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FDA accepts Alkermes' marketing application for ALKS 5461 for MDD, action date January 31, 2019; shares ahead 21% premarket

Published 04/16/2018, 07:36 AM
© Reuters.  FDA accepts Alkermes' marketing application for ALKS 5461 for MDD, action date January 31, 2019; shares ahead 21% premarket
ALKS
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  • Alkermes (NASDAQ:ALKS) is up 21% premarket on light volume in response to its announcement that the FDA has accepted for review its marketing application seeking approval for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). The agency initially refused to accept the application citing inadequate data to demonstrate effectiveness.
  • The action date (PDUFA) is January 31, 2019.
  • Fast Track-tagged ALKS-5461 is a once-daily, orally administered formulation of samidorphan and buprenorphine that is designed to rebalance brain function that is dysregulated in the state of depression.
  • Previously: FDA rejects Alkermes' marketing application for MDD med ALKS 5461 (April 2)
  • Now read: Alkermes Receives Refusal To File Letter From The FDA, Is There Any Hope?


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