Alkermes plc

NASDAQ:ALKS   3:59:57 PM EDT
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Alkermes Receives FDA Complete Response Letter Related To ALKS 3831 Manufacturing Records Review

Published: 11/17/2020 12:33 GMT
Alkermes Plc (ALKS) - Alkermes Receives FDA Complete Response Letter Related to Alks 3831 Manufacturing Records Review.
Alkermes Plc - No Clinical Efficacy Or Safety Issues Raised and No Further Studies Required by FDA to Support Approval.
Alkermes Plc -.
Alkermes Plc - Plans to Engage With FDA Toward Expeditious Resolution of Outstanding Items.
Alkermes - Throughout Development, Alks 3831 Demonstrated Consistent Antipsychotic Efficacy, Safety, Tolerability Profile in Schizophrenia Patients.
Alkermes - FDA Stated Resolution of Certain Conditions for Tablet Coating Process at Wilmington, Oh Facility Required Before Alks 3831 May Be Approved.