Applied Therapeutics Inc. (APLT) stock plummeted 5.14% in pre-market trading on Tuesday, following news that the company received a warning letter from the U.S. Food and Drug Administration (FDA) related to a trial studying its genetic disease drug.
The warning letter comes after the FDA declined to approve the company's treatment for the genetic disease last week, raising concerns over potential regulatory hurdles and setbacks in Applied Therapeutics' drug development plans.
The FDA's warning letter highlights issues with the company's clinical trial processes, which could delay or prevent the approval of its genetic disease treatment. Investors appear to be reacting negatively to this development, driving down Applied Therapeutics' stock price in anticipation of potential further challenges in bringing its drug to market.
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