Celcuity Inc. (CELC)

Celcuity's stock has experienced significant volatility and substantial increases in the past six months, largely driven by positive clinical trial results and regulatory advancements. In July 2025, the stock surged following positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial, leading to a market capitalization jump. In August 2025, Celcuity announced its Q2 2025 earnings, reporting an EPS miss but secured significant funding and highlighted positive trial results. In September 2025, the FDA agreed to review Celcuity's New Drug Application for gedatolisib under the Real-Time Oncology Review program. In October 2025, Celcuity's stock was up after reporting strong results from a cohort in a Phase 3 trial of gedatolisib and announced major clinical updates for gedatolisib across late-stage breast and prostate cancer trials.

Celcuity, Inc.'s products and services do not exhibit traditional demand seasonality. The demand for its lead drug candidate, gedatolisib, and its CELsignia diagnostic platform is driven by factors such as the prevalence of specific cancer types, the progression of its clinical trials, regulatory approvals, and the adoption of its therapies by medical professionals. Demand is therefore more consistent and tied to ongoing medical needs and scientific advancements rather than cyclical or seasonal patterns.

Celcuity, Inc. is a clinical-stage biotechnology company in the Healthcare sector, focusing on Biotechnology and Medical Research. The company discovers new cancer targets and personalizes cancer treatment, with its lead drug candidate, Gedatolisib, targeting HR+/HER2- advanced or metastatic breast cancer and metastatic castration-resistant prostate cancer. Celcuity also develops the CELsignia multi-omic diagnostic platform to identify cancer-driving signaling pathways and predict patient response to therapies. The company generates revenue through research and development collaborations, companion diagnostic development, and licensing agreements.

Celcuity, Inc. is headquartered in Minneapolis, Minnesota, United States. Its clinical development programs, including the VIKTORIA-1 Phase 3 trial, are conducted in the United States. A planned global trial (VIKTORIA-2) is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia.

Celcuity's brand reputation has been significantly bolstered by positive clinical trial results and regulatory advancements for gedatolisib. The breakthrough efficacy results from the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer have led to an accelerated review by the FDA. The company's commitment to advancing cancer therapies and its innovative CELsignia platform also contribute positively to its reputation. However, Celcuity faces inherent risks that can impact its reputation, including regulatory hurdles, potential delays in clinical trials, intense competition, and the need for continuous funding.

Celcuity Inc. exhibits a mixed ownership structure, including institutional, insider, and retail investors. Institutional shareholders own 74.65% of the company, while Celcuity insiders own 28.02%. Major institutional owners include Baker Bros. Advisors Lp, Bvf Inc/il, Soleus Capital Management, L.P., NEA Management Company, LLC, BlackRock, Inc., Vanguard Group Inc, Perceptive Advisors Llc, Eventide Asset Management, Llc and Saturn V Capital Management LLC. Brian F. Sullivan, Co-Founder, Chairman, and Chief Executive Officer, is a significant individual owner.