Sage Therapeutics Inc SAGE shares are trading lower Monday after the company announced the FDA issued a Complete Response Letter (CRL) for one of the company's New Drug Applications.
What To Know: Sage Therapeutics said the FDA approved ZURZUVAE (zuranolone) 50 mg for adults with postpartum depression, but issued a CRL for its NDA for zuranolone for treatment of adults with major depressive disorder.
The letter said Sage's application didn't provide substantial evidence of effectiveness to support the approval of zuranolone as a major depressive disorder treatment. The FDA determined that additional studies will be needed.
"In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief," said Barry Greene, CEO of Sage Therapeutics.
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SAGE Price Action: Sage shares were down 49.4% at $18.26 at the time of publication, according to Benzinga Pro.
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