CELC · Celcuity Inc. · Investor Relations
Press releases and events scraped from the company’s investor relations website. Past events open our own call or event page when we host one; otherwise listings link to the original source.
Recent news
| Date | Headline |
|---|---|
| 2026-10-05 |
Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026
Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced |
| 2026-10-02 |
Celcuity Appoints David Gryska To Its Board Of Directors
Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity’s Board MINNEAPOLIS, Oct. 02, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor |
| 2026-09-30 |
Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States
REVTORPYK is indicated for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K |
| 2026-09-01 |
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 tumor indications, today announced that Brian Sullivan, Chief Executive Officer and Co-founder of |
| 2026-08-26 |
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 MINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. |
| 2026-08-13 |
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 third quarter 2026 NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with |
| 2026-08-06 |
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 of multiple solid tumor indications, today announced that it will release its financial results for |
| 2026-07-30 |
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
REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, listed as a preferred Category 1 regimen for second-line or subsequent treatment for tumors without a PIK3CA mutation following progression on or after at least one line of endocrine therapy MINNEAPOLIS, July 30, |
| 2026-07-14 |
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 mTORC2 In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant and REVTORPYK combined with fulvestrant reduced the risk of disease |
| 2026-06-04 |
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 the treatment of multiple solid tumor indications, today announced the pricing of its upsized |
| 2026-06-03 |
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 the treatment of multiple solid tumor indications, today announced a proposed underwritten public |
| 2026-06-02 |
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; p |
Past events
| Date | Event | Type |
|---|---|---|
| 2026-09-09 | Citi's 2026 Biopharma Back to School Summit | Conference |
| 2026-09-08 | Wells Fargo 21st Annual Healthcare Conference | Conference |
| 2026-08-13 | Q2 FY2026 Earnings conference call (announced in 8-K) | Earnings call |
| 2026-07-14 | Earnings conference call (announced in 8-K) | Earnings call |
| 2026-07-14 | REVTORPYK FDA Approval Conference Call | Conference |
| 2026-06-10 | Goldman Sachs 47th Annual Global Healthcare Conference 2026 | Conference |
| 2026-06-04 | Jefferies Global Healthcare Conference | Conference |
| 2026-06-02 | Phase 3 VIKTORIA-1 PIK3CA Mutant Cohort Clinical Trial Results Conference Call | Earnings call |
| 2026-05-14 | First Quarter 2026 Financial Results and Webcast/Conference Call | Earnings call |
| 2026-03-25 | Fourth Quarter 2025 Financial Results and Webcast/Conference Call | Earnings call |
| 2025-10-20 | Phase 3 VIKTORIA-1 HR+/HER2-/PIK3CA WT Trial Results Presentation | Presentation |
Source: https://ir.celcuity.com/