Drugmaker Sued Over Optimistic Statements Before FDA Rejection

Applied Therapeutics, Inc. concealed problems with the clinical trial of its metabolic disorder treatment, prompting an 80% stock selloff the week investors learned the FDA wasn’t approving the company’s new drug application, a proposed class action said.

In 2024, the biopharmaceutical company and two key executives touted trial results and confidence in its application to the US Food and Drug Administration for Govorestat, its drug targeting Galactosemia, a rare metabolic disorder that prevents someone from processing sugars found in many founds and dairy products, investor Adrian Alexandru alleged. Applied Therapeutics also announced at the same time it was seeking the ...