Applied Therapeutics Surges 70.5% on FDA Meeting Update

Applied Therapeutics shares soared 70.5% after the FDA canceled an Advisory Committee meeting for the NDA of govorestat. This decision signals a higher likelihood of FDA approval, positively impacting investor sentiment and stock performance.

Date: 18-09-2024

AI Rating: 7

Applied Therapeutics (NASDAQ: APLT) has experienced a significant surge in its stock price by 70.5% due to a pivotal decision by the FDA. The FDA canceled an Advisory Committee meeting that was initially scheduled for October 9, 2024, regarding the company's New Drug Application (NDA) for govorestat, aimed at treating galactosemia, a rare genetic disorder.

This cancellation suggests that the FDA may have confidence in the NDA, allowing for a more straightforward approval process without the usual external expert evaluation. Generally, Advisory Committee meetings increase the risk of non-approval; thus, their cancellation often leads to an increased probability of a favorable outcome.

The FDA has set a Prescription Drug User Fee Act (PDUFA) date for November 28, 2024. This timeline provides Applied Therapeutics with a clearer path towards potential FDA approval, which would be a substantial milestone for the company and could further enhance investor confidence.

While the report does not detail any specific financial metrics such as Earnings Per Share (EPS), Revenue Growth, Net Income, Profit Margins, Free Cash Flow, or Return on Equity (ROE), the lack of negative financial indicators at this time is a positive sign for investors.

Additionally, the prospective pipeline for govorestat in treating other metabolic conditions such as SORD deficiency creates further opportunities for growth. Overall, the cancellation of the Advisory Committee meeting markedly improves both the likelihood of regulatory approval and the potential market performance of Applied Therapeutics.

Stocks: APLT