Celcuity's Revtorpyk approval fuels blockbuster expectations

US biotech Celcuity Inc. (NASDAQ: CELC) received U.S. Food and Drug Administration approval for Revtorpyk (gedatolisib) in breast cancer on July 14, marking the company's first commercial product and its transition from a clinical-stage to a commercial-stage biotech. The drug is approved for previously treated patients with hormone receptor-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer. Celcuity is also seeking to broaden the label to patients with PIK3CA mutations, with a supplemental FDA application planned for the third quarter following positive late-stage trial results.

Visible Alpha consensus suggests analysts see Revtorpyk as a potential blockbuster with the capacity to reshape the treatment landscape in second-line breast cancer. With the launch expected in the third quarter, analysts forecast second-line (2L) Revtorpyk revenue of $30 million in 2026, rising tenfold to $300 million in 2027 before surpassing $1 billion annually by 2029. Third-line (3L) use is projected to contribute an additional $23 million this year, increasing to $151 million next year. In oncology, 1L, 2L, and 3L refer to the line of therapy, or the sequence of treatments a patient receives as their disease progresses.

Celcuity is also evaluating Revtorpyk in the first-line (1L) metastatic setting through its Phase 3 VIKTORIA-2 trial. Success in moving the therapy into earlier treatment could substantially expand its addressable market, as first-line therapy represents the largest segment of patients with advanced hormone receptor-positive breast cancer.

 This article was published by Visible Alpha, part of S&P Global Market Intelligence and not by S&P Global Ratings, which is a separately managed division of S&P Global.