Brief: Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat

Applied Therapeutics

27/11/2024 23:23

Nov 27 (Reuters) - Applied Therapeutics Inc  APLT.O :
    * APPLIED THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER
FROM U.S.
FDA REGARDING NEW DRUG APPLICATION FOR GOVORESTAT FOR CLASSIC
GALACTOSEMIA
    * APPLIED THERAPEUTICS INC - FDA UNABLE TO APPROVE
GOVORESTAT NDA
DUE TO CLINICAL DEFICIENCIES
    * APPLIED THERAPEUTICS INC - EXPECTS TO SUBMIT AN NDA EARLY
IN Q1
OF 2025

Source text:  ID:nGNXZWgTD 
Further company coverage:  APLT.O 

 ((Reuters.Briefs@thomsonreuters.com;))