Applied Therapeutics faces a class-action lawsuit alleging misleading information about its govorestat clinical trials. The FDA issued a Complete Response Letter rejecting the drug’s application and a warning letter citing data capture and dosing errors. The company’s stock plummeted, and leadership changes were announced. An analyst downgraded the stock, reflecting significant market concerns.
Applied Therapeutics’ New Drug Application (NDA) for govorestat, a potential treatment for Classic Galactosemia, was rejected by the FDA. While the reasons remain unclear, this unexpected setback significantly impacts APLT stock and the future of the drug. However, the company’s ongoing SORD program remains unaffected and offers a potential path to future revenue.
Applied Therapeutics’ stock price surged after the company received positive news from the FDA regarding its New Drug Application (NDA) review for govorestat, a potential treatment for Classic Galactosemia. The FDA has confirmed that an advisory committee meeting is no longer necessary, and the priority review of the NDA remains on track.
