Celcuity Inc. (CELC)

Celcuity Inc. (CELC) is a clinical-stage biotechnology innovator that is redefining "Precision Medicine" through the development of targeted therapies for solid tumors. Led by CEO and Co-Founder Brian Sullivan, Celcuity’s mission is to "Extend the lives of cancer patients by discovering and developing more effective targeted therapies." The company holds a strategic industry position with its proprietary "CELsignia" platform, which analyzes live patient tumor cells to identify the specific cellular drivers of cancer. By late 2025, the CELC stock has been one of the biotech sector’s top performers, following transformative Phase III data for its lead candidate, gedatolisib, which showed a dramatic improvement in progression-free survival for breast cancer patients. Its vision is to become the leader in "Pan-Pathway Oncology" treatments.

The business operations of Celcuity revolve around the clinical development of gedatolisib, a first-in-class pan-PI3K/mTOR inhibitor. The core growth driver in 2025 was the "VIKTORIA-1 Phase III Breakthrough," where the triple-combination therapy reduced the risk of disease progression by 76% in patients with HR+/HER2- advanced breast cancer. Following this success, the company submitted its New Drug Application (NDA) to the FDA in late 2025, positioning itself for a major commercial launch in 2026. The 2026 strategic roadmap focuses on "The Commercial Readiness Pivot," aiming to build a specialized oncology sales force while expanding clinical trials into other high-need areas like prostate and ovarian cancer. By utilizing its "Diagnostic-First Moat"—where it uses its CELsignia platform to identify the 30% of patients who would benefit most from its drugs—Celcuity achieves a higher clinical success rate than traditional pharma models. This "Precision Efficiency" is a primary driver for the CELC stock price, as the company moves toward becoming a multi-billion-dollar commercial-stage biopharma entity.

The CELC stock is listed on the NASDAQ Global Market under the ticker symbol CELC. As a "High-Alpha" biotech play, Celcuity Inc. has seen its market capitalization surge as it transitions from a research firm to a commercial power. For investors monitoring the CELC stock price, the upcoming FDA PDUFA date for gedatolisib and the release of mutation-cohort data are the most significant near-term catalysts. The Celcuity stock represents a high-conviction bet on the next generation of breast cancer standards-of-care.