SAGE - Oppenheimer cuts Sage Therapeutics to perform cites FDA setback
2023-08-07 16:41:43 ET
Oppenheimer has cut its rating for Sage Therapeutics ( NASDAQ: SAGE ) to perform in the wake of news that the FDA has declined to approve its drug zuranolone for the treatment of major depressive disorder.
The investment bank said that it had been "incorrectly confident" that the FDA's decision not to hold an advisory committee meeting for the drug for MDD was a "positive signal" that the drug's efficacy was "not debatable." Instead, the bank said, the opposite was true.
Oppenheimer said it now believes that FDA's issuance of a Complete Response Letter for the drug without an advisory committee meeting as "convincing evidence that zuronolone will never be approved for MDD."
The bank said it was lowering its price target for Sage to $24.
More on Sage Therapeutics:
Sage Therapeutics, Inc. SAGE Business Update Call Transcript
Sage plummets 46% after FDA declines zuranolone in major depression
Sage Therapeutics GAAP EPS of -$2.68 misses by $0.11, revenue of $2.47M misses by $0.44M
Sage, Biogen zuranolone OKd for postpartum, but not major, depression
Sage Therapeutics' Zuranolone Is A Lost Cause In Depression Market
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Oppenheimer cuts Sage Therapeutics to perform, cites FDA setback