Scynexis shares surge 21.07% premarket after FDA grants QIDP and Fast Track designations for SCY-247 antifungal.

Scynexis Inc. surged 21.07% in premarket trading following the announcement that the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for its antifungal candidate SCY-247. The QIDP designation ensures at least 10 years of market exclusivity post-approval, while Fast Track status accelerates regulatory review. The drug targets multi-drug-resistant Candida auris, a fungal pathogen highlighted in recent scientific and media reports as a growing public health threat. Preclinical and Phase 1 data demonstrated SCY-247’s efficacy against drug-resistant strains and favorable safety profiles. The company plans to initiate Phase 1 trials for the IV formulation and Phase 2 trials for the oral formulation in 2026. The news aligns with increased investor optimism about SCY-247’s potential to address unmet medical needs and secure market exclusivity, driving the sharp premarket rally.