Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients Priority Review requested; if accepted, anticipate an 8-month FDA review Positive EMERALD study data previously announced on October 20, 2021 First, and currently only, investigational oral SERD with positive topline results Additional data presented at SABCS (December 2021) and ASCO (June 2022) Plan […]

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23 มิ.ย. 65

Menarini Group and Radius Health, Inc. present a subgroup analysis from the elacestrant pivotal phase 3 EMERALD clinical trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Subgroup analysis of patients with no prior chemotherapy in EMERALD: A phase 3 trial evaluating elacestrant, an investigational oral selective estrogen receptor degrader (SERD), vs. investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC) The Menarini Group (“Menarini”) and Radius Health, Inc. (“Radius”) (NASDAQ: RDUS) (collectively, the “Companies”) today…

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8 มิ.ย. 65

Menarini Group and Radius Health, Inc. announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology

Emerald study met both its primary end points of Progression-free survival (PFS) in overall population and in ESR1 mutated patients PFS rate at 12 months with elacestrant was 22.32% vs. 9.42% with SOC in the overall population, and 26.76% vs. 8.19% in the ESR1 mutation population Data demonstrated elacestrant significantly reduced the risk of disease progression or […]

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23 พ.ค. 65

Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021

– Trial met both primary endpoints demonstrating statistically significant and clinically meaningful extension of progression free survival (PFS) as monotherapy vs. standard of care (SoC) endocrine therapy in overall population and estrogen receptor mutation (mESR1) population – In the overall population, elacestrant reduced risk of progression or death by 30% vs. SoC – In the mESR1 population, […]

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13 ธ.ค. 64

Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer

– Study met both primary endpoints in patients with ER+/HER2- advanced or mBC – Elacestrant becomes the first oral SERD with positive topline results in pivotal study as a monotherapy versus SoC for the treatment of ER+/HER2- advanced or mBC – Elacestrant extended PFS in the overall population and the ESR1 mutation subgroup – Plans for […]

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21 ต.ค. 64