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.
