Denali Therapeutics Faces FDA Delay for Tivizenofusp Alfa, but Long-Term Prospects Remain Strong

The U.S. Food and Drug Administration's (FDA) recent extension of its review timeline for Denali Therapeutics' Biologics License Application (BLA) for tividenofusp alfa—a potential treatment for Hunter syndrome—has sparked scrutiny among investors. The Prescription Drug User Fee Act (PDUFA) target date was pushed back from January 5, 2026, to April 5, 2026, following Denali's submission of updated clinical pharmacology data in response to an FDA information request, according to Denali Therapeutics Announces FDA Review Extension[1