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.

This Wire brief sits within Fusion42's coverage of Digital Health. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.