Applied Therapeutics Undergoes Leadership Change Amid FDA Rejection and Investor Lawsuit

Leadership Change:
Applied Therapeutics has appointed John H. Johnson as Executive Chairman and Les Funtleyder as Interim Chief Executive Officer, following the resignation of Dr. Shoshana Shendelman as Chair and CEO1.

FDA Rejection:
The FDA issued a Complete Response Letter for the New Drug Application (NDA) for govorestat, citing deficiencies in the clinical application, which led to a significant drop in the company's stock price23.

Investor Lawsuit:
A class action lawsuit has been filed against Applied Therapeutics, alleging that the company misled investors regarding the efficacy of govorestat and the Phase III INSPIRE trial results23.

FDA Warning Letter:
The FDA also issued a warning letter to Applied Therapeutics, criticizing the company for failing to provide sufficient information about a dosing error in a pediatric study and for inadequate corrective action plans4.

Business Updates:
The company has announced business updates, including the appointment of new leadership and the continuation of Les Funtleyder as CFO while serving as Interim CEO1.

Sources:

1. https://ir.appliedtherapeutics.com/news-releases/news-release-details/applied-therapeutics-appoints-john-h-johnson-executive-chairman

2. https://www.prnewswire.com/news-releases/investor-notice-robbins-llp-informs-stockholders-of-the-class-action-lawsuit-filed-against-applied-therapeutics-inc-302336878.html

3. https://www.globenewswire.com/news-release/2024/12/18/2999373/0/en/APLT-INVESTOR-ALERT-Robbins-Geller-Rudman-Dowd-LLP-Announces-that-Applied-Therapeutics-Inc-Investors-with-Substantial-Losses-Have-Opportunity-to-Lead-the-Applied-Therapeutics-Class.html

4. https://insider.thefdagroup.com/p/inside-the-fda-warning-letter-over