Radius Health, Inc. (NASDAQ: RDUS) is engaged as a global biopharmaceutical company, which is focused on unmet medical needs in bone health, orphan diseases, and oncology. Shares of the biopharma are rallying 28% through early trading on Wednesday, October 20, 2021. Over the past three months, Radius Health has seen average daily volume of 400,220 shares. However, volume of 33.31 million shares or dollar volume of $658.21 million, has already exchanged hands through early trading on Wednesday.
Shares of Radius Health are gaining today after the company and the Menarini Group announced positive topline results from its EMERALD Phase 3 clinical study for the treatment of metastatic breast cancer. The clinical study evaluated elacestrant as a monotherapy compared to the standard of care for treatment of advanced breast cancer.
Elacestrant is a selective estrogen receptor degrader (SERD). The Phase 3 EMERALD trial tested utilizing elacestrant as a once daily, oral treatment in patients with metastatic breast cancer. In the 466 patients enrolled in the study, 220 patients or 47% of the study group had tumors with an estrogen receptor 1 mutuation.
The biopharma company says the study focused on two primary endpoints: progression-free survival in overall population and progression-free survival in patients with tumors containing estrogen receptor 1 mutations.
The Phase 3 EMERALD study met both primary endpoints showing statistically significant progression-free survival in both groups. The safety of elacestrant was shown to be similar to its previous clinical studies.
As a result of the strong Phase 3 trials, Radius Health and Menarini Group will begin to focus on regulatory submissions to both U.S. and European officials beginning in 2022. The FDA had previously granted elacestrant fast track designation in 2018.
“Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need. Additional therapeutic options for this patient population are urgently needed,” said Dr. Aditya Bardia, MD, MPH of the MGH, Associate Professor at the Medicine Department at Harvard Medical School, and Principal Investigator for the EMERALD trial. “The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors. The results provide a significant advancement for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy.”
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