the Menarini Group and Radius Health, Inc. announced positive topline results from the EMERALD study. The study was designed to evaluate elacestrant as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC). There were two primary endpoints: progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring estrogen receptor 1 (ESR1) mutations. EMERALD met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup. The safety profile of elacestrant exhibited in EMERALD was similar to that of the previous clinical trial. Given these results, Menarini and Radius plan on proceeding with regulatory submissions in both the United States and European Union in 2022. In 2018, elacestrant received fast track designation from the FDA. Elacestrant is a selective estrogen receptor degrader (SERD). It was being investigated in the Phase 3 EMERALD trial as a potential once daily, oral treatment, in patients with ER+/HER2- mBC. Overall, 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation. ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/HER2- mBC patients.