Celcuity Inc., a clinical stage biotechnology company, discovers cancer sub-types and therapeutic options for cancer patients in the United States. The company's CELsignia diagnostic platform uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the targeted therapy that treats it. The company is also developing CELsignia MP test, a qualitative laboratory developed test that measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. Celcuity Inc. was founded in 2011 and is headquartered in Minneapolis, Minnesota.
IPO Year: 2017
Exchange: NASDAQ
Website: celcuity.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/1/2025 | $30.00 | Buy | Stifel |
| 7/22/2024 | $29.00 | Outperform | Leerink Partners |
| 2/22/2024 | $40.00 | Buy | Stifel |
| 12/8/2023 | $27.00 | Buy | H.C. Wainwright |
| 10/8/2021 | $50.00 | Buy | Canaccord Genuity |
| 9/7/2021 | $48.00 | Buy | Jefferies |
| 7/29/2021 | Outperform | Cowen | |
| 7/27/2021 | $50.00 | Buy | Needham |
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Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trialHazard ratios and improvements in median progression-free survival ("PFS") are unprecedented in HR+/HER2- advanced breast cancer ("ABC")Expect to submit a New Drug Application ("NDA") for gedatolisib, based on data from the PIK3CA wild-type cohort, to the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2025 Enrollment is ongoing in the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial and topline data readout is anticipated in the fourth quarter of 2025First patient was dosed in Phase 3 VIKTORIA-2 clinical tri
MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call InformationTo participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink:
MINNEAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC) (the "Company"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal amount of its 2.750% convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering"), and its underwritten public offering of 1,836,842 of shares of its common stock (the "Common Stock") at a public offering price of $38.00 per share and, in lieu of Common Stock to investors who so choose, pre-funded warrants to purchase up to 400,000 shares of Common Stock (t
MINNEAPOLIS, July 28, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC) (the "Company"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced proposed underwritten public offerings of $150,000,000 aggregate principal amount of its convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering") and $75,000,000 of shares of its common stock (the "Common Stock" and, such offering, the "Common Stock Offering"). The Company intends to grant the underwriters of the offerings a 30-day option to purchase up to an additional $22,500,000 aggregate principal amount of Convertible Notes, sole
Hazard Ratios and Improvements in Median PFS areUnprecedented in HR+/HER2- Advanced Breast Cancer ("ABC") Gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrantGedatolisib + fulvestrant ("gedatolisib doublet") reduced the risk of progression or death by 67% vs. fulvestrant (HR=0.33; 95% CI: 0.24–0.48; p<0.0001). Median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrantThe efficacy results establish several new milestones in the history of drug developm
MINNEAPOLIS, July 25, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the Company will hold a conference call and webcast on Monday, July 28, 2025 at 8:00 AM ET to disclose the topline results of the PIK3CA Wild-Type Cohort from the Phase 3 VIKTORIA-1 trial. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025 at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleco
MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer ("ABC") who are endocrine therapy resistant. Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR ("PAM") inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway. "We are excited to begin enrolling patie
MINNEAPOLIS, July 14, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the issuance of U.S. Patent No. 12,350,276 covering the clinical dosing regimen for its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients. The patent extends Celcuity's patent exclusivity in the U.S. into 2042. "This dosing regimen patent reflects our commitment to enhancing our intellectual property portfolio," said Brian Sullivan, CEO and Co-Founder of Celcuity. "With patent exclusivity for gedatolisib now extended into 2042, we expect to have a long runway to optimize development o
Equity Insider News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care mo
• In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plusdarolutamide in men with metastatic castration resistant prostate cancer ("mCRPC"),the six-month radiographic progression free survival ("rPFS") rate was 66% • In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer ("mBC"), the objective response rate ("ORR") was 43% • No patients discontinued gedatolisib due to a treatment-related adverse event ("AE") in either clinical trial MINNEAPOLIS, June 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
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Stifel resumed coverage of Celcuity with a rating of Buy and set a new price target of $30.00
Leerink Partners initiated coverage of Celcuity with a rating of Outperform and set a new price target of $29.00
Stifel initiated coverage of Celcuity with a rating of Buy and set a new price target of $40.00
H.C. Wainwright initiated coverage of Celcuity with a rating of Buy and set a new price target of $27.00
Canaccord Genuity initiated coverage of Celcuity with a rating of Buy and set a new price target of $50.00
Jefferies initiated coverage of Celcuity with a rating of Buy and set a new price target of $48.00
Cowen initiated coverage of Celcuity with a rating of Outperform
Needham initiated coverage of Celcuity with a rating of Buy and set a new price target of $50.00
