Shares of Sage Therapeutics Inc. gained 0.5% in premarket trading on Wednesday, the day after the company said it and Biogen Inc. plan to submit their experimental depression drug to U.S. regulators for approval in the second half of next year. They will also seek approval for zuranolone as a treatment for postpartum depression in the first half of 2023. “The good news is that Biogen (OP)/Sage (MP) have confirmation from the FDA that they have the necessary efficacy data to file for major depressive disorder,” SVB Leerink’s Marc Goodman told investors on Wednesday. “Investors were expecting a filing in both MDD and PPD around the end of the year, so this is a notable filing delay.” Sage’s stock is down 53.4% this year, while the broader S&P 500 is up 20.3%.
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