[{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Journal of Clinical Psychiatry Publishes Data from Alkermes' Phase 3 ENLIGHTEN-1 Efficacy Study","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Publication of Preclinical Data for ALKS 4230 in the Journal for ImmunoTherapy of Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Schizophrenia Portfolio at Virtual 2020 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Journal of Clinical Psychiatry Publishes Data from Alkermes' ALPINE Study in Patients With Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Colvis Oncology","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Preclinical Data on ALKS 4230 in Combination With Lucitanib to be Presented at 2020 AACR Virtual Annual Meeting II","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Initiates Phase 2 Study to Evaluate Clinical and Immunologic Activity of ALKS 4230 in Patients with Advanced Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virtual FDA Advisory Committee Meeting to Review Alkermes' New Drug Application for ALKS 3831 in Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes to Present New Data on Investigational Immuno-Oncology Candidate, ALKS 4230, at the 2020 ESMO Virtual Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Psychiatry Data at Psych Congress 2020 Virtual Experience","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 ESMO Virtual Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alkermes Inks Clinical Trial Collaboration With MSD to Evaluate Nemvaleukin Alfa in Combination With KEYTRUDA in Patients Ovarian Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout Mental Health Awareness Month","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presented New Data Analysis on Healthcare Resource Use Among Veterans With Alcohol Dependence","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces FDA Approval of LYBALVI\u2122 for the Treatment of Schizophrenia and Bipolar Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes to Present Data on Nemvaleukin Alfa at the Society of Gynecologic Oncology 2022 Annual Meeting on Women's Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Psychiatry Portfolio at 2022 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Four Abstracts Accepted for Presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents ARTISTRY-1 Data at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Awarded Innovation Passport Designation by the MHRA (UK) for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI\u00ae (olanzapine and samidorphan)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Mural Oncology","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mural Oncology Announces Enhancements to Late-Stage Clinical Trials","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Alkermes Plc
Nemvaleukin is an innovative engineered interleukin-2 (IL-2) variant designed to harness the potent anti-cancer capabilities of high-dose rhIL-2. It is under phase 3 clinical development for the treatment of patients with platinum-resistant epithelial ovarian cancer.
Lybalvi (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug. It is approved by USFDA for treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.
ALKS 4230 (nemvaleukin alpha) is an investigational, novel, fusion protein comprised of modified IL-2 and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells.
The results of ARTISTRY-1 for nemvaleukin alfa (ALKS 4230), demonstrated that selectively targeting IL-2 pathway may deliver significant clinical benefit in multiple tumor types while mitigating hallmark toxicities associated with high-dose recombinant-IL-2.
ALKS 4230 (nemvaleukin), an investigational, novel, engineered fusion protein comprised of modified interleukin-2 and high-affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells.
LYBALVI (olanzapine and samidorphan), an atypical antipsychotic drug approved in U.S. for treatment of adults with schizophrenia and for treatment of adults with bipolar I disorder.
Nemvaleukin, an engineered fusion protein comprised of modified interleukin-2 and IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding activation of immunosuppressive cells by selectively binding to IL-2 receptor complex.
The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.
The study assessed treatment patterns and HRU among 3,665 patients diagnosed with alcohol dependence who were treated with VIVITROL® (naltrexone for extended-release injectable suspension (XR-NTX)).
In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.