Celcuity Secures Extended Patent for Breast Cancer Drug, Average Analyst Target Price at $29.00 with 112.77% Upside

Celcuity has secured a new U.S. patent for its breast cancer drug gedatolisib, ensuring market exclusivity through 2042. The company anticipates clinical data readouts from its Phase III trials, including top-line data for the PIK3CA wild-type patient cohort in Q3 2025. With a strong cash position of $205.7 million, Celcuity is well-equipped to advance its drug development.

Minneapolis, July 2, 2025 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted therapies for oncology, has secured a new U.S. patent for its lead drug candidate, gedatolisib. The patent, U.S. Patent No. 12,350,276, covers the clinical dosing regimen for gedatolisib in ER+/HER2- breast cancer patients, extending Celcuity's market exclusivity in the United States until 2042 [1].

The patent issuance is a significant milestone for Celcuity, which has been actively expanding its intellectual property portfolio. The company's patent portfolio now includes 13 granted patents related to gedatolisib in the U.S. and 290 patents internationally [1]. Brian Sullivan, CEO and Co-Founder of Celcuity, emphasized the importance of this patent in strengthening the company's intellectual property portfolio and optimizing the development of gedatolisib.

Celcuity is currently conducting several clinical trials to evaluate the efficacy of gedatolisib. Topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial is expected in the third quarter of 2025, while data for the PIK3CA mutant cohort is anticipated in the fourth quarter of 2025 [1]. These clinical trials are crucial for assessing the drug's potential in treating ER+/HER2- advanced breast cancer.

With a strong cash position of $205.7 million, Celcuity is well-positioned to advance its drug development efforts. The company's robust patent portfolio and upcoming clinical data readouts are likely to attract investor interest and support the company's growth prospects.

References:
[1] https://www.biospace.com/press-releases/celcuity-announces-issuance-of-new-patent-for-gedatolisib-that-extends-patent-exclusivity-into-2042