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January 20, 2026 07:30 ET | Source: Celcuity Inc.

Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company...
December 11, 2025 14:35 ET | Source: Celcuity Inc.

Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib...
November 26, 2025 16:05 ET | Source: Celcuity Inc.

Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an...
November 26, 2025 07:05 ET | Source: Celcuity Inc.

Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference

MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its...
November 17, 2025 16:05 ET | Source: Celcuity Inc.

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...
November 12, 2025 16:01 ET | Source: Celcuity Inc.

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...
November 05, 2025 07:05 ET | Source: Celcuity Inc.

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...
November 04, 2025 07:05 ET | Source: Celcuity Inc.

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...
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.

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...