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Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast cancer (“ABC”). The NDA was submitted under the FDA’s Real-Tim Nov 17, 2025 - $CELC
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Presented detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial at a late breaking oral presentation at the 2025 European Society for Medical Oncology (“ESMO”) Congress Presented updated clinical results from the Phase 1b portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) in men with metastatic castration resistant prostate cancer (“mCRPC”) at a poster session at ESMO Completed enrollment o Nov 12, 2025 - $CELC
Assessing Celcuity (CELC): What a 71x Price-to-Book Ratio Says About Valuation
Celcuity (CELC) shares are turning heads as investors take notice of its recent stock movement over the past month, during which it climbed more than 61%. That kind of momentum always invites fresh scrutiny as investors consider what might be driving interest. See our latest analysis for Celcuity. Celcuity’s recent surge caps off what has been an extraordinary year for the stock, with its share price up an eye-popping 467.56% year-to-date and a 1-year total shareholder return of 370.16%. This... Nov 10, 2025 - $CELC
Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To p Nov 5, 2025 - $CELC
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference
MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Stifel 2025 Healthcare Conference to be held in New York on November 11-13, 2025. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 10:00 a.m. ET on Tuesday, November 11, 2025. A live webcast of the event will be available using th Nov 4, 2025 - $CELC
Insider-Favored Growth Stocks To Consider In October 2025
As of late October 2025, major U.S. stock indexes have reached new record highs, buoyed by solid corporate earnings and optimism surrounding potential trade agreements between the U.S. and China. Amidst these favorable market conditions, growth companies with high insider ownership can present intriguing opportunities for investors seeking alignment between company executives' interests and shareholder value. Oct 29, 2025 - $CELC
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