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Stock impact report

Celcuity Highlights Gedatolisib Breast Cancer Data, Near-Term Mutant Readout at Leerink Conference [Yahoo! Finance]

Celcuity Inc. (CELC) 
Last celcuity inc. earnings: 3/12 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: celcuity.com/home/investors
Company Research Source: Yahoo! Finance
breast cancer — the triplet (gedatolisib + palbociclib + fulvestrant) showed median PFS of 9.3 vs 2 months with a hazard ratio of 0.24, supporting the company's thesis that comprehensive PI3K/mTOR inhibition can benefit patients regardless of PIK3CA status. The company expects a near-term readout from the PIK3CA-mutant cohort "end of this quarter, sometime next quarter," citing early phase Ib signals of ~14.5–19 months median PFS and noting that ~10 months would be statistically meaningful versus prior controls (alpelisib + fulvestrant) and compares favorably with other regimens. Celcuity is preparing for commercialization and regulatory milestones — targeting a mid-July PDUFA date, hiring a sales force beginning in Q2, viewing IV administration as commercially acceptable, and pausing ex-U.S. partnering talks pending the mutant-cohort data. Interested in Celcuity, Inc.? Here are five stocks we like better. 3 Stocks You'll Wish You Bought Before 2026 Celcuity (NASDAQ:CELC) Ch Show less Read more
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