Applied Therapeutics Inc

Applied Therapeutics Inc. announced leadership changes, appointing John H. Johnson as Executive Chairman and Les Funtleyder as Interim CEO. The company faces regulatory hurdles, including delays in drug applications, but remains focused on advancing its drug candidate portfolio, particularly govorestat for rare metabolic diseases.

Applied Therapeutics Inc. received a CRL from the FDA for govorestat, aimed at treating Classic Galactosemia, due to clinical deficiencies. The company plans to discuss resubmission or appeal, highlighting govorestat's potential benefits and safety profile. It's also developing govorestat for SORD Deficiency, with an NDA expected in 2025. Galactosemia affects thousands, with no current treatments. Applied Digital reported strong fiscal Q1 revenue and financial improvements.

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah, targeting hemophilia, gastric cancers, and UTIs respectively. November anticipates FDA decisions on drugs like Journey Medical's DFD-29 for rosacea, Merus' Zenocutuzumab for NRG1+ cancers, and PTC Therapeutics' Upstaza for AADC deficiency, among others, highlighting significant advancements in treatment options.