Press releases from Applied Therapeutics or clinical trial registries

FDA Issues CRL for Applied Therapeutics' Govorestat, Shares Drop 80%, Trading Halted

Nov 27, 2024, 09:15 PM

Applied Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of its drug, Govorestat, intended for the treatment of Classic Galactosemia, a rare genetic metabolic disorder. The FDA cited clinical deficiencies in the application, indicating that the submitted data did not meet the primary endpoints and raised concerns about the relevance of the biomarker used in the study. Govorestat, a central nervous system-penetrant aldose reductase inhibitor, was the company’s first potential commercial product. Following the announcement, shares of Applied Therapeutics dropped significantly, declining by 80% during after-hours trading, and trading was temporarily halted. The company holds $0.67 per share in cash. Analysts suggest that the company may need to conduct another Phase 3 trial to address the FDA's concerns, despite a push from patient advocacy groups.