Denali Therapeutics shares fall 3.52% intraday after reporting mixed Q2 2025 results and regulatory updates.

Denali Therapeutics Inc. declined 3.52% in intraday trading. The company reported several updates, including the acceptance of a BLA for Tividenofusp alfa for Hunter syndrome with a PDUFA target action date of January 5, 2026, and the alignment of DNL126's accelerated approval path for Sanfilippo syndrome Type A with the FDA. Additionally, the company is preparing for a global Phase 3 confirmatory study and plans to submit regulatory applications in 2025 for one to two additional TransportVehicleTM-enabled programs. Preclinical research on the ATV:Abeta program for Alzheimer’s disease was also published in the journal Science.