News releases from Alkermes plc
NIDA-Funded Study Evaluating Extended-Release Injectable Naltrexone Plus Bupropion for the Treatment of Methamphetamine Use Disorder Published in New England Journal of Medicine
January 14, 2021
Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three...
Alkermes plc (Nasdaq: ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 39th Annual J.P. Morgan Healthcare Conference. The...
Alkermes Announces Updates to Executive Leadership Team
January 06, 2021
-- Blair C. Jackson Appointed Chief Operating Officer and Iain M. Brown Named Chief Financial Officer, Positioning Company for Continued Strong Execution of Business Strategy --
FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
December 29, 2020
Alkermes Announces Strategic Value Enhancement Plan and Continued Board Refreshment
December 10, 2020
- Commits to Non-GAAP Net Income Margin Targets of ~25% for FY 2023 and ~30% for FY 2024, Reflecting Rigorous Expense Management, Expected Revenue Growth and Commitment to Shareholder Value Creation -
Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review
November 17, 2020
-- No Clinical Efficacy or Safety Issues Raised and No Further Studies Required by FDA to Support Approval --
Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting
November 09, 2020
- Subcutaneous Dosing of ALKS 4230 in ARTISTRY-2 Showed Desired Immune Response and Safety Profile Consistent With the Observed Effects of Intravenous ALKS 4230 -
Alkermes Reschedules Third Quarter 2020 Financial Results Conference Call to 10:30 a.m. ET
October 29, 2020
Alkermes plc (Nasdaq: ALKS) announces that the conference call to discuss the company's third quarter financial results is rescheduled due to technical difficulties impacting the conference call...
Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations
October 29, 2020
- Company Reports Third Quarter Revenues of $265.0 Million, GAAP Net Loss per Share of $0.00 and Basic and Diluted Non-GAAP Earnings per Share of $0.26 -
Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020 to discuss the company's third quarter 2020 financial...
FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
October 09, 2020
Alkermes plc (Nasdaq: ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...
Trading in Alkermes Ordinary Shares Halted Today
October 09, 2020
-- FDA Advisory Committee to Review New Drug Application for ALKS 3831 for the Treatment of Adults with Schizophrenia or Bipolar I Disorder --
Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831
October 07, 2020
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oct. 9, 2020 joint meeting of the Psychopharmacologic...
Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress
September 18, 2020
- Data Provide Evidence of Clinical Benefit and Tolerability of ALKS 4230 as Monotherapy in Melanoma and in Combination With Pembrolizumab in Multiple Tumor Types -
-- New Outcomes Research Analyzed Patterns of Weight Gain and Treatment Interruptions Associated With the Use of Second-Generation Oral Antipsychotics in Patients With Schizophrenia or Bipolar I...
Alkermes to Take Part in Cantor Virtual Global Healthcare Conference
September 09, 2020
Alkermes plc (Nasdaq: ALKS) announced today that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday,...
Alkermes to Present New Data on Investigational Immuno-Oncology Candidate, ALKS 4230, at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress
September 08, 2020
Virtual FDA Advisory Committee Meeting to Review New Drug Application for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder Tentatively Scheduled for Oct. 9, 2020
August 21, 2020
Alkermes plc (Nasdaq: ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management...
Alkermes Initiates Phase 2 Study Designed to Evaluate Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Patients with Advanced Solid Tumors
August 19, 2020
Alkermes plc (Nasdaq: ALKS) today announced the initiation of ARTISTRY-3, a new phase 2 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy on the tumor microenvironment of...
American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia
August 17, 2020
Alkermes plc (Nasdaq: ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American...
Alkermes plc Reports Second Quarter 2020 Financial Results and Issues 2020 Financial Expectations
July 29, 2020
-- Company Reports Second Quarter Revenues of $247.5 Million, GAAP Net Loss per Share of $0.19 and Diluted Non-GAAP Earnings per Share of $0.06 --
New Harris Poll Survey Offers Insights into Potential of Telepsychiatry During and After the COVID-19 Pandemic
July 27, 2020
A Majority of Respondents Managing Mental Health Conditions Welcome Telepsychiatry Option to Support Continuity of, and Access to, Mental Health Care
Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020 to discuss the company's second quarter 2020 financial...
Alkermes Awards COVID-19 Relief Fund Grants to 10 Innovative Programs Designed to Address Challenges for Patient Communities
June 24, 2020
- Special Edition of Alkermes Inspiration Grants® Program Focused on Addressing Pandemic-Related Needs of People Living with Addiction, Serious Mental Illness, or Cancer -
New Preclinical Data on ALKS 4230 in Combination With Lucitanib to be Presented at 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II
June 22, 2020
- Combination Therapy Resulted in Durable, Dose-Dependent Antitumor Efficacy in a Preclinical Model of Colon Cancer -
Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference on Thursday, June 11, 2020 at 9:40 a.m. ET...
Alkermes Highlights New Data From Schizophrenia Portfolio at the American Society of Clinical Psychopharmacology 2020 Annual Meeting
May 27, 2020
-- Findings From Qualitative Patient Substudy Evaluating Health-Related Quality of Life in Patients With Schizophrenia and Treatment Satisfaction, Including Treatment with ALKS 3831, to be Presented...
Journal of Clinical Psychiatry Publishes Data from Alkermes' ALPINE Study in Patients With Schizophrenia
May 20, 2020
-- Phase 3b Study Evaluated Efficacy and Safety of ARISTADA® 2-month Dose, Together With ARISTADA INITIO® One-day Initiation Regimen, in Patients Hospitalized for Acute Schizophrenia --
Alkermes Presents New Data From Schizophrenia Portfolio at Virtual 2020 Congress of the Schizophrenia International Research Society
May 14, 2020
-- E-Poster Presentations Include Results From Completed 52-Week, Open-Label Safety Study of ALKS 3831 in Patients With Schizophrenia --