Sage plummets 46% after FDA declines zuranolone in major depression
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An FDA Complete Response Letter issued Aug. 4 to Sage Therapeutics for its drug zuranolone (NASDAQ:SAGE) as a major depressive disorder (MDD) treatment is leading the company to consider a workforce reorganization and pipeline prioritization plan.
The stock is down ~46% in premarket trading Monday. Biogen (BIIB), its partner on zuranolone, is down ~3%.

CEO Barry Greene said the moves would help to extend the biopharma's cash runway. He added that further details would be provided by the end of the quarter.
Although the FDA on Aug. 4 approved zuranolone under the brand name Zurzuvae for postpartum depression, it declined to do so for MDD, a much larger market for the drug, citing lack of efficacy. The agency is asking for an additional study or studies for that indication.

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