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On August 26, 2026, Celcuity Inc. submitted a supplemental New Drug Application to the U.S. Food and Drug…
CELCCelcuity Inc.
On August 26, 2026, Celcuity Inc. submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for REVTORPYK (gedatolisib) to treat hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutations following progression on endocrine therapy. The application is supported by Phase 3 VIKTORIA-1 trial data showing the drug reduced disease progression risk by 50% in the mutant cohort compared to alpelisib. REVTORPYK was previously approved for patients without this mutation on July 14, 2026. Celcuity Inc. is a biotechnology company focused on developing and commercializing targeted therapies for solid tumors.