Celcuity (CELC), a clinical-stage biotechnology company, has quietly surged more than 215% year-to-date, turning heads on Wall Street.
While larger names in oncology dominate headlines, this under-the-radar cancer drug developer is making a name for itself by advancing an innovative approach to treating hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer, one of the most common and deadly subtypes of breast cancer.
The company announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial on Monday, which fueled the stock rally. Let’s find out if it is the right time to grab this growth stock before it soars any higher.
What Does Celcuity Do?
Valued at $1.39 billion, Celcuity is a clinical-stage biotechnology company that aims to improve cancer treatment through two key innovations: a drug called gedatolisib and a specialty diagnostic tool called the CELsignia platform. The company’s experimental drug, gedatolisib, is intended to block the PI3K and mTOR signaling pathways inside cancer cells, which help tumors grow and resist existing treatments.
Unlike drugs that target only one part of this pathway, gedatolisib’s mechanism of action inhibits multiple components at once, which may make it more effective. Celcuity is conducting Phase 3 clinical trials in breast cancer (VIKTORIA 1 and VIKTORIA 2) as well as a Phase 1/2 trial in prostate cancer to assess the efficacy of this drug in comparison to current treatments.
What Led to the Dramatic Surge in CELC Stock?
On July 28, Celcuity revealed positive results in patients with advanced HR-positive/HER2-negative breast cancer who did not have PIK3CA mutations (PIK3CA wild-type) and had previously received CDK4/6 inhibitors and hormone blockers. Patients were randomly assigned to one of two treatment groups, both of which included Celcuity’s experimental drug gedatolisib:
- Triplet therapy with gedatolisib, palbociclib (Pfizer’s (PFE) Ibrance), and fulvestrant reduced the risk of disease progression or death by approximately 76%.
- Doublet therapy with gedatolisib and fulvestrant reduced risk by 67%.
This is the first Phase 3 breast cancer trial in which a PI3K/mTOR inhibitor has demonstrated strong efficacy in PIK3CA wild-type patients. It suggests that gedatolisib acts on multiple targets. Celcuity intends to submit a New Drug Application (NDA) to the FDA in the fourth quarter based on topline data. The new combination therapy significantly delayed cancer progression in the trial groups while causing no major new side effects, representing a breakthrough in this difficult-to-treat group. Investors are optimistic about a potential FDA approval late in 2025 and the possibility of a change in treatment options for many patients.
Furthermore, the company has dosed the first patient in the VIKTORIA-2 Phase 3 trial. Celcuity had $205.7 million in cash and equivalents at the end of its first quarter, which ended on March 31. Operating expenses have steadily increased as the company expands its clinical footprint, but management has stated that current resources are sufficient to fund operations until 2026.
Is Celcuity Stock a Buy Now?
On Wall Street, overall, Celcuity stock is a “Strong Buy.” Out of the eight analysts that cover the stock, seven rate it a “Strong Buy,” and one suggests a “Moderate Buy.” Led by the dramatic surge on Monday, the stock has surpassed its average target price of $28.71. However, following the positive trial results, Leerink increased the stock’s target price to $60, implying 53% upside potential from current levels. In addition, H.C. Wainwright raised the target price to $50 and assigned a “Buy” rating.
The Bottom Line
If the VIKTORIA-1 trial is successful, Celcuity could quickly become a commercial-stage company, given the size of the HR+/HER2− breast cancer market. However, despite its strong trajectory, Celcuity remains a high-risk investment. As with any biotech company in a critical development stage, risks include clinical trial failures or delays in regulatory approval, all of which can cause massive stock swings (both up and down). As a result, Celcuity stock remains a solid pick for investors with a long-term mindset and a high risk tolerance who are willing to deal with the short-term volatility.
On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. For more information please view the Barchart Disclosure Policy here.
