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Oct. 20, 2021, 7:53 a.m. EDT

Sage, Biogen now plan to submit depression drug candidate to FDA in second half of 2022

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By Jaimy Lee

Shares of Sage Therapeutics Inc. /zigman2/quotes/200179567/composite SAGE +1.31% gained 0.5% in premarket trading on Wednesday, the day after the company said it and Biogen Inc. /zigman2/quotes/201531540/composite BIIB +3.48% 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 /zigman2/quotes/210599714/realtime SPX +0.31% is up 20.3%.

/zigman2/quotes/200179567/composite
US : U.S.: Nasdaq
$ 40.12
+0.52 +1.31%
Volume: 389,906
Dec. 8, 2021 4:00p
P/E Ratio
3.21
Dividend Yield
N/A
Market Cap
$2.33 billion
Rev. per Employee
$3.74M
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/zigman2/quotes/201531540/composite
US : U.S.: Nasdaq
$ 234.72
+7.89 +3.48%
Volume: 1.42M
Dec. 8, 2021 4:00p
P/E Ratio
22.96
Dividend Yield
N/A
Market Cap
$33.32 billion
Rev. per Employee
$1.36M
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/zigman2/quotes/210599714/realtime
US : S&P US
4,701.21
+14.46 +0.31%
Volume: 2.16B
Dec. 8, 2021 4:59p
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