| Symbol | CELC |
|---|---|
| Name | CELCUITY INC. |
| Sector | HEALTH CARE |
| Region | North America |
| Industry | Medical Specialities |
| Address | 16305 36TH AVENUE NORTH,SUITE 100, MINNEAPOLIS, Minnesota, 55446, United States |
| Telephone | +1 -763 392-0767 |
| Fax | — |
| — | |
| Website | https://www.celcuity.com |
| Incorporation | UNDEFINED |
| Incorporated On | — |
| Employees | — |
| Fiscal Year | — |
| Public Since | — |
| Exchanges | NASDAQ |
| Auditor | — |
| Audit Status | NOT PROVIDED |
| Reporting Status | — |
| CIK | 0001603454 |
| Description | Celcuity Inc is clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic (Rx) and companion diagnostic (CDx) strategy. The companys drug candidate, gedatolisib, is a potent, well-tolerated, small molecule dual inhibitor, administered intravenously, that selectively targets all class I isoforms of PI3K and mammalian target of rapamycin (mTOR). Additional info from NASDAQ: |
(19% Negative) CELCUITY INC. (CELC) Announces Delay in patients Trials for multiple solid tumor indications Due to Regulatory Process, Safety Review, Efficacy Assessment
Read moreCelcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
Read moreLaing Lance G. 🟢 acquired 30.0K shares (1 derivative) of Celcuity Inc. (CELC) Transaction Date: Aug 14, 2026 | Filing ID: 000004
Read moreSullivan Brian F. 🟢 acquired 200.0K shares (1 derivative) of Celcuity Inc. (CELC) Transaction Date: Aug 14, 2026 | Filing ID: 000002
Read moreHahne Vicky 🟢 acquired 26.0K shares (1 derivative) of Celcuity Inc. (CELC) Transaction Date: Aug 14, 2026 | Filing ID: 000002
Read moreNew Form SCHEDULE 13G - Celcuity Inc. <b>Filed:</b> 2026-08-11 <b>AccNo:</b> 0000070858-26-000425 <b>Size:</b> 171 KB
Read moreINVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Celcuity Inc. - CELC
Read moreCelcuity Schedules Release of Second Quarter 2026 Financial Results and Webcast/Conference Call
Read moreCELC SHAREHOLDER ALERT: Celcuity Inc. Investors Encouraged to Contact Kirby McInerney LLP About Potential Securities Laws Violations
Read more| Trial ID | Title | Phase | Indication | Status | Start Date | Completion Date | Source |
|---|---|---|---|---|---|---|---|
| NCT05134922 | Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2… | — | Breast Neoplasm Malignant Female | Available | — | — | ClinicalTrials.gov |
| NCT06757634 | Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Posit… | Phase3 | Breast Cancer | Recruiting | 2025-07-24 | 2033-07-30 | ClinicalTrials.gov |
| NCT06190899 | Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant… | Phase1 | mCRPC (Metastatic Castration-resistant Prostate Cancer) | Recruiting | 2024-01-01 | 2030-01-01 | ClinicalTrials.gov |
| NCT04901299 | Fulvestrant + Neratinib In Breast Cancer | Phase2 | Stage IV (Metastatic) Breast Cancer | Withdrawn | 2023-07-01 | 2025-07-01 | ClinicalTrials.gov |
| NCT05501886 | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care fo… | Phase3 | Breast Cancer | Active_Not_Recruiting | 2022-12-08 | 2026-12-31 | ClinicalTrials.gov |
| NCT05243641 | Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer … | Phase1 | Metastatic Breast Cancer | Terminated | 2022-08-18 | 2024-11-19 | ClinicalTrials.gov |
| NCT03812393 | Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction A… | Phase2 | Triple Negative Breast Cancer | Unknown | 2019-06-21 | 2024-12-15 | ClinicalTrials.gov |
| NCT03911973 | Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, H… | Phase1 | TNBC - Triple-Negative Breast Cancer | Active_Not_Recruiting | 2019-04-17 | 2024-07-01 | ClinicalTrials.gov |
