On July 15, Celcuity rose 5.22% in regular trading, trading at $108.84/share, with turnover of $106 million. The rally was driven by the imminent PDUFA target action date of July 17 for the company's core drug candidate gedatolisib, with the market pricing in optimism ahead of a potential FDA approval decision.

The FDA previously accepted Celcuity's new drug application for gedatolisib and granted it priority review designation. The application was submitted under the FDA's Real-Time Oncology Review program, designed to facilitate shorter regulatory review periods. The drug targets hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer.

Detailed Phase 3 Viktoria-1 trial results published in early June showed 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. Objective response rates were 48.9% versus 35.7%, and the treatment was generally well tolerated with mostly low-grade adverse events. The company has indicated it is preparing for potential commercial launch in the third quarter.

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