Applied Therapeutics Stock Surges After FDA Cancels Advisory Meeting for Govorestat

FDA Cancels Advisory Meeting:
The FDA has canceled an advisory committee meeting previously scheduled for October 9, 2024, to discuss Applied Therapeutics' New Drug Application (NDA) for govorestat, a treatment for Classic Galactosemia.

Stock Surge: Following the announcement, Applied Therapeutics' stock (NASDAQ:
APLT) surged by 71.40%, closing at $7.97 on Wednesday, with a trading volume significantly higher than usual.

Review Progress:
The FDA confirmed that the Priority Review of the NDA is proceeding as scheduled, with a target action date under the Prescription Drug User Fee Act (PDUFA) set for November 28, 2024.

Market Potential:
Analyst William Blair predicts a successful launch of govorestat in the galactosemia market in 2025, citing significant unmet medical need and lack of other approved treatments. The analyst forecasts that sales of govorestat could surpass $1 billion by 2030, with a peak market penetration of 70% in the galactosemia sector.

Clinical Data:
The NDA is supported by data from the Phase I/II ACTION-Galactosemia and Phase III ACTION-Galactosemia Kids trials, which demonstrated significant reductions in galactitol levels and clinical benefits in patients with galactosemia.