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 |
|---|---|---|---|
| 11/18/2025 | $110.00 | Outperform | Wolfe Research |
| 11/17/2025 | Buy → Neutral | H.C. Wainwright | |
| 9/22/2025 | $110.00 | Buy | Guggenheim |
| 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 |
144 - Celcuity Inc. (0001603454) (Subject)
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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
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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 abstract was accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) and is now available on the SABCS website. The 2025 SABCS is being held virtually and in-person from December 9-12, 2025. The presentation will include additional sub-group efficacy analyses and safety data. Abstract presentation details are provided below. Abstract Title: Gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant with or without palbociclib for second-line (2L
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 participation in the 8th Annual Evercore Healthcare Conference to be held in Miami, Florida on December 2-4, 2025. Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, is scheduled for a fireside chat at 7:30 a.m. ET on Wednesday, December 3, 2025. A live webcast of the event will be available using this weblink https://wsw.com/webcast/evercore52/celc/2320846. Alternatively, the live webcast will be accessible from the Investors section of the company's website at https://ir.celcuity.c
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 completion of the submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), advanced breast cancer ("ABC"). The NDA was submitted under the FDA's Real-Time Oncology Review ("RTOR") program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on p
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 Medical Oncology ("ESMO") Congress Presented updated clinical results from the Phase 1b portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) in men with metastatic castration resistant prostate cancer ("mCRPC") at a poster session at ESMO Completed enrollment of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial and expect topline data to be available sometime in late Q1 2026 or during Q2 2026 Submission of a New Drug Application ("NDA") t
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 will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 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 webli
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 participation in the Stifel 2025 Healthcare Conference to be held in New York on November 11-13, 2025. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 10:00 a.m. ET on Tuesday, November 11, 2025. A live webcast of the event will be available using this weblink https://event.summitcast.com/view/cwkmPXkC4dosg6MoG95rxb/TdhPBfiMCSQpwPu5E5FzDS. Alternatively, the live webcast will be accessible from the Investors section of the company's website at
Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and in 11.5% of patients treated with gedatolisib + fulvestrant ("gedatolisib doublet")Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doubletManagement to host webcast and conference call October 20, 2025, at 8:00 a.m. ET MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing
Median radiographic progression free survival ("rPFS") was 9.1 months and the six-month rPFS rate was 67% No patients discontinued study treatment due to a treatment-related adverse event ("TRAE") MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated clinical results from the Phase 1 portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide), an androgen receptor inhibitor, in men with mCRPC whose disease had progressed on prior treatment with a next generation androgen receptor inhibitor. These data were presented
PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolledAdditional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival ("PFS") of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer ("ABC") MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and w
MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial. Late Breaking Oral Presentation Details: Title: Gedatolisib + fulvestrant ± palbociclib vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advan
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Wolfe Research initiated coverage of Celcuity with a rating of Outperform and set a new price target of $110.00
H.C. Wainwright downgraded Celcuity from Buy to Neutral
Guggenheim initiated coverage of Celcuity with a rating of Buy and set a new price target of $110.00
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
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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 will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 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 webli
Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and in 11.5% of patients treated with gedatolisib + fulvestrant ("gedatolisib doublet")Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doubletManagement to host webcast and conference call October 20, 2025, at 8:00 a.m. ET MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing
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.