Govorestat
Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection
Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
FDA Rejects Applied Therapeutics’ Rare Disease Drug Govorestat, Citing Clinical Application Deficiencies
Applied Therapeutics, FDA rejection, govorestat, galactosemia, rare metabolic disease, clinical application deficiencies
FDA Rejects Govorestat for Classic Galactosemia, Citing Clinical Deficiencies
FDA rejection, govorestat, classic galactosemia, Applied Therapeutics, rare disease drug approval, clinical deficiencies
FDA Cancels Advisory Committee Meeting for Applied Therapeutics’ Govorestat, Stock Surges 65%
Applied Therapeutics, FDA, Advisory Committee, Govorestat, Galactosemia, Stock Surge
Applied Therapeutics Stock Surges After FDA Cancels Advisory Meeting for Govorestat
Applied Therapeutics, FDA, Govorestat, Advisory Meeting, Classic Galactosemia, Stock Surge