BRIEF-Denali Therapeutics Announces Initiation Of BLA Filing For Accelerated Approval Of Tividenofusp Alfa For Treatment Of Hunter Syndrome

Reuters

2025/04/02

BRIEF-Denali <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces Initiation Of BLA Filing For Accelerated Approval Of Tividenofusp Alfa For Treatment Of Hunter Syndrome

April 2 (Reuters) - Denali Therapeutics Inc DNLI.O:

DENALI THERAPEUTICS ANNOUNCES INITIATION OF BLA FILING FOR ACCELERATED APPROVAL OF TIVIDENOFUSP ALFA FOR TREATMENT OF HUNTER SYNDROME (MPS II) AND POSITIVE ONGOING INTERACTIONS WITH FDA ON DNL126 THROUGH START PROGRAM
DENALI THERAPEUTICS : EXPECTS TO COMPLETE BLA SUBMISSION IN FIRST HALF OF MAY 2025
DENALI THERAPEUTICS INC: CONTINUES TO PREPARE FOR A POTENTIAL COMMERCIAL LAUNCH IN U.S. IN LATE 2025 OR EARLY 2026

Source text: ID:nGNX7SFxct

Further company coverage: DNLI.O

(((( Reuters.briefs@thomsonreuters.com ;));))

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