Sage Therapeutics downgraded to Hold at Canaccord after Zurzuvae CRL

As previously reported, Canaccord analyst Sumant Kulkarni downgraded Sage Therapeutics to Hold from Buy with a price target of $21, down from $64, after the FDA approved Zurzuvae for post-partum depression, or PPD, but issued a Complete Response Letter in the “much larger market opportunity” of major depressive disorder, or MDD. Management was not in a position to provide too many details on a path forward in MDD “fresh from this unfortunate outcome,” other than discussing the CRL with the FDA using conventional channels and that it disagrees with the decision, the analyst tells investors. Ex-zuranolone clinical trial data-related catalysts are “some time off” and there is uncertainty created by this outcome on MDD, the analyst argues.