Celcuity Inc. Stock News

MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being ...

MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and Oxford Finance LLC, and its affiliates (together, “Ox...

Celcuity Shares Surge to Record High on Accelerated FDA Review

MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and Drug Administration (“FDA”) agreed to accept its New Drug Application (“NDA”) for gedatolisib in HR+/HER2- advanced breast cancer (“ABC”) for review under the Real-Time Oncology Review (“RTO...

Celcuity Inc. (NASDAQ:CELC ) Q2 2025 Earnings Conference Call August 14, 2025 4:30 PM ET Company Participants Brian F. Sullivan - Co-Founder, Chairman & CEO Vicky Hahne - Chief Financial Officer Conference Call Participants Chase Richard Knickerbocker - Craig-Hallum Capital Group LLC, Research Division Eason Lee - Leerink Partners LLC, Research Division Frances Dovell - TD Cowen, Research Divis...

MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the second quarter ended June 30, 2025 and other recent business developments.

MINNEAPOLIS, Aug. 07, 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 second quarter 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Tim...

Celcuity's phase 3 VIKTORIA-1 trial showed gedatolisib significantly improved progression-free survival in PIK3CA wild-type HR+/HER2- advanced breast cancer patients. NDA submission for gedatolisib in 2nd-line PIK3CA wild-type HR+/HER2- ABC patients is planned for Q4 2025, with expansion to mutant and 1st-line cohorts underway as well. Strong market opportunity exists as HR+/HER2- breast cancer...