Brief: Denali Therapeutics Announces FDA Review Extension Of BLA For Tividenofusp Alfa
13/10/2025 21:18
Oct 13 (Reuters) - Denali Therapeutics Inc DNLI.O: DENALI THERAPEUTICS ANNOUNCES FDA REVIEW EXTENSION OF BLA FOR TIVIDENOFUSP ALFA FOR THE TREATMENT OF MPS II (HUNTER SYNDROME) PDUFA DATE EXTENDED TO APRIL 5, 2026 NO ADDITIONAL DATA WERE REQUESTED BY FDA IN MA LETTER BELIEVES UPDATED INFORMATION SUBMITTED IN AMENDMENT DOES NOT AFFECT CLINICAL PHARMACOLOGY OR BENEFIT-RISK CONCLUSIONS OF BLA Source text: ID:nGNX9vDvgk Further company coverage: DNLI.O ((Reuters.Briefs@thomsonreuters.com;))
Recent news on Denali Therapeutics
See all newsDenali Therapeutics Inc. reports results for the quarter ended June 30 - Earnings Summary
Denali Therapeutics Q2 net loss widens as AVLAYAH launch costs rise
Biogen's Alzheimer's drug lowers toxic protein, but results were mixed
U.S. STOCKS ON THE MOVE-Sweetgreen, Dell Technologies, Peloton Interactive
U.S. STOCKS ON THE MOVE-IMAX, Novo Nordisk, PC makers