Celcuity Inc. announced on July 14, 2025, the issuance of U.S. Patent No. 12,350,276, which covers the clinical dosing regimen for its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients. This patent extends Celcuity’s patent exclusivity in the U.S. into 2042.
The new patent strengthens Celcuity's intellectual property portfolio for gedatolisib, which now includes 13 granted U.S. patents and 290 patents granted in foreign jurisdictions. This comprehensive protection is crucial for optimizing the long-term development and commercialization of the drug.
The extended patent exclusivity provides a long runway for Celcuity to maximize the value of gedatolisib, particularly as the company approaches key clinical milestones. The company expects to announce topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in Q3 2025.
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