HC Wainwright resumed coverage of Celcuity with a rating of Buy and set a new price target of $19.00 from $18.00 previously
Craig Hallum reiterated coverage of Celcuity with a rating of Buy and set a new price target of $24.00 from $19.00 previously
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MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call InformationTo participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink:
Hazard Ratios and Improvements in Median PFS areUnprecedented in HR+/HER2- Advanced Breast Cancer ("ABC") Gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrantGedatolisib + fulvestrant ("gedatolisib doublet") reduced the risk of progression or death by 67% vs. fulvestrant (HR=0.33; 95% CI: 0.24–0.48; p<0.0001). Median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrantThe efficacy results establish several new milestones in the history of drug developm
MINNEAPOLIS, July 25, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the Company will hold a conference call and webcast on Monday, July 28, 2025 at 8:00 AM ET to disclose the topline results of the PIK3CA Wild-Type Cohort from the Phase 3 VIKTORIA-1 trial. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025 at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleco
The primary completion date of the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is expected in June 2025 and a topline data readout is anticipated in the third quarter of 2025 Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 Phase 3 trial and a topline data readout is anticipated in the fourth quarter of 2025 VIKTORIA-2 Phase 3 trial remains on track to dose its first patient in the second quarter of 2025Initiating a clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancerApproximately $206 million in cash, cash e
MINNEAPOLIS, May 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2025 after the market closes on Wednesday, May 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this
The PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is on track to report topline data in Q2 2025VIKTORIA-2 Phase 3 remains on track to enroll its first patient in Q2 2025Presented encouraging preliminary overall survival data from the Phase 1b study evaluating gedatolisib in combination with palbociclib and endocrine therapy at the 2024 SABCSApproximately $235.1 million in cash, cash equivalents and short-term investments at end of Q4 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, March 31, 2025, at 4:30 p.m. ET MINNEAPOLIS, March 31, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a c
MINNEAPOLIS, March 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2024 after the market closes on Monday, March 31, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed us
The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the third quarter ended September 30, 2024 and other recent business developments.
MINNEAPOLIS, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2024 after the market closes on Thursday, November 14, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call InformationTo participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this webl
Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025Expect to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025Raised $129 million in gross proceeds from equity and debt financings; extending runway of current operational activities through 2026Management to host webcast and conference call today, August 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-sta
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Equity Insider News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care mo
MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer. Mr. Mayer joins Celcuity with over 30 years of biopharmaceutical commercial experience in companies ranging from early-stage biotechs to full scale pharmaceutical companies across many therapeutic areas, including oncology. "Eldon is an exceptional leader with a proven track record of building commercial organizations from the ground up to support the launch of a biotech company's first drug. His significant commercial experience at multiple bio
Seasoned executive brings over two decades of pharmaceutical business development and commercial strategy experience to Celcuity's Board of DirectorsMINNEAPOLIS, MN / ACCESSWIRE / September 14, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced the appointment of Polly Murphy, D.V.M., Ph.D. to its Board of Directors."We are delighted to welcome Dr. Murphy to our Board and look forward to leveraging her business development expertise and broad industry experience as we continue to advance our pipeline," said Brian Sullivan, CEO and Co-Founder of Celcuity.Dr. Murphy joins Cel
MINNEAPOLIS, MN / ACCESSWIRE / November 29, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced the addition of two senior executives to its corporate management team. Michael Snitkovsky joined Celcuity as VP of Program Management and David Bridge joined as VP of Quality Assurance and Process Development."We are pleased to welcome Michael and David to the Celcuity leadership team. Each brings extensive experience across the biopharmaceutical development spectrum, and each has a fantastic track record," said Brian Sullivan, Celcuity's Chief Executive O
MINNEAPOLIS, MN / ACCESSWIRE / June 9, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced the addition of two new senior executives to its clinical drug development and operations team. Igor Gorbatchevsky, MD, joined Celcuity as VP of Clinical Development and Jill Krause joined as VP of Clinical Operations."We are very excited to have Igor and Jill join Celcuity and lead our clinical development and clinical operations teams. Each has very relevant experience at both large pharmaceutical and small biopharma companies," said Celcuity's Chairman and Ch