Celcuity Inc. (CELC)
| Market Cap | 5.80B |
| Revenue (ttm) | n/a |
| Net Income (ttm) | -177.04M |
| Shares Out | 48.34M |
| EPS (ttm) | -3.79 |
| PE Ratio | n/a |
| Forward PE | n/a |
| Dividend | n/a |
| Ex-Dividend Date | n/a |
| Volume | 708,901 |
| Open | 125.68 |
| Previous Close | 125.68 |
| Day's Range | 119.71 - 127.04 |
| 52-Week Range | 9.51 - 129.09 |
| Beta | 0.42 |
| Analysts | Strong Buy |
| Price Target | 112.56 (-6.25%) |
| Earnings Date | May 13, 2026 |
About CELC
Celcuity Inc., a clinical-stage biotechnology company, focuses on the development of targeted therapies for the treatment of various solid tumors in the United States. The company’s lead drug candidate includes Gedatolisib, which selectively targets various Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and the two mechanistic targets of rapamycin (mTOR) sub-complexes, mTORC1 and mTORC2 to treat patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) or HR+/HER2-, advanced or metastatic... [Read more]
Financial Performance
Financial StatementsAnalyst Forecast
According to 9 analysts, the average rating for CELC stock is "Strong Buy." The 12-month stock price target is $112.56, which is a decrease of -6.25% from the latest price.
News
Celcuity Earnings Call Transcript: Q4 2025
Achieved key milestones in 2025, including FDA priority review for gedatolisib and strong pivotal trial results. Net loss increased due to R&D and commercial investments, but cash reserves are expected to fund operations through 2027. Positive market feedback and a large addressable market support a strong outlook.
Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
MINNEAPOLIS, March 25, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial ...
Celcuity Schedules Release of Fourth Quarter and Full Year 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, March 18, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it wi...
Celcuity Transcript: Leerink Global Healthcare Conference 2026
Gedatolisib has shown unprecedented efficacy in second-line breast cancer, with strong early results in both wild-type and mutant populations. Commercial launch preparations are nearly complete, with a mid-July approval targeted, and international expansion is planned following key data readouts.
Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology
MINNEAPOLIS, March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced publicatio...
Celcuity Transcript: TD Cowen 46th Annual Health Care Conference
Three clinical trials are advancing for Gedatolisib, with key mutant data expected soon and strong confidence in regulatory timelines. Launch preparations are on track, targeting a large breast cancer market with a favorable safety profile and significant peak revenue potential.
Celcuity To Participate in Upcoming Investor Conferences
MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian ...
Celcuity Appoints Charles Romp to its Board of Directors
MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appoint...
Celcuity Transcript: Guggenheim Securities Emerging Outlook: Biotech Summit 2026
Positive phase 3 data and NDA acceptance set the stage for a potential mid-2024 launch of gedatolisib, with robust commercial infrastructure nearly complete. The drug demonstrates unprecedented efficacy and tolerability, targeting a multi-billion dollar U.S. market opportunity.
Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026
MINNEAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its partici...
Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing d...
Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium
MINNEAPOLIS, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated res...
Celcuity Transcript: Evercore ISI 8th Annual HealthCONx Conference
Gedatolisib, a pan-PI3K/mTOR inhibitor, is advancing through multiple phase III trials in HR-positive, HER2-negative breast cancer, showing strong efficacy and a favorable safety profile. The company is preparing for commercial launch, targeting a $6 billion market.
Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium
MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abs...
Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference
MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its partici...
Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the complet...
Celcuity Earnings Call Transcript: Q3 2025
Major clinical and regulatory milestones were achieved, including positive phase III data for Gedatolisib and FDA acceptance for NDA submission. Financially, net loss widened year-over-year, but the balance sheet was strengthened with $455 million in cash and expanded debt capacity. Commercial launch preparations are advanced, with peak revenue potential estimated at $2.5–$3 billion.
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Presented detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial at a late breaking oral presentation at the 2025 European Society for Me...
Celcuity Transcript: Stifel 2025 Healthcare Conference
Transformational progress includes strong clinical data for gedatolisib in breast and prostate cancer, robust regulatory and commercial preparations, and positive market feedback. Financial runway extends through 2027, with global regulatory strategies advancing.
Celcuity Inc. Schedules Release of Third Quarter 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it wil...
Celcuity To Present at Upcoming Stifel 2025 Healthcare Conference
MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its partici...
CRMD, RANI, CELC, RAPT: four biotech stocks flying high today and why
Biotech stocks are lighting up the tape today, with several clinical-stage companies posting double-digit gains on fresh catalysts. From earnings beats to promising trial data and billion-dollar partn...
Celcuity Transcript: Study Result
The VIKTORIA-1 phase III trial showed that gedatolisib, as a triplet or doublet regimen, significantly improved progression-free survival and response rates in HR positive, HER2 negative advanced breast cancer patients with PIK3CA wild type disease, with a favorable safety profile and low discontinuation rates. NDA submission is expected this quarter.
Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer
MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed ef...