Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ:BIIB) have announced 12-month data for the cohort of patients (n=199) who received zuranolone 50 mg once for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study.

• Related: Sage Therapeutics - Biogen's Zuranolone Tops Placebo In Reducing Depressive Symptoms.
• The data showed that zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received. 
• Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms in MDD patients.
• In the zuranolone 50 mg cohort, most patients who responded to an initial 14-day course received only one two-week course of treatment during the study, and nearly 80% received only one or two treatment courses in total.
• Zuranolone 50 mg was generally well-tolerated with an overall adverse event profile consistent with earlier data, and 6.5% of patients discontinued the study drug due to adverse events.
• The companies plan to submit an FDA marketing application in 2H of 2022. The planned initial submission package will seek approval of zuranolone for major depressive disorder (MDD), and an additional filing for postpartum depression (PPD) is anticipated in the 1H of 2023. 
• Also See: Sage Therapeutics Drops Two Zuranolone Depression Trials Deemed Unnecessary For Approval.
• Price Action: BIIB shares closed 0.15% lower at $235.74 on Tuesday, and SAGE stock is up 0.75% at $39.2 during the premarket session on Wednesday's last check.