The FDA extended its review of Denali Therapeutics’ application for tividenofusp (tivi), an enzyme replacement therapy for Hunter syndrome, issuing a three‑month delay that moves the PDUFA date to April 5, 2026. Denali characterized the agency’s action as a procedural response to what the company called an updated clinical pharmacology submission classified by the FDA as a major amendment. Denali said the amendment did not change efficacy or safety data and believes the extension is a technicality. Analysts noted the delay followed Denali flagging an incorrect molecular weight on a public source used in pharmacokinetic analyses, prompting the FDA to request updated information directly from the company. Denali said it remains prepared for potential approval and commercial launch pending the agency’s final determination.