Applied Therapeutics CEO Steps Down, Les Funtleyder Appointed As Interim CEO

Applied Therapeutics

0.88 USD -13.29%

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(RTTNews) - Applied Therapeutics, Inc. (APLT), a biopharmaceutical company, Friday announced that Shoshana Shendelman has stepped down as Chair and CEO. The company named its Chief Financial Officer Les Funtleyder as interim CEO.

Biopharmaceutical industry veteran John Johnson will be the new executive chairman. He had previously worked at Eli Lilly, Pfizer, Johnson & Johnson and ImClone.

Further to the leadership changes, Applied Therapeutics will assess the Complete Response Letter received in November from FDA, regarding Govorestat, intended to treat Classic Galactosemia. Following the receipt of a Complete Response Letter, the Company had decided to withdraw its Marketing Authorization Application or MAA for Govorestat or AT-007 from the European Medicines Agency. The company also opined that more time is needed to gather additional data to support a future MAA submission in Europe.

Applied Therapeutics said it is reviewing clinical program for Sorbitol Dehydrogenase Deficiency or SORD and working with the FDA on the data needed for approval, including exploring the use of the accelerated approval pathway. The company now plans to submit an NDA for Govorestat to treat SORD after the first quarter of 2025.

Thursday, APLT had closed 5.56% less at $1.02 on the Nasdaq. In the pre-market trading, APLT is 7.82% less at $0.94.