Applied Therapeutics, Inc. (APLT), a biopharmaceutical firm, announced on Friday that Shoshana Shendelman has resigned from her roles as Chair and CEO. Les Funtleyder, the company's Chief Financial Officer, has been appointed as the interim CEO.
John Johnson, a seasoned industry professional with previous experience at Eli Lilly, Pfizer, Johnson & Johnson, and ImClone, will assume the position of executive chairman.
In light of the leadership transition, Applied Therapeutics is reevaluating the Complete Response Letter issued by the FDA in November concerning Govorestat, a treatment aimed at Classic Galactosemia. Consequently, the company has withdrawn its Marketing Authorization Application (MAA) for Govorestat or AT-007 from the European Medicines Agency. The firm noted that additional data collection is necessary to support future MAA submissions in Europe.
Additionally, Applied Therapeutics is reviewing its clinical program for Sorbitol Dehydrogenase Deficiency (SORD) and is collaborating with the FDA to determine the data required for approval. This includes investigating the potential use of the accelerated approval pathway. The company intends to submit a New Drug Application (NDA) for Govorestat to treat SORD after the first quarter of 2025.
On Thursday, APLT's share price closed at $1.02 on the Nasdaq, reflecting a 5.56% decline. In pre-market trading, the stock further decreased by 7.82% to $0.94.
