Sage Therapeutics shares are trading lower after the company announced the FDA issued a Complete Response Letter for the New Drug Application for zuranolone in the treatment of adults with major depressive disorder.
Portfolio Pulse from Benzinga Newsdesk
Sage Therapeutics has received a Complete Response Letter from the FDA regarding its New Drug Application for zuranolone, a treatment for adults with major depressive disorder. This has led to a decrease in the company's share price.
August 07, 2023 | 12:35 pm
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NEGATIVE IMPACT
Sage Therapeutics' stock price is expected to be negatively impacted in the short term due to the FDA's Complete Response Letter regarding its new drug zuranolone.
The FDA's Complete Response Letter is typically a form of rejection, indicating that the agency will not approve the drug in its current form. This is a significant setback for Sage Therapeutics, as the approval of zuranolone would have potentially led to increased revenues. As a result, the company's stock price is expected to decrease in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100