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Sage Therapeutics to implement accelerated development plan for antidepressant SAGE-217

Published 06/12/2018, 07:18 AM
© Reuters.  Sage Therapeutics to implement accelerated development plan for antidepressant SAGE-217
SAGE
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  • Based on a Breakthrough Therapy meeting with the FDA, Sage Therapeutics (NASDAQ:SAGE) will pursue an accelerated development plan for GABA modulator SAGE-217 for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
  • A single additional Phase 3 study in MDD and the ongoing Phase 2 study in PPD will serve as pivotal trials supporting a U.S. marketing application. An open-label study will assess the potential of episodic treatment for recurrent or new major depressive episodes and provide additional safety data.
  • The Phase 3 MDD study will launch in H2. Topline results from the Phase 2 PPD trial should be available in Q4.
  • Management will host a conference call this morning at 8:00 am ET to discuss the plan.
  • Now read: Nektar Therapeutics: In The Midst Of A Difficulty An Opportunity Arises


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