Celcuity Inc. Stock News

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...

MINNEAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal amount of its 2.750% convertible senior notes due 2031 (the “Convertible Notes” and such offering, the “Conv...

Celcuity stock (NASDAQ: CELC), a clinical-stage biotechnology company, experienced an extraordinary 3x surge in a single trading session, with shares rocketing from approximately $14 to a peak of $46 before stabilizing around $37. This dramatic price movement was triggered by positive topline results from the PIK3CA wild-type cohort of the company's Phase 3 VIKTORIA-1 clinical trial for gedatol...