Celcuity Inc. announced FDA approval of REVTORPYK (gedatolisib) for treating patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation following progression on endocrine therapy. The approval is based on Phase 3 VIKTORIA-1 trial results, where the REVTORPYK triplet showed a median progression-free survival of 9.3 months compared to 2.0 months for fulvestrant. The company expects a commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application in Q3 2026 for the PIK3CA mutated patient population. Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for solid tumor indications.

Celcuity Inc. announced the FDA approval of REVTORPYK (gedatolisib) for treating HR+/HER2- locally advanced or metastatic breast cancer in patients without a PIK3CA mutation. The company anticipates a commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application (sNDA) in Q3 2026 for the PIK3CA mutated cohort. Celcuity Inc. is a biopharmaceutical company focused on developing precision medicine therapies for cancer.

Celcuity Inc. completed the issuance of $575,000,000 in 0.250% Convertible Senior Notes due 2032, generating approximately $557.0 million in net proceeds. The company also completed a voluntary prepayment of approximately $137.5 million to satisfy and discharge in full all outstanding obligations under its existing Loan Agreement.

Celcuity Inc. announced detailed efficacy and safety results from the PIK3CA mutant-type cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- breast cancer. The gedatolisib-triplet demonstrated a median progression-free survival of 11.1 months and an objective response rate of 48.9%, compared to 5.6 months and 26.0% for alpelisib plus fulvestrant, respectively. The company plans to submit these data to the FDA as a supplemental New Drug Application.