Denali Therapeutics Announces FDA Review Extension for Tividenofusp Alfa in Hunter Syndrome; New PDUFA Date Set for April 2026

Reuters

Oct 14, 2025

Denali <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces FDA Review Extension for Tividenofusp Alfa in Hunter Syndrome; New PDUFA Date Set for April 2026

Denali Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for its Biologics License Application (BLA) for tividenofusp alfa, a treatment candidate for mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date has been moved from January 5, 2026, to April 5, 2026, following Denali's submission of updated clinical pharmacology information at the FDA's request. The extension is not related to efficacy, safety, or biomarkers, and no additional data were requested. Denali continues preparing for potential approval and commercial launch of the therapy.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Denali Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9544684-en) on October 13, 2025, and is solely responsible for the information contained therein.

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