2026-07-15 from globalnews.ca

The U.S. FDA has approved Celcuity’s drug for an advanced form of breast cancer, the regulator said on Tuesday, making it the company’s first product to gain market entry and sending its shares up seven per cent in afternoon trading.

The U.S. Food and Drug Administration’s approval was based on late-stage data showing the drug, gedatolisib, branded as Revtorpyk, when combined with Pfizer’s Ibrance and fulvestrant, reduced the risk of disease progression or death by 76 per cent compared with fulvestrant alone.

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