FDA grants Priority Review to depression drug; Sage’s stock rallies

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FDA grants Priority Review to depression drug; Sage’s stock rallies
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Shares of Sage Therapeutics Inc. gained about 5% in premarket trading on Monday after the company said the experimental treatment for major depressive...

Shares of Sage Therapeutics Inc. SAGE gained about 5% in premarket trading on Monday after the company said the experimental treatment for major depressive disorder and postpartum depression that it’s developing with Biogen Inc. BIIB received Priority Review. The Food and Drug Administration is now set to make a decision whether to approve zuranolone by Aug. 5. RBC Capital Markets analyst Brian Abrahams told investors he expects an FDA approval, with a “solid $1.3B [worldwide] sales opportunity.

... Shares of Sage Therapeutics Inc. SAGE gained about 5% in premarket trading on Monday after the company said the experimental treatment for major depressive disorder and postpartum depression that it’s developing with Biogen Inc. BIIB received Priority Review. The Food and Drug Administration is now set to make a decision whether to approve zuranolone by Aug. 5. RBC Capital Markets analyst Brian Abrahams told investors he expects an FDA approval, with a “solid $1.

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