Alkermes (ALKS) PT Lowered to $45 at Cantor Fitzgerald
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Alkermes Receives Refusal to File Letter From FDA for ALKS 5461
April 2, 2018 7:00 AM EDTDUBLIN, April 2, 2018 /PRNewswire/ --Â Alkermes plc (Nasdaq: ALKS) today announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.
Upon its preliminary review, the FDA has taken the position that it... More
