The 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 in idiopathic Parkinson’s disease Denali continues to independently conduct
FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting
Denali plans to continue clinical development of DNL593, which is designed to deliver progranulin to the brain using TransportVehicle™ technology Results 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) --
First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage disease First FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrier Denali’s first medicine enabled by its
Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLD Symposium™, supporting plans to pursue an accelerated approval
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 spectrum Launch readiness established in anticipation of April 5, 2026, Prescription Drug User Fee Act (PDUFA) date for
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 WORLD Symposium ™ being held February
Hunter syndrome (MPS II) presentations will include analysis from continued follow-up of Phase 1/2 data for tividenofusp alfa (DNL310), currently under FDA Priority Review Preliminary data from Phase 1/2 study of DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) to be featured in oral
Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter syndrome Expecting multiple clinical data readouts from pipeline programs including for Sanfilippo syndrome Type A (ETV:SGSH), granulin-related
Tividenofusp 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 volume Most common treatment-related adverse events were infusion-related
SOUTH 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 to the public of $17.50 per share and, in lieu of common stock to certain
SOUTH 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 stock to certain investors, pre-funded warrants to purchase shares of its