SymbolCELC
NameCELCUITY INC.
SectorHEALTH CARE
RegionNorth America
IndustryMedical Specialities
Address16305 36TH AVENUE NORTH,SUITE 100, MINNEAPOLIS, Minnesota, 55446, United States
Telephone+1 -763 392-0767
Fax
Email
Websitehttps://www.celcuity.com
IncorporationUNDEFINED
Incorporated On
Employees
Fiscal Year
Public Since
ExchangesNASDAQ
Auditor
Audit StatusNOT PROVIDED
Reporting Status
CIK
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:
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).

2026-05-01 21:10

(19% Negative) CELCUITY INC. (CELC) Announces Delay in palbociclib Trials for oncology Due to Regulatory Process, Safety Review, Efficacy Assessment

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2026-05-01 21:03

Celcuitys Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort

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2026-04-13 20:02

NIGON RICHARD 🔴 sold 10.0K shares of Celcuity Inc. (CELC) Transaction Date: Apr 09, 2026 | Filing ID: 000005

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2026-04-02 20:05

Buller Richard E 🟡 adjusted position in 3.0K shares (1 derivative) of Celcuity Inc. (CELC) at $110.83 Transaction Date: Mar 31, 2026 | Filing ID: 000002

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2026-04-02 17:35

New Form DEFA14A - Celcuity Inc. <b>Filed:</b> 2026-04-02 <b>AccNo:</b> 0001493152-26-014941 <b>Size:</b> 912 KB

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2026-04-02 17:31

New Form DEF 14A - Celcuity Inc. <b>Filed:</b> 2026-04-02 <b>AccNo:</b> 0001493152-26-014937 <b>Size:</b> 2 MB

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2026-03-31 20:38

📋 Buller Richard E (Director) plans to sell 6K shares of Celcuity Inc. (at $110.27 each, total $662K) Filed: Mar 31, 2026 | ID: 000121

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2026-03-26 08:31

New Form 10-K - Celcuity Inc. <b>Filed:</b> 2026-03-26 <b>AccNo:</b> 0001493152-26-012801 <b>Size:</b> 8 MB

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2026-03-25 20:10

(30% Negative) CELCUITY INC. (CELC) Reports Q1 2026 Financial Results

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2026-03-25 20:01

Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

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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 2028-12-30 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
Total clinical trials: 9
Product Name Type Development Stage Therapeutic Area Study Status Trial ID
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
Total products: 33