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Celcuity Inc. (CELC) stock surged about 221% on Monday morning after the company announced that its experimental combination treatment demonstrated a reduction in the risk of disease progression or death in patients with a type of advanced breast cancer in a late-stage study.
The firm said that the combination of Gedatolisib, Fulvestrant, and Palbociclib reduced the risk of disease progression or death by 76% compared to Fulvestrant alone in patients with previously treated HR+/HER2- advanced breast cancer.
Median progression-free survival was 9.3 months with the Gedatolisib triplet compared to two months with Fulvestrant alone, meaning patients lived an average of 9.3 months without progression of disease with the treatment.
A combination of Gedatolisib plus Fulvestrant reduced the risk of disease progression or death by 67% compared to Fulvestrant, with a median progression-free survival of 7.4 months.
On Stocktwits, retail sentiment around Celcuity trended in the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.
A Stocktwits user opined that they expect a peak market valuation of three to five billion dollars for the company.
Another said that the news is worth at least a 500% rally.
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. According to Celcuity, HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.
The improvements in progression-free survival observed in the study with the combinations were statistically significant and clinically meaningful, the company said.
Both the combinations were better tolerated than observed in an early-stage trial in patients with advanced breast cancer, it added.
Sara Hurvitz, co-principal investigator for the trial, said that the data for both combination treatments in the trials are “potentially practice-changing.”
“The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population,” CEO Brian Sullivan added.
Celcuity expects to submit a new drug application for Gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025.
CELC stock is up by about 238% this year and by 147% over the past 12 months.
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