FDA delays approval of Applied Therapeutics’ govorestat

The US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) as a treatment of classic galactosemia by three months, said USA-based rare disease firm Applied Therapeutics (Nasdaq: APLT)

The FDA has now set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024, compared with the previous action date of August 28, and news of the delay saw Applied’s shares plummet more than 15% to $5.77 in after-hours trading on Thursday.

Applied noted that the FDA notified the company that it required additional time to review supplemental analyses of previously submitted data that had been provided by Applied in response to the FDA’s routine information requests and determined that the additional information constitutes a Major Amendment to the NDA. In February 2024, the company announced that the FDA accepted and granted Priority Review to the NDA. Govorestat was previously granted Pediatric Rare Disease designation, and will qualify for a Priority Review Voucher (PRV) upon approval.