Celcuity Secures FDA Green Light for Breast Cancer Breakthrough

After two decades of research into the elusive PAM pathway, Celcuity has received FDA approval for Revtorpyk, a novel treatment for HR+/HER2- breast cancer. The drug, known generically as gedatolisib, marks a significant shift in therapy for patients who have exhausted initial endocrine options without specific PIK3CA mutations.

July 15, 2026, 12:41 AM 1,001 0

Celcuity Secures FDA Green Light for Breast Cancer Breakthrough

CEO Brian Sullivan described the drug as a milestone, noting that Revtorpyk serves as the first pan-PI3K, mTORC1/2 inhibitor to clear federal regulators. By targeting the PI3K/AKT/mTOR pathway, the treatment addresses a biological mechanism that has long frustrated oncologists and drug developers. The company plans to initiate a commercial launch late in the third quarter of this year.

Beyond the initial approval, Celcuity intends to file a supplemental application targeting patients who harbor PIK3CA mutations. The drug is simultaneously undergoing a phase 3 clinical trial aimed at treatment-naive patients. Investors reacted to the news on Tuesday, driving shares up 7% to $111.05 before the stock dipped 5.5% in after-hours trading.

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