Celcuity reports financial results for the first quarter 2026 and provides a corporate update today. Read our press release here: https://bit.ly/4npRb1G Listen to our webcast conference call today at 4:30 pm ET: https://bit.ly/43ajaZY
About us
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com
- Website
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https://www.celcuity.com
External link for Celcuity
- Industry
- Biotechnology
- Company size
- 51-200 employees
- Headquarters
- Minneapolis, MN
- Type
- Public Company
Locations
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Primary
Get directions
16305 36Th Ave N
Minneapolis, MN 55446, US
Employees at Celcuity
Updates
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This morning, we announced two important updates to our clinical development plan: → We are expanding our Phase 3 VIKTORIA-2 trial to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer. We are now positioned to evaluate nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. This offers the potential to advance the standard-of-care for the approximately 90,000 women each year who are newly diagnosed with late-stage HR+/HER2- ABC. → We are advancing the development of a gedatolisib formulation for subcutaneous injection and have submitted our first patent application to the U.S. Patent and Trademark Office. The subcutaneous formulation is aimed at supporting potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. Read our press release here: https://bit.ly/3P5iWQG
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Celcuity will report on first quarter 2026 financial results next Thursday, May 14, 2026. Celcuity management will host a webcast conference call at 4:30 pm ET. Learn more: https://bit.ly/4uASQUF
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Today, we announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- PIK3CA mutant advanced breast cancer. We look forward to reporting detailed results at the American Society of Clinical Oncology (ASCO) Annual Meeting. Read more here: https://bit.ly/4tKpBP0
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Celcuity reports financial results for the fourth quarter and full year 2025 and provides a corporate update today. Read our press release here: https://bit.ly/4bHFzSk Listen in to our webcast conference call today at 4:30 pm ET: https://bit.ly/4lNVOSu
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Celcuity will report on fourth quarter and full year 2025 financial results next Wednesday, March 25, 2026. Celcuity management will host a webcast conference call at 4:30 pm ET. Learn more: https://bit.ly/4uTNu87
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Yesterday, results from the Phase 3 VIKTORIA-1 clinical trial were published in the Journal of Clinical Oncology. We would like to thank Dr. Sara Hurvitz for serving as a co-primary investigator on this study and for helping us potentially bring this important therapy to patients. Read the manuscript: https://bit.ly/4uCIx3p
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We are proud to announce publication in the Journal of Clinical Oncology of results from the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib in patients with HR+/HER2-/PIK3CA Wild Type Advanced Breast Cancer. We are grateful to all the patients and investigators who participated in the clinical trial. Read more here: https://bit.ly/4ujOzWn #gedatolisib
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Tune in tomorrow to listen to our fireside chat with Celcuity's CEO, Brian Sullivan, and senior biotech analyst, Andrew Berens, MD, MBA, at the Leerink Global Healthcare Conference: https://bit.ly/4c6WAqY
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Tune in tomorrow to listen to our fireside chat with Celcuity CEO, Brian Sullivan, and Tara Bancroft at the TD Securities Cowen 46th Annual Health Care Conference: https://bit.ly/4qOFgKZ
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