Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns

Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive, HER2-negative advanced disease without a PIK3CA mutation.

The approval was based on data from the VIKTORIA-1 trial, where Revtorpyk plus fulvestrant and Ibrance kept tumors stable for a median of 9.3 months, compared with 2 months for fulvestrant alone. A doublet of Revtorpyk and Ibrance delayed progression for a median of 7.3 months.

Celcuity expects to begin selling Revtorpyk in the late third quarter of 2026.

Shares of the company fell almost 20% after it disclosed a delay in the drug's launch and prescribing information details that surprised analysts.

Analysts noted that while the regulatory win is positive, the market reaction reflects concerns about timing and commercial execution.