: Sage Therapeutics’ stock craters 49% after FDA approves zuranolone for postpartum depression, but not major depressive disorder

Sage Therapeutics Inc.’s stock SAGE cratered 49% in premarket trade Monday, on disappointment that the U.S. regulator approved its zuranolone treatment for postpartum depression, but not for major depressive disorder, or MDD, which is a far broader condition. The Food and Drug Administration approved the treatment which was co-developed with Biogen Inc. in an announcement late Friday, making it the first-and-only oral treatment for post-partum, which affects one in eight new mothers in the U.S., according to CDC data. Until now, the only available option for this condition has been an intravenous injection that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days. On Monday, Sage said its’s reviewing the feedback from the FDA and evaluating its next steps. “While we believe we are well capitalized, given the impact of the CRL (complete response letter) 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,” CEO Barry Greene said in a statement. “With a right-sized organization and portfolio, we believe we have an opportunity to emerge as an even stronger company. We plan to provide greater detail and next steps before the end of the third quarter.” Biogen’s stock BIIB was down 1.9% premarket.

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