Celcuity wins FDA approval for REVTORPYK in advanced breast cancer

Celcuity Inc. received full approval from the US Food and Drug Administration for its drug gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, the company said Wednesday.

The approval marks Celcuity's transition from a clinical-stage biotechnology company to a commercial-stage business, the Minneapolis-based firm said in a statement. The company did not disclose the specific patient population or biomarker requirements for the indication.

"REVTORPYK represents a new treatment option for patients with advanced breast cancer who have limited alternatives," the company said. Celcuity did not provide details on the pivotal trial that supported the approval, including efficacy endpoints such as progression-free survival or overall survival rates.

The FDA's decision follows a standard review timeline. Celcuity has not yet disclosed pricing for REVTORPYK or peak sales estimates for the drug. The company's pipeline includes additional candidates targeting PI3K and mTOR pathways in oncology.

The approval positions Celcuity to compete in the advanced breast cancer market, which includes established therapies from Pfizer, Novartis, and Eli Lilly. Celcuity did not provide revenue guidance or a commercial launch timeline.

Shares of Celcuity (CELC) are expected to open higher Wednesday as the market prices in the company's transition to a revenue-generating business. The company's next catalyst will be its first quarterly earnings report as a commercial-stage firm, where investors will see initial REVTORPYK sales figures.

This article is for informational purposes only and does not constitute investment advice.