On July 9, Celcuity declined 5.37% in regular trading, trading at approximately $110.27/share, with turnover of $56.25 million. The stock had risen 5.02% in the prior session.

The pullback comes as the FDA's Prescription Drug User Fee Act (PDUFA) target action date for the company's core drug candidate gedatolisib is set for July 17, now less than 10 days away. The binary nature of the upcoming regulatory decision has intensified bull-bear positioning, triggering sharp intraday reversals. Gedatolisib has received FDA priority review designation for the treatment of HR+/HER2-/PIK3CA-mutated advanced breast cancer. Phase 3 Viktoria-1 trial data demonstrated the gedatolisib triplet regimen reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant, with median progression-free survival of 11.1 months compared to 5.6 months in the control arm. The drug showed generally favorable tolerability, with most adverse events being low-grade. If approved, the company has indicated plans for commercial launch in the third quarter.

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