Core Insights - Celcuity Inc. has been granted U.S. Patent No. 12,350,276 for the clinical dosing regimen of its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients, extending patent exclusivity until 2042 [1][2] - The company has a robust patent portfolio for gedatolisib, including 13 granted patents in the U.S. and 290 patents in foreign jurisdictions [2] - Celcuity plans to announce topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in Q3 2025 and for the PIK3CA mutant cohort in Q4 2025 [3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway, differentiating it from other therapies [4] - The company is currently conducting multiple clinical trials, including the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer and the Phase 1/2 CELC-G-201 trial for metastatic castration-resistant prostate cancer [4]

Core Insights - Evoke Pharma, Inc. has received a Notice of Allowance from the USPTO for a patent application related to GIMOTI® nasal spray, extending patent exclusivity by an additional 6 years, expected to expire in December 2036 [1][2] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly through its product GIMOTI®, a nasal spray formulation of metoclopramide [6] - GIMOTI® is the only FDA-approved non-oral, self-administered formulation of metoclopramide, indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [5][7] Product Significance - The new patent allowance enhances the GIMOTI® franchise by providing additional protection for its use in patients with moderate to severe symptoms of gastroparesis, a condition that complicates the absorption of oral medications [2][3] - GIMOTI® addresses a significant need in the market as gastroparesis affects millions globally, leading to serious gastrointestinal symptoms and complications [7] Market Commitment - The company is committed to supporting the gastroparesis community and will participate in Gastroparesis Awareness Month to improve treatment options and disease awareness [4]