| NCT02684032 | A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Comb… | Phase1 | Breast Cancer | Completed | 2016-06-14 | 2022-01-19 | ClinicalTrials.gov |
| Product Name | Type | Development Stage | Therapeutic Area | Study Status | Trial ID |
|---|---|---|---|---|---|
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm D: Ribociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm C: Gedatolisib + Palbociclib + Letrozole | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm B: Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Fulvestrant | Other | Phase PHASE1 | Breast Cancer | COMPLETED | NCT02684032 |
| Letrozole | Other | Phase PHASE1 | Breast Cancer | COMPLETED | NCT02684032 |
| Palbociclib | Other | Phase PHASE1 | Breast Cancer | COMPLETED | NCT02684032 |
| Gedatolisib | Other | Phase PHASE1 | Breast Cancer | COMPLETED | NCT02684032 |
| FULVESTRANT | Other | Phase PHASE2 | Stage IV (Metastatic) Breast Cancer | WITHDRAWN | NCT04901299 |
| NERATINIB | Other | Phase PHASE2 | Stage IV (Metastatic) Breast Cancer | WITHDRAWN | NCT04901299 |
| Neratinib | Other | Phase PHASE2 | Triple Negative Breast Cancer | UNKNOWN | NCT03812393 |
| Talazoparib | Other | Phase PHASE1 | TNBC - Triple-Negative Breast Cancer | ACTIVE_NOT_RECRUITING | NCT03911973 |
| Gedatolisib | Other | Phase PHASE1 | TNBC - Triple-Negative Breast Cancer | ACTIVE_NOT_RECRUITING | NCT03911973 |
| Gedatolisib | Other | Preclinical | Breast Neoplasm Malignant Female | AVAILABLE | NCT05134922 |
| Capmatinib | Other | Phase PHASE1 | Metastatic Breast Cancer | TERMINATED | NCT05243641 |
| Neratinib | Other | Phase PHASE1 | Metastatic Breast Cancer | TERMINATED | NCT05243641 |
| Alpelisib | Other | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Fulvestrant | Other | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Palbociclib | Other | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Gedatolisib | Other | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Arm B: Palbociclib or Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant | Other | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Darolutamide | Other | Phase PHASE1 | mCRPC (Metastatic Castration-resistant Prostate Cancer) | RECRUITING | NCT06190899 |
| Gedatolisib | Other | Phase PHASE1 | mCRPC (Metastatic Castration-resistant Prostate Cancer) | RECRUITING | NCT06190899 |
| Arm B: Palbociclib or Ribociclib + Fulvestrant | DRUG | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant | DRUG | Phase PHASE3 | Breast Cancer | RECRUITING | NCT06757634 |
| Darolutamide | DRUG | Phase PHASE1 | mCRPC (Metastatic Castration-resistant Prostate Cancer) | RECRUITING | NCT06190899 |
| Alpelisib | DRUG | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Capmatinib | DRUG | Phase PHASE1 | Metastatic Breast Cancer | TERMINATED | NCT05243641 |
| FULVESTRANT | DRUG | Phase PHASE2 | Stage IV (Metastatic) Breast Cancer | WITHDRAWN | NCT04901299 |
| NERATINIB | DRUG | Phase PHASE2 | Stage IV (Metastatic) Breast Cancer | WITHDRAWN | NCT04901299 |
| Talazoparib | DRUG | Phase PHASE1 | TNBC - Triple-Negative Breast Cancer | ACTIVE_NOT_RECRUITING | NCT03911973 |
| Neratinib | DRUG | Phase PHASE1 | Metastatic Breast Cancer | TERMINATED | NCT05243641 |
| Fulvestrant | DRUG | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Letrozole | DRUG | Phase PHASE1 | Breast Cancer | COMPLETED | NCT02684032 |
| Palbociclib | DRUG | Phase PHASE3 | Breast Cancer | ACTIVE_NOT_RECRUITING | NCT05501886 |
| Gedatolisib | DRUG | Phase PHASE1 | mCRPC (Metastatic Castration-resistant Prostate Cancer) | RECRUITING | NCT06190899 |