Sage Therapeutics: FDA To Review NDA For Zuranolone - Quick Facts

Sage Therapeutics, Inc. (SAGE) and Biogen Inc. (BIIB) announced the FDA has accepted the filing of a New Drug Application for zuranolone in the treatment of major depressive disorder and postpartum depression. The application has been granted priority review and the FDA has assigned a PDUFA action date of August 5, 2023.

Priya Singhal, Executive Vice President, Head of Development and Interim Head of Research and Global Safety and Regulatory Sciences at Biogen, said: "The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression."

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