Why Sage Therapeutics Shares Are Sinking Monday
Portfolio Pulse from Adam Eckert
Sage Therapeutics shares are trading lower after the FDA issued a Complete Response Letter (CRL) for its New Drug Application for zuranolone for treatment of adults with major depressive disorder. The FDA stated that additional studies will be needed as the application didn't provide substantial evidence of effectiveness. The company's shares were down 49.4% at $18.26.

August 07, 2023 | 2:30 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 response to its new drug application.
The FDA's response indicates that the company's new drug application for zuranolone didn't provide substantial evidence of effectiveness. This is a significant setback for the company, which is likely to negatively impact its stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100