Sage and Biogen plan for zuranolone NDA filing

Following recent discussions with the US regulator, Sage Therapeutics (Nasdaq: SAGE) and partner Biogen (Nasdaq: BIIB) said yesterday they plan to submit a New Drug Application (NDA) to the US Food and Drug Administration for zuranolone (SAGE-217), an investigational two-week, once-daily therapeutic, in the second half of 2022.

The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.

Sage’s shares closed down 8.6% at $40.29 yesterday following the announcement.