FDA Cancels Advisory Committee Meeting for Applied Therapeutics’ Govorestat, Stock Surges 65%

FDA Decision:
The FDA has canceled an Advisory Committee meeting scheduled for October 9, 2024, to review Applied Therapeutics' New Drug Application (NDA) for govorestat, a treatment for Classic Galactosemia.

Stock Impact:
Following the announcement, Applied Therapeutics' stock (APLT) surged by 65% to 70.5% on Wednesday, September 18, 2024.

Priority Review:
The FDA's Priority Review of the NDA for govorestat continues as planned, with alignment on post-marketing requirements expected in October 2024 and a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.

Market Potential:
Analysts predict a successful rollout of govorestat due to the high unmet medical need, absence of other approved therapies, and well-identified patient population, with estimated 2030 sales exceeding $1 billion.

Clinical Trials:
Applied Therapeutics is also exploring govorestat in a late-stage clinical trial for Sorbitol Dehydrogenase (SORD) deficiency, another rare genetic metabolic condition.