$DNLI News
Last published 1w ago
- 1w agoDNLIDenali Therapeutics Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 1w agoDNLIDenali Therapeutics Reports Third Quarter 2026 Financial Results and Business HighlightsGlobeNewswireAVLAYAH® (tividenofusp alfa-eknm) net product revenue accelerated to $17.8 million in its second full commercial quarterContinued growth expectations drive Q4 2026 net product revenue guidance of $30.0 million to $32.0
- 1w agoDNLIThird Quarter 2026 Financial Results and Business Highlights - DENALI THERAPEUTICS INCEarnings Call TranscriptsGood day, and thank you for standing by. Welcome to Denali Therapeutics' third quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will
- 1w agoDNLIDenali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH® (tividenofusp alfa-eknm) as Best Biotechnology ProductGlobeNewswireFirst FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient careFirst new FDA-approved treatment option
- 2w agoDNLIDenali Therapeutics to Report Third Quarter 2026 Financial Results and Business Highlights on November 3, 2026GlobeNewswireSOUTH SAN FRANCISCO, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that it will report financial results and business highlights for the third quarter ended September
- 1mo agoDNLIMorgan Stanley 24th Annual Global Healthcare Conference - DENALI THERAPEUTICS INCEarnings Call TranscriptsGood afternoon, everyone. I'm Sean Larmond, Head of US Mid-Cap Biotech Equity Research here at Morgan Stanley, and welcome to our Global Healthcare Conference. Before we begin, make you aware of some important disclosure
- 1mo agoDNLIMorgan Stanley 24th Annual Global Healthcare Conference - DENALI THERAPEUTICS INCEarnings Call TranscriptsGood afternoon, everyone. I'm Sean Larmond, Head of US Mid-Cap Biotech Equity Research here at Morgan Stanley, and welcome to our Global Healthcare Conference. Before we begin, make you aware of some important disclosure
- 3mo agoDNLISecond Quarter 2026 Financial Results and Business Highlights - DENALI THERAPEUTICS INCEarnings Call TranscriptsGood day and thank you for standing by. Welcome to the second quarter 2026 Financial Results and Business Highlights. At this time all participants are in a listen only mode. After the speaker's presentation there will b
- 3mo agoDNLIDenali Therapeutics Reports Second Quarter 2026 Financial Results and Business HighlightsGlobeNewswireStrong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenueAdvanced TransportVehicle™ portfolio with two Alzheimer’s disease programs now in clinical
- 3mo agoDNLIDenali Therapeutics to Report Second Quarter 2026 Financial Results and Business Highlights on August 6, 2026GlobeNewswireSOUTH SAN FRANCISCO, Calif., July 27, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that it will report financial results and business highlights for the second quarter ended June 30,
- 4mo agoDNLIDenali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 MillionGlobeNewswireProceeds from transaction to support advancement of Denali's broad TransportVehicle™-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseasesDenali was awarded Priority Review
- 5mo agoBIIBDNLIBiogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson's DiseaseGlobeNewswireThe Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122
- 5mo agoDNLITheo Baker spent four years investigating Stanford. Before he leaves, here’s what he found.TechCrunch
- 6mo agoDNLIDenali Therapeutics Reports First Quarter 2026 Financial Results and Business HighlightsGlobeNewswireFDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrierAVLAYAH launched in U.S. with strong
- 6mo agoALNYARCTDNLIOTLC+1When Science Becomes an Asset: How Advancing Drug Pipelines Are Driving Real-Time Valuation in BiotechGlobeNewswireAUSTIN, 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
- 7mo agoDNLIDenali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)GlobeNewswireDenali 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
- 7mo agoPRMEMDGLIOVADNLIThe $578 Billion Regenerative Medicine Market Has a Manufacturing Problem. One Company Just Solved the First StepPR NewswireThe FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578 billion by 2033. Cell...
- 7mo agoDNLIDenali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)GlobeNewswireFirst 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
- 7mo agoPRMEMDGLIOVADNLIAdvanced Cell-based Therapy Booming the Success for Healthcare SectorPR NewswireUSANewsGroup.com — The FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578...
- 7mo agoDNLIApproval of Avlayah, Bla #761485FDA Approved DrugsApproval Date: 03/24/2026; Drug Name: Avlayah, Bla #761485; Active Ingredients: TIVIDENOFUSP ALFA-EKNM; Company: Denali Therapeutics Inc.; Submission Status: Approval; Application Number: 761485
- 8mo agoWVEDNLIMRNAGMTX+6FDA reversals leave investors worrying about the fates of other experimental drugsCNBCInvestors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.
