Celcuity Inc.: insider trades · United States · SEC (Form 4)

About Celcuity Inc.

Celcuity Inc. is a U.S.-based clinical-stage biotechnology company listed on the Nasdaq market in the United States. Headquartered in Minneapolis, Minnesota, the company focuses on precision oncology and the development of targeted therapies for multiple solid tumor indications. For investors, Celcuity fits the profile of a development-stage biopharma company: it is still in the value-creation phase, with the investment case driven primarily by clinical data, regulatory milestones, and eventual commercialization prospects rather than by a broad legacy product portfolio. The company’s core asset is gedatolisib, its lead therapeutic candidate. Gedatolisib is described by Celcuity as a potent pan-PI3K and mTORC1/2 inhibitor that broadly blocks the PI3K/AKT/mTOR pathway, a key signaling network implicated in tumor growth and resistance mechanisms. This mechanism is the foundation of Celcuity’s strategy in oncology, particularly in hormone receptor-positive, HER2-negative advanced breast cancer and other solid tumors. The company has emphasized that gedatolisib is differentiated from therapies that target only one node of the pathway, which is central to its competitive positioning. Celcuity was founded by its co-founders, including Brian Sullivan and Lance Laing, and has built a management team focused on clinical development, regulatory affairs, and eventual commercialization. The business remains highly concentrated around a small number of programs, which can be positive in terms of focus but also creates binary trial and regulatory risk. In practice, that means the market’s attention is closely tied to study readouts, FDA interactions, and financing strategy. Recent company developments have been important. In November 2025, Celcuity announced completion of the submission of its New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2- advanced breast cancer, under the FDA’s Real-Time Oncology Review program. In March 2026, the company said that efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 study were published in the Journal of Clinical Oncology, providing additional peer-reviewed validation for the program. In May 2026, Celcuity also disclosed that its Phase 3 VIKTORIA-2 trial was expanding to include endocrine-sensitive patients, which broadens the potential addressable population. Overall, Celcuity is a specialized U.S. oncology biotech with a clear scientific thesis, a focused pipeline, and meaningful near-term catalysts. Its Nasdaq listing in the United States, combined with the recent regulatory and clinical progress around gedatolisib, makes it a high-risk, event-driven equity story rather than a diversified pharmaceutical platform.