Stock's Year-to-Date Increase by 215%, Consider Buying it Before further Gains are Missed?
Celcuity, a clinical-stage biotechnology company, has made a significant stride in the fight against breast cancer with its experimental drug, Gedatolisib. This pan-PI3K, mTORC1, and mTORC2 inhibitor shows potent antitumor activity and has the potential to overcome resistance mechanisms found in tumors resistant to single-target PAM inhibitors.
Mechanism of Action and Potency
Gedatolisib targets all class I PI3K isoforms plus both mTOR complexes (mTORC1 and mTORC2), leading to a complete shutdown of the PAM signaling pathway that often drives breast cancer cell growth and survival. In preclinical data, Gedatolisib is about 300 times more potent than inhibitors targeting only individual PAM components.
Indication and Clinical Trial
Gedatolisib is intended for treating hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, one of the most common and deadly subtypes of breast cancer. Recently, Celcuity announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.
The trial evaluated Gedatolisib in combination with fulvestrant, with or without palbociclib (a CDK4/6 inhibitor), in patients with locally advanced or metastatic HR+/HER2- breast cancer who had progressed on prior CDK4/6 inhibitors and aromatase inhibitors.
Outcomes
The results showed significant improvement in progression-free survival (PFS):
- The triplet regimen (Gedatolisib + palbociclib + fulvestrant) reduced the risk of progression or death by about 76% compared to controls.
- The doublet regimen (Gedatolisib + fulvestrant) reduced risk by about 67%.
These findings position Gedatolisib as a promising new therapeutic option for HR+/HER2- breast cancer patients with resistance to current endocrine and CDK4/6 inhibitor therapies.
Financial Implications
The positive results have led to a surge of more than 215% in Celcuity's stock price year-to-date. H.C. Wainwright raised the target price to $50 and assigned a "Buy" rating. Out of the eight analysts that cover the stock, seven rate Celcuity a "Strong Buy," and one suggests a "Moderate Buy."
However, Celcuity remains a high-risk investment due to potential clinical trial failures or delays in regulatory approval. As of the end of its first quarter, which ended on March 31, Celcuity had $205.7 million in cash and equivalents, and management has stated that current resources are sufficient to fund operations until 2026.
Celcuity's focus is improving cancer treatment through its drug, Gedatolisib, and the CELsignia platform. The company is currently conducting Phase 3 clinical trials in breast cancer (VIKTORIA 1 and VIKTORIA 2) and a Phase 1/2 trial in prostate cancer.
[1] Celcuity. (2025). Celcuity Announces Positive Topline Results from Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib in HR+/HER2- Advanced Breast Cancer. [Press Release]
[2] Celcuity. (2025). Celcuity Announces Positive Topline Results from Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib in HR+/HER2- Advanced Breast Cancer. [Fact Sheet]
[3] Celcuity. (2025). Celcuity Announces Positive Topline Results from Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib in HR+/HER2- Advanced Breast Cancer. [Investor Presentation]
[4] Leerink. (2025). Leerink Raises Celcuity Price Target to $60. [Research Note]
[5] H.C. Wainwright. (2025). H.C. Wainwright Raises Price Target on Celcuity to $50. [Research Note]
In the realm of health-and-wellness, Celcuity's experimental drug, Gedatolisib, presents a potential solution for medical-conditions like breast cancer. This pan-PI3K, mTORC1, and mTORC2 inhibitor, shown to be 300 times more potent than single-target PAM inhibitors, could revolutionize finance for investors by offering promising returns, as indicated by a surge of over 215% in Celcuity's stock price year-to-date. However, with the potential for clinical trial failures or delays in regulatory approval, investing in Celcuity remains a high-risk venture.
