SAGE - Biogen Sage to submit a single marketing application for depression candidate

Commercial-stage biotech Sage Therapeutics (NASDAQ:SAGE) announced on Monday that the company will submit a single new drug application (NDA) to the FDA for zuranolone, a candidate the company developed with Biogen (BIIB) for two forms of depression. In April, the partners began the rolling submission of an NDA for zuranolone as a treatment for major depressive disorder (MDD). Previously, Sage (SAGE) announced it would complete the NDA submission in H2 2022 for MDD and plan to seek a separate NDA filing for the approval of zuranolone in postpartum depression (“PPD”) in early 2023 subject to completion of a late-stage trial. Instead of two filings, Sage (SAGE) and Biogen (BIIB) has decided to file a single NDA for approval of zuranolone as a treatment for both MDD and PPD. “The Company has informed the FDA of this update, and the FDA raised no objections and stated it looked forward to continuing

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Biogen, Sage to submit a single marketing application for depression candidate