Sage Therapeutics (SAGE) and Biogen (BIIB) announced the completion of the rolling submission of a New Drug Application to the U.S. FDA for zuranolone in the treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, 14-day oral short course treatment in adults with MDD and PPD. The submission completes the NDA filing that was initiated earlier this year.
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