Sage Therapeutics, Biogen Start Rolling Submission For Zuranolone In Major Depressive Disorder

Sage Therapeutics Inc SAGE and Biogen Inc BIIB have initiated a rolling submission of a marketing application to the FDA for zuranolone in major depressive disorder (MDD).
Zuranolone is an investigational two-week, once-daily oral drug developed for MDD and postpartum depression (PPD).
The companies have submitted the nonclinical module and plan to submit the remaining components for the MDD filing in 2H of 2022.
Related: Sage Therapeutics - Biogen Partnered Depression Drug Meets Main Goal In Late-stage Study.
Data from the completed studies of zuranolone in the LANDSCAPE and NEST programs, including data from the ongoing open-label SHORELINE Study in MDD and data from the completed clinical pharmacology studies, will comprise the full submission package.
The rolling submission process allows completed sections of an application to be submitted to the FDA for review on an ongoing basis.
Sage and Biogen plan to submit an associated application submission for PPD in the first half of 2023.
Price Action: SAGE shares are up 0.57% at $31.70, and BIIB stock is down 0.90% at $205.57 during the market session on the last check Monday.