Celcuity shares fall as launch delay eclipses US approval for breast…

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. You've got regulatory clearance but a practice problem: 22% of patients will drop out because of mouth sores, and managing that side effect becomes your real market access gate. The next founder to win here isn't in cancer biology—it's in supportive care or digital adherence.