[{"orgOrder":0,"company":"Stemline Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Stemline Therapeutics Announces Preliminary 2019 Net Revenues for ELZONRIS\u00ae (tagraxofusp) and Highlights Commercial and Clinical Growth Drivers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Menarini","sponsor":"Stemline Therapeutics","pharmaFlowCategory":"D","amount":"$677.0 million","upfrontCash":"$677.0 million","newsHeadline":"Menarini Group to Acquire Stemline Therapeutics in Transaction Valued at Up to $677 Million","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"May 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Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Radius Health & Menarini Group Provide Elacestrant Update","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Glenmark Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Glenmark Pharmaceuticals and Menarini enter into Exclusive Licensing Agreement for commercializing Ryaltris\u2122 Nasal Spray in Europe","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Receives European Commission Approval of ELZONRIS, for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Nippon Shinyaku","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Menarini Group and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize ELZONRIS\u00ae (Tagraxofusp) in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Peptide","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Ryvu Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ryvu Therapeutics Presents Positive Phase I Data for RVU120 at the Virtual 26th Annual Congress of the European Hematology Association","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Menarini","sponsor":"Lipidor AB","pharmaFlowCategory":"D","amount":"$83.1 million","upfrontCash":"Undisclosed","newsHeadline":"Lipidor AB Licence Agreement Grants Menarini Group Exclusive Rights to Two New Psoriasis Drug Candidates for Potential Value of MEUR 70","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Ryvu Therapeutics","pharmaFlowCategory":"DU","amount":"Not 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Announce Publication of Elacestrant Pivotal Phase 3 EMERALD Clinical Trial Data in The Journal of Clinical Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Karyopharm Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO\u00ae (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group\u2019s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+\/HER2- Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 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Myelofibrosis","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant\u2019s PFS Increases with Duration of Prior CDK4\/6i in ER+, HER2- in Metastatic Setting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Stemline Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Stemline Therapeutics, a Subsidiary of Menarini Group, Receives U.S. FDA Approval for Orserdu\u2122 (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"NewAmsterdam Pharma","pharmaFlowCategory":"D","amount":"$1,061.5 million","upfrontCash":"$121.0 million","newsHeadline":"NewAmsterdam Pharma and The Menarini Group Sign Licensing Deal to Commercialize Obicetrapib in Europe","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Menarini","sponsor":"Karyopharm Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO\u00ae (selinexor) in Combination with Bortezomib and Dexamethasone for the Treatment of Adult Patients with Multiple M","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU\u00ae (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Nippon Shinyaku","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The Menarini Group Announces ELZONRIS\u00ae (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"August 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Phase II","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Menarini Group\u2019s ORSERDU\u00ae (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"Lupin Ltd","pharmaFlowCategory":"D","amount":"$12.1 million","upfrontCash":"Undisclosed","newsHeadline":"Lupin Inks Pact to Acquire 5 Drug Brands from Menarini for Rs 101 Crore","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"European Organisation for Research and Treatment of Cancer","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Organisation for Research and Treatment of Cancer & the Menarini Group Launch New Clinical Trial in Early-Stage Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"SciClone Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU\u00ae (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Menarini","sponsor":"VenatoRx Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Venatorx Pharmaceuticals and Menarini Group Enter Commercial Agreement for Cefepime-Taniborbactam in 96 Countries","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Stemline Therapeutics","sponsor":"Insilico Medicine","pharmaFlowCategory":"D","amount":"$512.0 million","upfrontCash":"$12.0 million","newsHeadline":"Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"}]
Find Clinical Drug Pipeline Developments & Deals by Menarini
Menarini will acquire rights to commercialize, upon approval, VNRX-5022/VNRX-5133 (cefepime-taniborbactam), an investigational IV beta-lactam/beta-lactamase inhibitor antibiotic combination for complicated urinary tract infections, in 96 countries.
Under the agreement, Stemline will have the global rights to develop and commercialize a novel, small molecule KAT6A inhibitor designed using Insilico’s AI platform, as a potential treatment for hormone sensitive cancers and other oncology indications.
Under the agreement, SciClone will pursue the development and registration of Orserdu (elacestrant), a once-daily oral endocrine monotherapy, for the treatment of postmenopausal women or adult men, in China and commercialize Orserdu upon its regulatory approval in China.
Orserdu (elacestrant), an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα), is indicated for the treatment of postmenopausal women, and men, with ER‑positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.
The company has signed an agreement to acquire five legacy brands are Piclin, Menoctyl (Otilonium Bromide), Sucramal O (Sucralfate + Oxetacaine), Pyridium (Phenazopyridine) and Distaclor (Cefaclor) catering to gastroenterology, urology and anti-infective segments.
Orserdu (elacestrant), an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα), is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer.
MEN1703 (SEL24) is a first-in-class, dual PIM/FLT3 kinase inhibitor with a unique activity profile, which is investigated for the treatment of diffuse large B-cell lymphoma.
Under the agreement, Menarini will develop, manufacture and commercialise orally administered Janus kinase (JAK) inhibitor Smyraf Tablets (generic name: peficitinib hydrobromide) in Taiwan for the treatment of rheumatoid arthritis.
ELZONRIS® (tagraxofusp), a recombinant protein is the only approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
Orserdu (elacestrant), an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα), is indicated for the treatment of postmenopausal women, and men, with ER‑positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.
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