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January 29, 2026 16:00 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™

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 ReviewPreliminary data from Phase...
January 06, 2026 08:00 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome

Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter syndromeExpecting multiple clinical data readouts from...
December 30, 2025 08:00 ET | Source: Denali Therapeutics Inc.

The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)

Tividenofusp alfa treatment showed reduction and normalization in key disease biomarkers, stabilization or improvement in clinical endpoints including adaptive behavior, cognition and hearing, and...
December 10, 2025 00:14 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

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...
December 09, 2025 16:01 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants

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...
December 04, 2025 07:00 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement

SOUTH 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...
November 06, 2025 16:01 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

Tividenofusp 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...
November 06, 2025 16:00 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces Board and Executive Leadership Updates

SOUTH 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...
October 13, 2025 16:01 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)

SOUTH 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...
August 11, 2025 16:01 ET | Source: Denali Therapeutics Inc.

Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights

Tividenofusp 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...