Shares of Alkermes plc ALKSjumped about 4.5% when the FDA accepted for review the new drug application (NDA) for ALKS 5461 for the treatment of major depressive disorder (“MDD”). The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate stating that the NDA did not have enough evidence for the oral medication to work.
Alkermes Rallies as FDA Accepts NDA for Depression Drug
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