Sage Therapeutics/Biogen Highlight Additional Data From Depression Candidate

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

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