On July 15, Celcuity Inc fell 5.45% overnight, trading at $105.0/share, with turnover of $4,229.8. The decline followed FDA formal approval of the company's core drug REVTORPYK for HR+/HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer.

The approval was based on the Phase 3 VIKTORIA-1 trial, in which median progression-free survival reached 9.3 months with the REVTORPYK triplet combination versus 2.0 months with fulvestrant alone. However, the stock had already surged over 5% intraday ahead of the approval as the PDUFA target date of July 17 approached, prompting a typical profit-taking selloff once the positive catalyst materialized.

Additionally, the current approval covers only PIK3CA wild-type patients. A supplemental application for the PIK3CA-mutated population is expected to be submitted in the third quarter, creating a potential expectation gap regarding the breadth of the approved indication. Celcuity plans a commercial launch in late third quarter.

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