FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026

Denali Therapeutics Inc.

FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.
Extension follows submission of updated clinical pharmacology info; FDA classified as Major Amendment.
Denali states extension not related to efficacy, safety, or biomarkers; no additional data requested.
Denali continues preparing for potential approval and commercial launch of tividenofusp alfa.

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