Summary
Celcuity: 'Buy' REVTORPYK FDA Approval First And sNDA Label Expansion Q3 2026
Celcuity Inc. secured FDA approval for REVTORPYK, the first pan-PI3K, mTORC1/2 inhibitor for 2nd-line PIK3CA wild-type HR+/HER2- advanced breast cancer. I downgrade CELC from Strong Buy to Buy due to phase 3 mutant cohort data underperforming prior results and rising competitive threats from Relay Therapeutics. REVTORPYK demonstrated strong efficacy in both wild-type and mutant cohorts, but delayed commercial launch and potential for superior competitor data temper near-term enthusiasm.
Celcuity Enters Commercial Stage as FDA Approves REVTORPYK for Advanced Breast Cancer
Celcuity NASDAQ: CELC said the U.S. Food and Drug Administration has granted full approval to gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, marking the company's transition to a commercial-stage business.
Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Celcuity Inc. Investors
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| CE Curtis Ellergodt Rothschild Investment LLC | 82 | $1,773.41 | $7,306.2 | $5,532.79 | 311.99% |
| JD Jim Dushek HARBOUR INVESTMENTS Inc. | 1,000 | $114,140 | $88,570 | -$25,570 | -22.4% |
 Farallon Capital Farallon Capital Management LLC | 4,000 | $398,960 | $355,680 | -$43,280 | -10.85% |
| SN Stephanie Nee HARBOR CAPITAL ADVISORS Inc. | 6,807 | $369,542.16 | $605,278.44 | $235,736.28 | 63.79% |
| BG Bart Gancher Intech Investment Management LLC | 9,590 | $141,580.89 | $850,249.4 | $708,668.51 | 500.54% |
Celcuity Inc. Analysts
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| EFV Eva Fortea Verdejo Wells Fargo | 82.71 | $8,224.78 | $7,306.18 | -$918.6 | -11.17% |
| AN Alexander Nowak Craig-Hallum | 1,129.31 | $100,218.1 | $98,949.75 | -$1,268.35 | -1.27% |
Celcuity Inc. (CELC) FAQ
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Celcuity Inc. Profile
| Biotechnology Industry | Healthcare Sector | Brian F. Sullivan CEO | NASDAQ (CM) Exchange | 15102K100 CUSIP |
| US Country | 155 Employees | - Last Dividend | - Last Split | - IPO Date |
Overview
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.
Products and Services
- CELsignia Diagnostic Platform:
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.
- Gedatolisib:
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.
