Brief: Denali Therapeutics Announces Initiation Of BLA Filing For Accelerated Approval Of Tividenofusp Alfa For Treatment Of Hunter Syndrome
02/04/2025 13:02
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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