Applied Therapeutics, Inc. (Nasdaq: APLT) has announced significant leadership changes and provided updates on its strategic direction. John H. Johnson, a seasoned biopharmaceutical executive, has been appointed as Executive Chairman, while Les Funtleyder, the company's Chief Financial Officer, will serve as Interim Chief Executive Officer. These changes are effective immediately.
Leadership Transition
John H. Johnson brings over 40 years of experience in the pharmaceutical and biotechnology industries, having held leadership positions at Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc. His expertise includes implementing turnaround plans and driving value creation for shareholders. Dr. Teena Lerner, Applied Therapeutics’ Lead Independent Director, expressed confidence that Johnson's experience with pre-commercial businesses and deep knowledge of rare diseases would greatly benefit the company.
Les Funtleyder, who has been a member of the board since 2016 and CFO since November 2023, will take on the role of Interim CEO. Funtleyder has a strong understanding of Applied Therapeutics' business and operations, and the board is confident in his ability to lead the company forward while they search for a permanent CEO.
Govorestat Regulatory Pathway
Applied Therapeutics is currently evaluating its response to the Complete Response Letter (CRL) received from the FDA for the New Drug Application (NDA) for govorestat in the treatment of Classic Galactosemia. The company has also withdrawn its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for govorestat (AT-007) for the same indication, citing the need for additional data to support a European MAA.
The company is also closely examining the ongoing Sorbitol Dehydrogenase (SORD) Deficiency clinical development program and working with the FDA to determine an appropriate regulatory pathway for govorestat in this indication. The company anticipates submitting an NDA for govorestat for the treatment of SORD Deficiency after the first quarter of 2025.
Commitment to SORD Deficiency Program
Despite recent regulatory setbacks, Applied Therapeutics remains committed to the development of govorestat for SORD Deficiency, a rare neuromuscular disease with no FDA-approved treatments. The company believes in the clinical value of govorestat and its potential to slow disease progression in patients with SORD Deficiency. The company is working to provide the FDA with support for the potential use of the accelerated approval pathway for govorestat for the treatment of SORD Deficiency.
Mr. Funtleyder stated, “While we complete the important work to best position govorestat, we are focused on execution and ensuring the highest standards of integrity and quality. SORD Deficiency is a rare neuromuscular disease with no FDA-approved drugs, and it remains highly attractive in terms of unmet need, key opinion leader support and commercial potential. We continue to believe in the clinical value of govorestat and remain committed to the prospect of providing patients with a treatment option that has the potential to slow disease progression.”
