SCYNEXIS Receives FDA QIDP and Fast Track Designations for SCY-247

SCYNEXIS announces the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for SCY-247, an investigational antifungal therapy, on January 21, 2026. The designations support development of SCY-247 for treating invasive fungal infections, which the company says have limited treatment options and high mortality rates. QIDP status, under the Generating Antibiotic Incentives Now (GAIN) Act, provides eligibility for priority review and an additional six months of market exclusivity upon approval. Fast Track designation enables expedited review and more frequent interactions with the FDA during development. SCY-247 is a novel oral glucan synthase inhibitor designed to target difficult-to-treat fungal pathogens, including Candida and Aspergillus species. SCYNEXIS plans to advance the candidate into later-stage clinical trials in 2026.