Scynexis shares surge 10.62% intraday after receiving FDA QIDP and Fast Track designations for SCY-247 and resuming Phase 3 MARIO study dosing.

SCYNEXIS surged 10.62% intraday following news of FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for its antifungal candidate SCY-247, announced 2 days prior. These regulatory milestones validate the drug’s potential to address unmet medical needs, enhancing investor confidence. Additionally, the resumption of Phase 3 MARIO study dosing for Brexafemme after an 18-month FDA hold, coupled with a $10M milestone payment from GSK, underscored operational progress. Recent presentations at medical conferences and participation in investment events further highlighted SCY-247’s therapeutic promise, attracting market attention. While a Simply Wall St analysis raised concerns about cash burn, the immediate catalysts centered on regulatory and clinical advancements, aligning with the stock’s sharp intraday rally.