Sage Therapeutics (SAGE:US) shares fell as much as 50% on Monday after the company’s treatment for postpartum depression in adults developed together with Biogen (BIIB:US) received only partial approval by the United States Food and Drug Administration (FDA).
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
While the Zurzuvae (zuranolone) medication is approved, the medicine was rejected for the treatment of major depressive disorder (MDD). This has been a major discussion point amongst analysts as the general approval for Zurzuvae was already priced into the SAGE stock.
“The CRL [FDA’s Complete Response Letter] stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage and Biogen are reviewing the feedback and evaluating next steps,” the two companies said in a statement.
Sage’s CEO Barry Greene added he is “highly disappointed” by the FDA’s decision. In response to the ruling, several Wall Street analysts downgraded their rating on SAGE stock.