On June 2, Celcuity fell 23.24% in regular trading, trading at approximately $93.41/share, with trading volume of $320 million. The decline came after the company disclosed detailed Phase III VIKTORIA-1 trial results for the PIK3CA-mutant cohort via an SEC filing.

The data showed that the Gedatolisib triple therapy achieved a median progression-free survival (mPFS) of 11.1 months versus 5.6 months for the Alpelisib plus Fulvestrant control arm. The safety profile was favorable, with most adverse events classified as low-grade. Additionally, the FDA has granted priority review designation for the Gedatolisib new drug application, setting a PDUFA target action date of July 17. The company indicated it is on track for a potential commercial launch in Q3 if approved.

Despite objectively positive clinical and regulatory milestones, the sharp selloff suggests the market had already priced in a favorable outcome or harbored even higher expectations for the efficacy data, triggering a classic sell-the-news reaction.

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