- 8mo agoDNLIDenali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business HighlightsGlobeNewswireTividenofusp 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
- 9mo agoDNLIDenali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™GlobeNewswireAnalysis 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
- 9mo agoDNLIDenali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™GlobeNewswireSOUTH 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
- 9mo agoDNLIDenali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™GlobeNewswireHunter syndrome (MPS II) presentations will include analysis from continued follow-up of Phase 1/2 data for tividenofusp alfa (DNL310), currently under FDA Priority ReviewPreliminary data from Phase 1/2 study of DNL126
- 10mo agoDNLIThe New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics' Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)GlobeNewswireTividenofusp alfa treatment showed reduction and normalization in key disease biomarkers, stabilization or improvement in clinical endpoints including adaptive behavior, cognition and hearing, and normalization of liver
- 11mo agoDNLIDenali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded WarrantsGlobeNewswireSOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the pricing of its underwritten public offering of 9,142,857 shares of its common stock at a price
- 11mo agoDNLIDenali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded WarrantsGlobeNewswireSOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common
- 11mo agoDNLIRPRXRoyalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding AgreementGlobeNewswireNEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) and Denali Therapeutics, Inc. (NASDAQ:DNLI) today announced a $275 million synthetic royalty funding
- 11mo agoDNLIRPRXDenali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding AgreementGlobeNewswireSOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) and Royalty Pharma plc (NASDAQ:RPRX) today announced a $275 million synthetic royalty funding agreement
- 1y agoDNLIDenali Therapeutics Reports Third Quarter 2025 Financial Results and Business HighlightsGlobeNewswireTividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting
- 1y agoDNLIDenali Therapeutics Announces Board and Executive Leadership UpdatesGlobeNewswireSOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced updates to its Board of Directors and executive leadership team. Tim Van Hauwermeiren has been
- 1y agoDNLIDenali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)GlobeNewswireSOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics
- 1y agoDNLIDenali Therapeutics Inc. (DNLI) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference TranscriptEarnings Call Transcripts
- 1y agoDNLIDenali Therapeutics Reports Second Quarter 2025 Financial Results and Business HighlightsGlobeNewswireTividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launchDNL126 accelerated approval path for Sanfilippo
- 1y agoDNLIDenali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)GlobeNewswireFDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approvalTividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brainTividenofusp
- 1y agoDNLIDenali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter SyndromeGlobeNewswireSOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "The
- 1y agoDNLIDenali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START ProgramGlobeNewswireRolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment through recent interactions with CDER on path to accelerated
- 1y agoDNLIDenali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business HighlightsGlobeNewswireSOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business
- 1y agoDNLIDenali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp AlfaGlobeNewswireLong-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behaviorLong-term safety data
- 1y agoDNLIDenali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™GlobeNewswireSOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which
- 1y agoDNLIDenali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage DiseasesGlobeNewswireFDA Breakthrough Therapy Designation received for tividenofusp alfa for Hunter syndrome (MPS II); on track to submit biologics license application (BLA) in early 2025Preparing for commercial launch of tividenofusp alfa
- 1y agoDNLIDenali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)GlobeNewswireSOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for
- 1y agoDNLIDenali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform TrialGlobeNewswirePrimary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeksOverall, DNL343 was found to be safe and well
- 1y agoDNLIDenali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson's DiseaseGlobeNewswireSOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug
- 2y agoDNLIDenali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)GlobeNewswireRecent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics license application (BLA) early in 2025 under the accelerated
- 2y agoDNLIDenali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous AdministrationGlobeNewswireSOUTH SAN FRANCISCO, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain
- 2y agoDNLIDenali Therapeutics Reports Second Quarter 2024 Financial Results and Business HighlightsGlobeNewswireSOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain
- 2y agoDNLIFHTXMRNAOMGA+2Flagship Pioneering and ProFound Therapeutics Announce Agreement to Identify Novel First-in-Class Therapeutics for the Treatment of Obesity under Strategic Partnership with PfizerPR NewswireFlagship Pioneering and ProFound™ Therapeutics, a Flagship-founded company pioneering the expanded human proteome to develop novel medicines for a...
- 2y agoDNLIDenali Therapeutics Announces FDA Has Selected DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo Syndrome Type A) for START Pilot Program Intended to Accelerate Development of Rare Disease TherapiesGlobeNewswireSTART is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological products for rare diseasesDNL126 was selected as one of three