Celcuity (CELC) shares dropped over 25% despite Phase 3 VIKTORIA-1 data confirming gedatolisib's best-in-class efficacy in advanced breast cancer. Gedatolisib demonstrated superior progression-free survival and objective response rates versus current standards, supporting blockbuster potential in a $6bn market. FDA approval for HR+/HER2- PIK3CA wild-type breast cancer is expected by July 2026, with a supplementary NDA for the mutant cohort planned.
Celcuity Inc. (CELC) Discusses VIKTORIA-1 Trial Results for PIK3CA Mutant Advanced Breast Cancer and Gedatolisib Efficacy Transcript
Celcuity Inc. (CELC) Q1 2026 Earnings Call Transcript
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
Farallon Capital Farallon Capital Management LLC | 4,000 | $398,960 | $355,800 | -$43,160 | -10.82% |
John H. Burbank III Passport Capital LLC | 7.92M | $196.34M | $704.11M | $507.77M | 258.62% |
Point72 Asset Management LP Point72 Asset Management LP | 280,324 | $32M | $24.93M | -$7.06M | -22.07% |
Schwarz Dygos Wheeler Investment Schwarz Dygos Wheeler Investment Advisors LLC | 5,940 | $27,675.18 | $528,363 | $500,687.82 | 1,809.16% |
| CCP Christopher C. Powers Farther Finance Advisors, LLC | 5 | $247.22 | $444.75 | $197.53 | 79.9% |
| Biotechnology Industry | Healthcare Sector | Brian F. Sullivan CEO | NASDAQ (CM) Exchange | 15102K100 CUSIP |
| US Country | 87 Employees | - Last Dividend | - Last Split | - IPO Date |
Celcuity Inc. is a clinical-stage biotechnology company based in Minneapolis, Minnesota, established in 2011. It is primarily engaged in the development of targeted therapies for the treatment of various solid tumors. By focusing on personalized medicine, Celcuity aims to advance the treatment of cancer through its innovative CELsignia diagnostic platform. This platform utilizes living tumor cells from patients to pinpoint the specific abnormal cellular processes driving their cancer. An essential aspect of their operation includes a strategic license agreement with Pfizer, Inc., granting them the development and commercialization rights to Gedatolisib, one of their leading drug candidates.
This groundbreaking platform represents the core of Celcuity's technological advancement. It is designed to analyze living tumor cells to determine the specific abnormal cellular activity causing a patient's cancer. The analysis enables the identification of targeted therapies that are most likely to be effective for each patient, personalizing the treatment approach to cancer care.
As a leading drug candidate in Celcuity's portfolio, Gedatolisib is being developed to selectively target and inhibit the activity of class I isoforms of phosphoinositide 3-kinase (PI3K) and mammalian target of rapamycin (mTOR). These enzymes are often involved in the growth and spread of cancer cells. Gedatolisib is currently focused on the treatment of patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, and metastatic castration-resistant prostate cancer. The development and potential commercialization of Gedatolisib are underpinned by a license agreement with Pfizer, Inc., illustrating Celcuity's collaborative efforts with industry leaders to bring new cancer therapies to market.