Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU(R) (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium – The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the
Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU(R) (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023 – The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group,
Menarini Group Announces New Data on ORSERDU(R) (elacestrant) at the 2023 San Antonio Breast Cancer Symposium and on ELZONRIS(R) (tagraxofusp-erzs) at the 65th American Society of Hematology Annual Meeting and Exposition – - ORSERDU data reinforce its key role in the treatment of ER+, HER2- advanced or metastatic breast cancer (mBC) tumors that harbor ESR1 mutations, while showing initial data from combination
Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU(R) (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer – The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and SciClone Pharmaceuticals (Holdings) Ltd. ("SciClone"), an international biopharmaceutical company, today announced that they have
European Commission Approves Menarini Group's ORSERDU(R) (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation – The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, announced today that the European
Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU(R) (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation – The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, announced
Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU(R) (Elacestrant) in Metastatic Breast Cancer at ASCO 2023 – The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, today announced results from a new analysis of the pivotal EMERALD clinical study that suggest that oral
Menarini Group Announces New Data on Elacestrant at 2023 ESMO Breast Cancer Congress and 2023 ASCO Annual Meeting – Elacestrant has been approved by the FDA for treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine
Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDUTM (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer – The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU
Carrick Therapeutics and The Menarini Group Announce Clinical Trial Collaboration to Evaluate Samuraciclib and Elacestrant Combination – Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced a clinical trial collaboration and supply
Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant's PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting – The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini
Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer – The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, today announced that EMA has validated the
Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer – The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of Menarini Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug
Context Therapeutics and The Menarini Group Announce Clinical Trial Collaboration and Supply Agreement to Evaluate ONA-XR and Elacestrant Combination – Context to initiate Phase 1b/2 clinical trial in Q4 2022Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, and The Menarini Group
Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant – The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast
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 – The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") today announced the presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting of data
Menarini Group and Radius Health, Inc. announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology – The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") today announced that data from the pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as a monotherapy vs. standard of care (SOC;
Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021 – - In the overall population, elacestrant reduced risk of progression or death by 30% vs. SoC- In the mESR1 population, elacestrant reduced risk of progression or death by 45% vs. SoC- PFS rate at 12 months with elacestrant was 22.32% versus 9.42% with SoC in the overall population, and 26.76% versus 8.19% in
นำเสนอผลการทดลองในเชิงบวกจากโครงการ EMERALD เพื่อศึกษาประสิทธิภาพยา Elacestrant ในงาน San Antonio Breast Cancer Symposium 2021 – - ในกลุ่มประชากรโดยรวม ยา elacestrant ลดความเสี่ยงของการลุกลามของโรคหรือการเสียชีวิตได้ 30% เมื่อเทียบกับการรักษาแบบดูแลรักษาตามมาตรฐาน- ในกลุ่มประชากรที่มีการกลายพันธุ์ mESR1 ยา elacestrant ลดความเสี่ยงของการลุกลามของโรคหรือการเสียชีวิตได้ 45% เมื่อเทียบกับการรักษาแบบดูแลรักษาตามมาตรฐาน-
Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer – - 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 regulatory submissions
Menarini Group และ Radius Health ประกาศผลการศึกษาหลักเชิงบวกในการทดลองระยะ 3 จากโครงการ EMERALD เพื่อประเมินการใช้ยา Elacestrant ในการรักษามะเร็งเต้านม – - ยา Elacestrant เป็นยา SERD แบบรับประทานตัวแรกที่แสดงผลการศึกษาหลักเชิงบวกในการทดสอบสำคัญในฐานะยาเดี่ยวเทียบกับ SoC สำหรับการรักษามะเร็งเต้านมระยะลุกลามชนิดที่มีผลบวกต่อตัวรับฮอร์โมนและผลลบต่อตัวรับเฮอร์ทู (ER+/HER2-) หรือระยะแพร่กระจาย (mBC)- ยา Elacestrant ยืดเวลา PFS
Radius Health & Menarini Group Provide Elacestrant Update – - Life cycle planning advancing in parallel with current Phase 3 monotherapy programRadius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS) and the Menarini Group today announced an update on the elacestrant Phase 3 EMERALD trial.EMERALD Phase 3 StudyThe target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant.
Menarini Group และ Radius Health บรรลุข้อตกลงอนุญาตใช้สิทธิทั่วโลก เพื่อพัฒนาและจำหน่ายยา Elacestrant – - Elacestrant จะเข้ามาเสริมแกร่งกลุ่มผลิตภัณฑ์ยารักษามะเร็งของ Menarini หลังจากที่บริษัทเพิ่งซื้อกิจการ Stemline Therapeutics ในสหรัฐอเมริกาเมื่อไม่นานมานี้- Radius จะได้รับเงินล่วงหน้า 30 ล้านดอลลาร์ และเงินเพิ่มเติมสูงสุด 320 ล้านดอลลาร์ตามความคืบหน้าในระดับต่าง ๆ พร้อมรับค่าสิทธิราว 10-15%Menarini Group และ Radius
Menarini Group and Radius Health Announce Global License Agreement for the Development and Commercialization of Elacestrant – - Elacestrant further strengthens Menarini's global oncology portfolio, recently bolstered by the acquisition of Stemline Therapeutics in the U.S.- Radius will receive $30M as an upfront payment and up to $320M in additional milestones along with tiered low to mid-teen percentage royaltiesThe