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BioWorld - Saturday, February 21, 2026
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Home » Sage’s Zurzuvae approval and CRL roil the company and its stock
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Sage’s Zurzuvae approval and CRL roil the company and its stock

Aug. 7, 2023
By Lee Landenberger
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
BioWorld Regulatory Neurology/psychiatric U.S. FDA

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