Sage Therapeutics/Biogen Highlight Additional Data From Depression Candidate

Sage Therapeutics Inc SAGE and Biogen Inc BIIB presented additional data from the Phase 3 SKYLARK Study of zuranolone in adult women with postpartum depression (PPD).
The SKYLARK Study, as previously reported, achieved the primary and all key secondary endpoints.
Zuranolone 50 mg showed a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to the placebo.
In the presentation at the European College of Neuropsychopharmacology Congress, additional secondary endpoint data demonstrated that a higher proportion of patients in the zuranolone 50 mg arm achieved a HAMD-17 response compared with the placebo arm.
Data also showed that a higher proportion of patients in the zuranolone arm achieved HAMD-17 remission than in the placebo arm.
Zuranolone was generally well-tolerated, with a safety profile consistent with that observed in the clinical development program.
Sage Therapeutics and Biogen have initiated a rolling submission to the FDA and plan to complete the filing in 2H of 2022.
Price Action: SAGE shares are down 0.03% at $37.92, and BIIB stock is up 1.05% at $267.40 on the last check Monday.