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.

Celcuity Inc. reported financial results for the quarter ended June 30, 2026, posting a net loss of $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million in the prior year period. The company completed a public offering of convertible senior notes due 2032, generating net proceeds of $557.2 million, which were partially used to prepay $137.0 million in term loan debt. Commercially, Celcuity received FDA approval on July 14, 2026, for REVTORPYK (gedatolisib) to treat HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer and is on track for a commercial launch in late Q3 2026. Additionally, the Phase 3 VIKTORIA-1 trial's PIK3CA mutant cohort achieved its primary endpoint, prompting plans to submit a supplemental New Drug Application in Q3 2026. Celcuity Inc. is a biotechnology company focused on developing and commercializing targeted therapies for solid tumor indications.

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.