Alkermes Announces Updates to Executive Leadership Team
Company for Continued Strong Execution of Business Strategy
Newly Appointed COO and CFO Will Oversee Implementation of Recently Announced Value Enhancement Plan
DUBLIN, Jan. 6, 2021 /PRNewswire/ Alkermes plc (Nasdaq: ALKS), a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology, today announced a series of changes to its executive leadership team. Blair C. Jackson has been appointed chief operating officer (COO) and Iain M. Brown will assume the role of chief financial officer (CFO), replacing James M. Frates. Mr. Frates will leave the company following a 20-year career at Alkermes to pursue another opportunity.
FDA Accepts Alkermes Resubmission of New Drug Application for ALKS 3831
- FDA Sets PDUFA Target Action Date of June 1, 2021 -
DUBLIN, Dec. 29, 2020 /PRNewswire/ 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 schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.
The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FDCA ) relating to the manufacture of ALKS 3831 at the company s Wilmington, OH facility. Subsequent to Alkermes resubmission of the NDA, the FDA issued a new request
Alkermes Announces Strategic Value Enhancement Plan and Continued Board Refreshment
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 -
- Alkermes to Host Investor Day in the First Quarter of 2021 to Update Investors on Plan Implementation and R&D Portfolio -
DUBLIN, Dec. 10, 2020 /PRNewswire/ Alkermes plc (Nasdaq: ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year pro