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September 01, 2026 08:30 ET | Source: Celcuity Inc.

Celcuity To Participate in Upcoming Investor Conferences

MINNEAPOLIS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid...
August 26, 2026 08:30 ET | Source: Celcuity Inc.

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

If approved, REVTORPYK would be the first and only therapy for advanced breast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 ...
August 13, 2026 16:06 ET | Source: Celcuity Inc.

Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update

REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late...
August 06, 2026 08:34 ET | Source: Celcuity Inc.

Celcuity Schedules Release of Second Quarter 2026 Financial Results and Webcast/Conference Call

MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment...
July 30, 2026 08:30 ET | Source: Celcuity Inc.

Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer

MINNEAPOLIS, July 30, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor...
July 14, 2026 16:53 ET | Source: Celcuity Inc.

Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with...
June 03, 2026 22:13 ET | Source: Celcuity Inc.

Celcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for...
June 03, 2026 07:19 ET | Source: Celcuity Inc.

Celcuity Inc. Announces Public Offering of Convertible Senior Notes Due 2032

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for...
June 02, 2026 08:25 ET | Source: Celcuity Inc.

Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer

Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68;...
June 01, 2026 08:30 ET | Source: Celcuity Inc.

Celcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib Regimens in HR+/HER- Advanced Breast Cancer on June 2, 2026

MINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple...