Celcuity Gets FDA Approval for Breast Cancer Drug

By Elias Schisgall

Celcuity received approval from the Food and Drug Administration for Revtorpyk, its breast cancer treatment.

The agency approved the drug, known generically as gedatolisib, to treat patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation following at least one line of endocrine therapy.

Celcuity said Revtorpyk is the first drug of its kind to receive FDA approval.

"The PI3K/AKT/mTOR, or PAM, pathway is one of the most important targets in cancer, but comprehensively inhibiting it has stymied researchers and drug developers for nearly two decades," Chief Executive Officer Brian Sullivan said. "Revtorpyk addressed this 20-year challenge by becoming the first pan-PI3K, mTORC1/2 inhibitor approved by the FDA."

The company is anticipating a commercial launch late in the third quarter.

Around that time, Celcuity also plans to submit a supplemental application for Revtorpyk to treat patients with a PIK3CA mutation, it said Tuesday. Revtorpyk is also being studied in a phase 3 trial for treatment-naive breast cancer patients.

Shares of Celcuity jumped in the last hour of Tuesday's session, closing up 7% at $111.05. The stock fell 5.5% to $104.95 in after-hours trading.

Write to Elias Schisgall at elias.schisgall@wsj.com

Corrections & Amplifications

This headline was corrected at 6:28 p.m. ET. to reflect the proper company name of Celcuity. The original headline misspelled the company name in the headline.

(END) Dow Jones Newswires

July 14, 2026 17:33 ET (21:33 GMT)