On July 8, Celcuity Inc rose 5.02% in regular trading, trading at $114.055 per share, with turnover of $55.71 million. The stock gained momentum as the FDA Prescription Drug User Fee Act (PDUFA) target action date for its core candidate gedatolisib approaches on July 17, now approximately one week away.

The FDA previously granted priority review to the gedatolisib new drug application, submitted under the Real-Time Oncology Review program for the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. Phase 3 Viktoria-1 trial data demonstrated that the gedatolisib triplet regimen reduced the risk of disease progression or death by 50% compared with Novartis alpelisib plus fulvestrant, nearly doubling median progression-free survival to 11.1 months versus 5.6 months. The doublet regimen achieved median PFS of 11.3 months with objective response rates of 48.9% and 35.7% respectively. Safety data showed generally well-tolerated profiles with mostly low-grade adverse events. The company has indicated it is on track for commercial launch in Q3 if approved.

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