On July 15, Celcuity Inc fell 5.59% in pre-market trading, trading at $104.84/share, with turnover of $90,100.

On the news front, the FDA officially approved Celcuity's core drug REVTORPYK (gedatolisib) for treating HR+/HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer, based on Phase 3 VIKTORIA-1 trial data showing median progression-free survival of 9.3 months versus 2.0 months with fulvestrant alone. However, the stock had already rallied over 5% intraday ahead of the PDUFA target date of July 17, prompting a classic sell-the-news reaction once approval was confirmed.

Additionally, the current approval is limited to PIK3CA wild-type patients only. A supplemental application for PIK3CA-mutated patients is expected to be submitted in Q3, creating a potential expectations gap regarding the scope of the approved indication. The company anticipates a commercial launch in late Q3.

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