On July 15, Celcuity Inc declined 22.15% in regular trading, trading at $90.83/share, with turnover of $55.63 million. The sharp decline came after the FDA formally approved the company's core drug REVTORPYK (gedatolisib) for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer, based on Phase 3 VIKTORIA-1 trial data.

The stock had already rallied significantly in anticipation of the PDUFA target date of July 17, rising over 5% intraday to $109.21 earlier in the session. Upon formal approval, investors engaged in aggressive profit-taking in a textbook sell-the-news pattern. Additionally, the approved indication is limited to PIK3CA wild-type patients only, with the supplemental application for PIK3CA-mutant patients not expected until Q3, narrower than some market expectations, which intensified selling pressure.

The VIKTORIA-1 trial demonstrated that the gedatolisib triplet reduced the risk of disease progression or death by 50%, with median progression-free survival of 11.1 months versus 5.6 months for the comparator. The company plans to initiate commercialization by end of Q3.

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