Celcuity Prepares for Key Phase 3 Trial Results on Gedatolisib
By ATTN Desk · Editorial oversight: Sean Han
Introduction
Celcuity Inc (NASDAQ: CELC) is a clinical-stage biotechnology company founded in 2012 and based in Minneapolis, Minnesota. The firm applies proprietary insights into oncogenic pathways to develop targeted cancer therapies. Its lead candidate, gedatolisib, is an intravenously administered pan-PI3K and mTORC1/2 inhibitor designed to block the PI3K/AKT/mTOR (PAM) pathway.
Corporate Structure and Team
Celcuity employs between 51 and 200 people, including specialists in drug discovery, cell signaling, high-throughput screening, and clinical development. The executive leadership has experience across the biotech and biopharmaceutical sectors:
- A founder-CEO with a history of building and exiting medical device and technology companies
- Drug discovery experts with NIH fellowships and over 20 years in molecular oncology
- Finance and commercial executives with experience in guiding healthcare firms through IPOs, mergers and acquisitions, and product launches
Cancer therapy by National Cancer Institute
Recent Developments and News
On July 28, 2025, at 8:00 a.m. ET, Celcuity will host an investor call to discuss topline results from its Phase 3 VIKTORIA-1 trial. This study evaluates gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer. Earlier in 2025, the company reported improvement in progression-free survival primary endpoints from the PIK3CA wild-type cohort of VIKTORIA-1.
In parallel, the first patient has been dosed in VIKTORIA-2, a Phase 3 trial assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line therapy for HR+/HER2- advanced breast cancer. The Phase 1b/2 CELC-G-201 trial in metastatic castration-resistant prostate cancer, which includes gedatolisib combined with darolutamide, is ongoing.
Financial and Strategic Analysis
| Metric | Value |
|---|---|
| Share Price | $48.10 |
| Price Change | +249.31% |
| Trading Volume | 2,559,032 |
| Exchange | NASDAQ (CELC) |
| Employees | 51–200 |
| Headquarters | Minneapolis, MN |
As of the beginning of 2025, Celcuity’s share price increased by approximately 249%. As a clinical-stage company, Celcuity does not generate product revenue, and its valuation is largely influenced by clinical milestones and partnerships. Gedatolisib’s dual mechanism—blocking both PI3K and mTORC1/2—may position the company for potential collaborations or licensing agreements contingent on clinical results.
Market Position and Industry Context
The PI3K/AKT/mTOR pathway is involved in multiple solid tumors, including breast, prostate, endometrial, ovarian, and hematological cancers. Competition includes selective PI3Kα inhibitors, AKT inhibitors, and mTORC1-specific agents. By targeting both PI3K and mTORC1/2, Celcuity aims to address resistance issues associated with mono-target therapies. The company’s clinical programs focus on HR+/HER2- advanced breast cancer and castration-resistant prostate cancer. Successful outcomes in these sectors could establish gedatolisib as an option in the oncology market.
tl;dr
On July 28, 2025, Celcuity will present topline Phase 3 VIKTORIA-1 results in HR+/HER2- advanced breast cancer. The first patient has been dosed in the VIKTORIA-2 trial, and the Phase 1b/2 prostate cancer study is ongoing. Shares trade at $48.10, reflecting a 249% year-to-date increase, with market focus on clinical results and potential collaborations for its pan-PI3K/mTOR inhibitor gedatolisib.