- Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ: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.
