Celcuity shares fall as launch delay eclipses US approval for breast cancer drug

Celcuity received FDA approval for gedatolisib (Revtorpyk) for advanced breast cancer, but shares fell 19% after the company delayed commercial launch to Q3 and disclosed a safety label showing severe mouth inflammation in 22% of patients on the three-drug combination. The drug achieved 76% risk reduction in disease progression or death versus fulvestrant alone, priced at an estimated $28,000/month.

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