Applied Therapeutics (APLT, Financial) experienced a significant drop in its stock price, opening with a 76% decline, reducing its market value to under $300 million. The stock is currently priced at $2.12 per share.
The sharp decline followed the U.S. Food and Drug Administration's (FDA) decision to reject the approval of Applied Therapeutics' drug, govorestat, intended for treating the rare metabolic disorder, classic galactosemia. The FDA cited deficiencies in the application as the reason for its refusal in a complete response letter.
In response to the FDA's decision, Applied Therapeutics announced that it is reviewing the feedback and plans to request a meeting with the FDA to discuss the requirements for a potential resubmission of the drug application.
