery of enzyme replacement therapies to the whole body, including the brain. Titles and times for the presentations were previously announced in a corporate news release here. The live webcast will begin at 12:30 p.m. Pacific Time on Thursday, February 5, 2026, and can be accessed
- INSIDERPresident and CEO Watts Ryan J. sold $580,767 worth of shares (35,198 units at $16.50), decreasing direct ownership by 11% to 296,833 units (SEC Form 4)4 - Denali Therapeutics Inc. (0001714899) (Issuer)
- INSIDERCOFO and Secretary Schuth Alexander O. sold $284,097 worth of shares (17,218 units at $16.50), decreasing direct ownership by 6% to 282,828 units (SEC Form 4)4 - Denali Therapeutics Inc. (0001714899) (Issuer)
- ANALYSTUBS resumed coverage on Denali Therapeutics with a new price targetUBS resumed coverage of Denali Therapeutics with a rating of Buy and set a new price target of $25.00
- SECSEC Form 144 filed by Denali Therapeutics Inc.144 - Denali Therapeutics Inc. (0001714899) (Subject)
- SECDenali Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - Denali Therapeutics Inc. (0001714899) (Filer)