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MINNEAPOLIS - Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company with a market capitalization of $2.2 billion and one of the best-performing biotech stocks with a 394% gain over the past six months according to InvestingPro, announced Monday that data from its Phase 3 VIKTORIA-1 trial will be presented at the European Society of Medical Oncology (ESMO) Congress taking place October 17-21, 2025.
The presentation, scheduled for October 18, will reveal detailed efficacy and safety results from the PIK3CA wild-type cohort of patients with hormone receptor-positive, HER2-negative advanced breast cancer treated with gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant alone.
Gedatolisib, the company’s lead therapeutic candidate, is a pan-PI3K and mTORC1/2 inhibitor that targets the PAM pathway. According to the company’s press release, the drug’s mechanism of action differs from other approved and investigational therapies that target components of this pathway individually.
The VIKTORIA-1 trial has completed enrollment for its PIK3CA wild-type cohort and reported topline data, while the PIK3CA mutant cohort is still enrolling patients. Celcuity is also conducting a Phase 1/2 trial of gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer, and a Phase 3 trial evaluating gedatolisib with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer.
The presentation at ESMO has been selected as a late-breaking abstract for an oral presentation, indicating the potential significance of the findings in the field of breast cancer treatment.
Celcuity is a clinical-stage biotechnology company focused on developing targeted cancer therapies and is headquartered in Minneapolis. While currently operating at a loss with -$146.49M in EBITDA, the company maintains a strong liquidity position with a current ratio of 4.58. For detailed financial analysis and 14 additional ProTips about CELC, visit InvestingPro.
In other recent news, Celcuity Inc. has made significant strides in its cancer drug development efforts. The company announced an amendment to its senior secured credit facility with Innovatus Capital Partners and Oxford Finance, raising the total term loan facility to $500 million. This agreement includes $350 million in committed capital, with an initial funding of $30 million received, bringing the total outstanding term loan to $130 million. Additionally, the U.S. Food and Drug Administration has accepted Celcuity’s New Drug Application for gedatolisib under the Real-Time Oncology Review program, potentially expediting the evaluation process.
Analysts have responded positively to these developments, with Guggenheim initiating coverage on Celcuity with a Buy rating, citing the significant sales potential of gedatolisib in second-line breast cancer treatment. H.C. Wainwright raised its price target for Celcuity from $50 to $66, maintaining a Buy rating, following the company’s second-quarter financial results. Stifel also increased its price target to $68, emphasizing the potential of gedatolisib and Celcuity’s plans to present further data by year-end. These recent developments indicate a period of strategic growth and potential for Celcuity as it advances its cancer treatment pipeline.
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