Brief: Denali Therapeutics Announces Primary Analysis & Long-Term Follow-Up Of Phase 1/2 Study In Hunter Syndrome With Tividenofusp Alfa

Denali Therapeutics

06/02/2025 16:45

Feb 6 (Reuters) - Denali Therapeutics Inc  DNLI.O :
    * DENALI THERAPEUTICS ANNOUNCES PRIMARY ANALYSIS AND
LONG-TERM
FOLLOW-UP OF PHASE 1/2 STUDY IN HUNTER SYNDROME (MPS II) WITH
TIVIDENOFUSP ALFA
    * DENALI THERAPEUTICS: TIVIDENOFUSP ALFA REGULATORY
SUBMISSION FOR
ACCELERATED APPROVAL PLANNED FOR EARLY 2025
    * DENALI THERAPEUTICS: TIVIDENOFUSP ALFA U.S. LAUNCH
PREPARATION
ONGOING TO DELIVER TIVIDENOFUSP ALFA TO FAMILIES WITH MPS II IN
LATE 2025 OR EARLY 2026
    * DENALI THERAPEUTICS INC: LONG-TERM SAFETY DATA 
DEMONSTRATE THAT
TIVIDENOFUSP ALFA WAS GENERALLY WELL TOLERATED

Source text:  ID:nGNX21hgts 
Further company coverage:  DNLI.O 

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