
Leadership Changes - Shoshana Shendelman has stepped down as CEO of Applied Therapeutics, Inc., with Les Funtleyder appointed as Interim CEO [1][19] - John H. Johnson has been named Executive Chairman, bringing over 40 years of experience in the biopharmaceutical industry [19][23] - Les Funtleyder has been with the company since June 2016 and has served as CFO since November 2023, providing continuity in leadership [2][14] Business Updates - The company has withdrawn its Marketing Authorization Application (MAA) for govorestat for the treatment of Classic Galactosemia, citing the need for more data [4] - Following a Complete Response Letter (CRL) received in November 2024 regarding the New Drug Application (NDA) for govorestat, the company is evaluating its response and potential next steps with the FDA [12][13] - The company plans to submit an NDA for govorestat for the treatment of Sorbitol Dehydrogenase (SORD) Deficiency after the first quarter of 2025 [13] Compensation and Incentives - The Compensation Committee approved inducement awards for Mr. Johnson, including stock options for 2,000,000 shares and restricted stock units for 1,000,000 shares, with specific vesting conditions tied to regulatory approvals [5] Company Vision and Strategy - The leadership transition is viewed as a strategic move to align with the company's priorities in developing treatments for rare diseases [10] - Mr. Funtleyder emphasized the importance of maintaining high standards of integrity and quality while focusing on the clinical pipeline [22]