Quick Read
- Celcuity’s stock surged over 100% following historic Phase 3 trial results for its breast cancer drug, gedatolisib.
- The drug demonstrated a 76% risk reduction in disease progression with triplet therapy, marking unprecedented efficacy.
- Gedatolisib’s multi-target mechanism and favorable safety profile make it a strong candidate for FDA approval.
- Celcuity plans to file for FDA approval in Q4 2025, with further data to be presented later this year.
Celcuity Inc. (NASDAQ: CELC), a clinical-stage biotechnology company, made headlines on July 28, 2025, with the announcement of groundbreaking results from its Phase 3 VIKTORIA-1 trial for the breast cancer drug gedatolisib. The news catapulted the company’s stock by over 100% in pre-market trading, marking a major milestone for both Celcuity and the broader medical community.
Unprecedented Results in Advanced Breast Cancer Treatment
The VIKTORIA-1 trial focused on patients with hormone receptor-positive (HR+), HER2-negative, PIK3CA wild-type advanced breast cancer—a challenging group to treat effectively. The study tested gedatolisib in combination with existing drugs like fulvestrant and palbociclib. The results were nothing short of historic:
- The gedatolisib triplet therapy reduced the risk of disease progression or death by an extraordinary 76% (HR=0.24), with a median progression-free survival (PFS) of 9.3 months, compared to just 2.0 months for fulvestrant alone.
- The gedatolisib doublet therapy showed a 67% risk reduction (HR=0.33), with a median PFS of 7.4 months.
These findings represent a significant leap in the treatment of HR+/HER2- advanced breast cancer, particularly for PIK3CA wild-type patients, who have historically lacked effective targeted therapies. Dr. Sara Hurvitz, co-principal investigator of the trial and Senior Vice President at the Fred Hutchinson Cancer Center, described the results as “potentially practice-changing,” noting the quadrupling of progression-free survival compared to the control group.
What Sets Gedatolisib Apart?
Gedatolisib’s unique mechanism of action is a major factor behind its success. Unlike existing therapies that target a single component of the PI3K/AKT/mTOR pathway, gedatolisib inhibits all four class I PI3K isoforms, mTORC1, and mTORC2. This multi-target approach not only enhances efficacy but also reduces tumor resistance, making it particularly effective in PIK3CA wild-type patients who typically do not respond well to single-target inhibitors.
Another critical differentiator is its safety profile. Gedatolisib demonstrated lower rates of hyperglycemia and stomatitis, common side effects associated with similar drugs. Additionally, treatment discontinuation rates were significantly lower than those observed in previous Phase 1b and Phase 3 trials for comparable therapies. These attributes make gedatolisib a strong candidate for broader clinical use.
Market Reaction and Analyst Sentiment
The stock market reacted swiftly to the announcement, with Celcuity’s shares surging by 212% during pre-market trading. By mid-day, the stock was trading at approximately $16.19, more than double its value prior to the news. Analysts have taken note, with Wall Street maintaining a consensus “Strong Buy” rating for the stock. The average price target now stands at $28.25, representing a potential upside of over 105%.
The trial’s success has also elevated Celcuity’s market cap to $532 million, further solidifying its position as a rising star in the biotechnology sector. Institutional ownership remains robust at 82%, reflecting strong investor confidence in the company’s future prospects.
Next Steps: Regulatory Approvals and Data Presentation
Celcuity has outlined an ambitious timeline for the next phases of gedatolisib’s development. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. Additionally, full data from the PIK3CA wild-type cohort will be presented at a major medical conference later this year, with topline results from the PIK3CA mutation cohort expected by year-end.
Should the FDA grant approval, gedatolisib could become the first PI3K/AKT/mTOR pathway inhibitor to demonstrate efficacy in PIK3CA wild-type advanced breast cancer, addressing a critical unmet need in oncology.
Broader Implications for Breast Cancer Treatment
HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases. For patients who progress after first-line CDK4/6 inhibitor therapy, treatment options are often limited. Gedatolisib’s success in this Phase 3 trial has the potential to redefine the standard of care for this patient population, offering new hope to thousands of individuals worldwide.
Dr. Igor Gorbatchevsky, Celcuity’s Chief Medical Officer, emphasized the significance of the results, stating, “Gedatolisib’s mechanism of action is differentiated and addresses a critical unmet need. These findings could transform how we approach treatment for advanced breast cancer.”
In conclusion, Celcuity’s groundbreaking Phase 3 trial results for gedatolisib mark a pivotal moment in the fight against advanced breast cancer. With regulatory approvals on the horizon, the drug could soon set a new benchmark for efficacy and safety, offering renewed hope to patients and their families.