News releases from Alkermes plc
Alkermes Announces Clinical Trial Collaboration and Supply Agreement With MSD to Evaluate Nemvaleukin Alfa in Combination With KEYTRUDA® in Patients With Platinum-Resistant Ovarian Cancer
April 07, 2021
Alkermes plc (Nasdaq: ALKS) today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned...
Alkermes to Take Part in Stifel's 3rd Annual CNS Day
March 25, 2021
Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a virtual fireside chat at Stifel's 3rd Annual CNS Day on Thursday, Apr. 1, 2021 at 8:30 a.m. ET (1:30 p.m. BST). The...
- Company Will Provide New Updates and Disclose New Programs in Neuroscience and Oncology Development Pipeline-
Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma
March 11, 2021
Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), the company's investigational engineered interleukin-2 (IL-2) variant...
Alkermes to Hold Virtual Investor Day
March 04, 2021
Alkermes plc (Nasdaq: ALKS) announced today that it will hold a virtual Investor Day on Thursday, March 25, 2021, beginning at 9:00 a.m. ET (1:00 p.m. GMT). During the event, members of Alkermes'...
Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on Wednesday, Feb. 24, 2021 at 9:20 a.m. ET (2:20...
Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2020 and Provides Financial Expectations for 2021
February 11, 2021
-- Revenues of $1.04 Billion in 2020, GAAP Loss per Share of $0.70 and Basic and Diluted Non-GAAP Earnings per Share of $0.43 --
Alkermes to Host Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results
February 04, 2021
Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 11, 2021 to discuss the company's fourth quarter and year-end 2020...
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 --