Sage Therapeutics Inc.’s Stock Plummets on FDA Decision

by Warren Seah

Sage Therapeutics Inc.’s stock (SAGE, +0.25%) experienced a significant drop of 49% in premarket trading on Monday, following the disappointing news that the U.S. regulator has approved its zuranolone treatment solely for postpartum depression and not for major depressive disorder (MDD), a much broader condition.

Zuranolone – A Breakthrough Treatment for Postpartum Depression

The Food and Drug Administration (FDA) granted approval for zuranolone, a treatment co-developed with Biogen Inc., making it the first and only oral option available for postpartum depression. According to CDC data, this condition affects one in eight new mothers in the U.S. Previously, the only available treatment involved an intravenous injection that necessitated a hospital stay of two-and-a-half days.

Sage’s Response and Future Plans

Sage Therapeutics responded to the FDA’s decision by stating that they are carefully reviewing the feedback received and assessing their next steps. As CEO Barry Greene explained, “While we believe we are well capitalized, given the impact of the complete response letter (CRL) for zuranolone in MDD on our plans, we are currently evaluating resource allocation, including pipeline prioritization and a workforce reorganization with a goal of extending our cash runway.” Greene further emphasized that with the right-sized organization and portfolio, Sage has the potential to emerge as an even stronger company. The company intends to share more detailed information and next steps before the end of the third quarter.

Impact on Biogen’s Stock

Biogen’s stock (BIIB, +0.44%) also experienced a premarket decline of 1.9% following these developments.

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