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Celcuity

CELC

Market cap $3.22B

65.80 USD

+0.55

0.84%

At close Updated Oct 26, 4:00 PM EDT

Pre-market

After hours

65.80

0.00

0%

1 day

0.84%

5 days

15.2%

1 month

-17.38%

3 months

-20.02%

6 months

-47.64%

Year to date

-34.56%

1 year

-15.11%

5 years

269.46%

10 years

360.46%

About: Celcuity Inc is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumors. Its candidate, gedatolisib, is a kinase inhibitor of the PI3K/AKT/mTOR (PAM) pathway, binding all class I PI3K isoforms and mTORC1/2, offering comprehensive inhibition with a mechanism and pharmacokinetics differentiated from other therapies. The Phase 3 VIKTORIA-1 trial, evaluating gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2- breast cancer, has completed enrollment and reported results for PIK3CA WT tumors, with cohort 2 (PIK3CA MT) also enrolled. Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials, evaluating combinations in endocrine-resistant HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer, are ongoing.

Employees: 155

Healthcare Biotechnology

News

Positive

Neutral

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Sentiment 3-Months

Positive 11.1%

Neutral 81.5%

Negative 7.4%

Celcuity Presents Updated Results from the PIK3CA MT Cohort of the Phase 3 VIKTORIA-1 Study in Patients with HR+/HER2- Advanced Breast Cancer at the ESMO Congress 2026

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases

Celcuity Presents Updated Results from the PIK3CA MT Cohort of the Phase 3 VIKTORIA-1 Study in Patients with HR+/HER2- Advanced Breast Cancer at the ESMO Congress 2026

Celcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026

Median radiographic progression free survival (“rPFS”) was 15.7 months and the six-month rPFS rate (“rPFS6”) was 82.2% in patients who received prior abiraterone

Celcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026

Zacks Investment Research

New Strong Sell Stocks for October 14th

ADDYY, CELC and CNL have been added to the Zacks Rank #5 (Strong Sell) List on October 14, 2026.

New Strong Sell Stocks for October 14th

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 breast cancer Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC MINNEAPOLIS, Oct. 05, 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 a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented.

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Celcuity Appoints David Gryska To Its Board Of Directors

Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity's Board Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity's Board

Celcuity Appoints David Gryska To Its Board Of Directors

The Motley Fool

Why Celcuity Stock Was a Winner on Wednesday

This is a breast cancer treatment, Revtorpyk. It was approved by the FDA in July.

Why Celcuity Stock Was a Winner on Wednesday

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 isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathway In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant Healthcare providers can visit www.revtorpykhcp.com to access a comprehensive patient support program through REVTORPYK Support Services MINNEAPOLIS, Sept. 30, 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 REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

Celcuity Inc. (CELC) Presents at Citigroup's Biopharma Back to School Summit 2026 Prepared Remarks Transcript

Celcuity Inc. (CELC) Presents at Citigroup's Biopharma Back to School Summit 2026 Prepared Remarks Transcript

Celcuity Inc. (CELC) Presents at Citigroup's Biopharma Back to School Summit 2026 Prepared Remarks Transcript

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 Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

Celcuity To Participate in Upcoming Investor Conferences

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

MINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced the submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy.

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

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