Context Therapeutics Inc (NASDAQ:CNTX) shares are trading higher by 60.32% to $1.10 Tuesday afternoon after the company announced its clinical trial collaborator, Stemline Therapeutics, received approval from the FDA for ORSERDU in ER+, HER2-, ESR1-mutated breast cancer.
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Context Therapeutics says ORSERDU has shown improved efficacy over the current standard-of-care (SOC) treatment, fulvestrant, in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
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“This is a watershed moment for the industry, which has spent the last 20 years trying to develop a next-generation endocrine therapy that is pharmacologically superior to endocrine monotherapies, including fulvestrant,” said Martin Lehr, CEO of Context Therapeutics, said in part of a statement Tuesday.
“ORSERDU has the potential to fundamentally change the treatment paradigm for patients with ESR1-mutated breast cancer, which is found in approximately 40% of the estimated 43,500 patients with metastatic hormone-driven breast cancer in the United States.”
According to data from Benzinga Pro, CNTX has a 52-week high of $2.79 and a 52-week low of $0.60.
