Robbins Geller Rudman & Dowd LLP is investigating potential violations of U.S. federal securities laws involving Sage Therapeutics, Inc. (NASDAQ: SAGE) focused on whether Sage Therapeutics and certain of its top executives made false and/or misleading statements and/or failed to disclose material information to investors.
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THE COMPANY: Sage Therapeutics is a biopharmaceutical company that develops and commercializes brain health medicines. On December 6, 2022, Sage Therapeutics and Biogen Inc. announced the completion of the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for zuranolone in the treatment of major depressive disorder (“MDD”) and postpartum depression (“PPD”). 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 REVELATION: On August 4, 2023, Sage Therapeutics disclosed that “the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed.” Following this news, the price of Sage Therapeutics stock declined by more than 43%.
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