Alkermes
852 Winter Street
Waltham
Massachusetts
02451
United States
Tel: 781-609-6000
Website: http://www.alkermes.com/
Email: mediainfo@alkermes.com
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com .
Key Executives:
Richard F. Pops- Chairman and Chief Executive Officer
Shane Cooke- President
Kathryn L. Biberstein- Executive Vice President, Chief Compliance Officer and Chief Administrative Officer, and Secretary Alkermes plc
Iain Brown- Senior Vice President, Finance and Chief Accounting Officer
Madeline D. Coffin- Senior Vice President, Human Resources
Elliot W. Ehrich, M.D.- Executive Vice President, Research and Development
James M. Frates- Senior Vice President, Chief Financial Officer
David J Gaffin- Senior Vice President, Chief Legal Officer
Georgianna Harris, Ph.D.- Senior Vice President, Regulatory Affairs
Craig Hopkinson, M.D.- Chief Medical Officer, and Senior Vice President of Clinical Development and Medical Affairs
Blair C. Jackson- Senior Vice President, Business Development
Michael J. Landine- Senior Vice President, Corporate Development
Mark Namchuk, Ph.D.- Senior Vice President, Research, Pharmaceutical and Nonclinical Development
Peter Norman- Vice President, Government Affairs and Policy
Declan O’Connor- Senior Vice President, Operations
Phil Shanahan, Ph.D.- Vice President, Quality Operations
Mark P. Stejbach- Senior Vice President, Chief Commercial Officer
Locations
Alkermes Corporate Headquarters
Connaught House
1 Burlington Road
Dublin 4, Ireland
+353 1 772 8000
Waltham, Massachusetts
852 Winter Street
Waltham, MA 02451
+1 781 609 6000
Athlone, Ireland
Monksland, Athlone
Co Westmeath, Ireland
+353 90 649 5000
Gainesville, Georgia
1300 Gould Drive
Gainesville, GA 30504
+1 770 531 8100
Wilmington, Ohio
265 Olinger Circle
Wilmington, OH 45177
+1 937 382 5642
676 articles about Alkermes
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Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma
3/11/2021
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 immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).
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Alkermes to Hold Virtual Investor Day
3/4/2021
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 ).
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Alkermes to Take Part in SVB Leerink 10th Annual Global Healthcare Conference
2/18/2021
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 p.m. GMT ).
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Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2020 and Provides Financial Expectations for 2021
2/11/2021
-- 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 -- -- Financial Expectations for 2021 Reflect Anticipated Growth of Proprietary Products and Investment in Strategic Priorities for Long-Term Value Creation --
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Alkermes to Host Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results
2/4/2021
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 financial results. Management will also discuss financial expectations for 2021 and provide an update on the company.
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Alkermes to Present at the 39th Annual J.P. Morgan Healthcare Conference
1/6/2021
Alkermes plc (Nasdaq: ALKS) announced today that its Chief Executive Officer, Richard Pops , will provide a corporate overview and update at the 39 th Annual J.P. Morgan Healthcare Conference. The presentation will take place virtually on Wednesday, Jan. 13, 2021 at 10:00 a.m. EST ( 3:00 p.m. GMT ), followed by a question and answ
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Alkermes Announces Updates to Executive Leadership Team
1/6/2021
Blair C. Jackson Appointed Chief Operating Officer and Iain M. Brown Named Chief Financial Officer, Positioning Company for Continued Strong Execution of Business Strategy
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FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
12/29/2020
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophr
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Alkermes Announces Strategic Value Enhancement Plan and Continued Board Refreshment
12/10/2020
- 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 - - Announces Potential Monetization of Non-Core Assets and Reiterates Commitment to Exploring Strategic Collaborations Around ALKS 4230 - - Two New Independent Directors Appointed and Board Refreshment Program to Continue -
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Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review
11/17/2020
-- No Clinical Efficacy or Safety Issues Raised and No Further Studies Required by FDA to Support Approval -- -- Company Plans to Engage With FDA Toward Expeditious Resolution of Outstanding Items -- -- Investor Conference Call Scheduled for Today at 8:00 a.m. ET --
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The two companies received Complete Response Letters from the FDA this week, along with Sanofi.
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Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting
11/9/2020
New Data From ARTISTRY-1 Trial Provide Additional Evidence of Therapeutic Potential of ALKS 4230 as Monotherapy and in Combination With Pembrolizumab in Multiple Tumor Types
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Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.
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Alkermes Reschedules Third Quarter 2020 Financial Results Conference Call to 10:30 a.m. ET
10/29/2020
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 provider. The company now plans to host the conference call and webcast presentation at 10:30 a.m. ET ( 2:30 p.m. GMT ) on Thursday, Oct. 29
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Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations
10/29/2020
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
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Shares of Alkermes were up more than 12% in pre-market trading after the Ireland-based company announced late Friday that its schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
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FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
10/9/2020
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 Committee, appointed by the U.S. Food and Drug Administration (FDA). The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an inves
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The assessment does point to a path for approval, however FDA staff do raise some concerns about the fact that the drug’s makeup includes an opioid antagonist.
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Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831
10/7/2020
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 Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company's New Drug Application (NDA) f
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Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress
9/18/2020
Data Provide Evidence of Clinical Benefit and Tolerability of ALKS 4230 as Monotherapy in Melanoma and in Combination With Pembrolizumab in Multiple Tumor Types