Applied Therapeutics(APLT) - 2023 Q4 - Annual Results
Applied Therapeutics(APLT)2024-03-05 16:00
Exhibit 99.1 Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results - NDA for govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia; PDUFA target action date of August 28, 2024; MAA under review by EMA with decision expected in 4Q 2024 - Announced positive results from 12-month interim analysis of govorestat in ongoing INSPIRE Phase 3 trial in SORD Deficiency; Company plans to request pre-NDA meeting with neurology division of FDA - Strengt ...