Denali Therapeutics (NASDAQ:DNLI) is seeing early commercial interest for its first approved drug, AVLAYAH, following its March 24 accelerated approval for Hunter syndrome, Chief Operating Officer and...
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....
Barchart Research What to Expect from DNLI Earnings DNLI Generated May 4, 2026 Current Price $18.67 EPS Estimate $$-0.73 Consensus Rating Strong Buy Average Move 5.31% Denali's First Commercial Quarter...
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...
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...
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...
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...
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...
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™...
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...