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October 18, 2025 04:30 ET | Source: Celcuity Inc.

Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial

PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolledAdditional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined...
October 18, 2025 04:30 ET | Source: Celcuity Inc.

Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer (“mCRPC”)

Median radiographic progression free survival (“rPFS”) was 9.1 months and the six-month rPFS rate was 67% No patients discontinued study treatment due to a treatment-related adverse event (“TRAE”) ...
October 18, 2025 04:30 ET | Source: Celcuity Inc.

Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer

Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant...
September 22, 2025 09:15 ET | Source: Celcuity Inc.

Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress

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...
September 09, 2025 16:01 ET | Source: Celcuity Inc.

Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance

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...
August 27, 2025 16:05 ET | Source: Celcuity Inc.

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

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....
August 14, 2025 16:01 ET | Source: Celcuity Inc.

Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trialHazard ratios and improvements in...
August 07, 2025 07:05 ET | Source: Celcuity Inc.

Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call

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...
July 30, 2025 06:30 ET | Source: Celcuity Inc.

Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants

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...
July 28, 2025 16:02 ET | Source: Celcuity Inc.

Celcuity Inc. Announces Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock

MINNEAPOLIS, July 28, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today...