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.
In section Market Quotes
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.
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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