FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor ...

In April 2025, Denali announced productive collaboration and discussions with the FDA under the START program (“Support for clinical Trials Advancing Rare Disease Therapeutics”) around the potential ...

This biotech develops therapies for neurodegenerative diseases, advancing a broad pipeline through strategic pharmaceutical partnerships.

This biotech company develops therapies for neurodegenerative and rare diseases, supported by clinical assets and pharma collaborations.

Tividenofusp alfa (DNL310): Enzyme Transport Vehicle (ETV)-enabled, iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome) In October, Denali was informed 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 ...

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) today reported financial results for the third quarter ended September 30, 2025, and provided business ...

Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle™ (OTV)-enabled DNL628 (OTV:MAPT) targeting ...

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