Recent Updates — CELC
On September 30, 2026, Celcuity Inc. announced that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy. The drug was previously approved by the FDA on July 14, 2026, in combination with palbociclib and fulvestrant (triplet) or solely with fulvestrant (doublet). Clinical data from the Phase 3 VIKTORIA-1 trial demonstrated that REVTORPYK reduced the risk of disease progression or death by 76% for the triplet regimen and 67% for the doublet compared to fulvestrant in PIK3CA wild-type patients. The company has launched a patient support program to assist with insurance coverage, reimbursement, and financial assistance. Celcuity Inc. is a biotechnology company focused on developing and commercializing targeted therapies for solid tumor indications.
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.