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SAGE THERAPEUTICS, INC.

(SAGE)
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Sage Therapeutics, Biogen to Seek FDA Approval of Zuranolone in 2nd Half of 2022

10/19/2021 | 05:25am EST

By Colin Kellaher

Sage Therapeutics Inc. and Biogen Inc. on Tuesday said they plan to seek U.S. Food and Drug Administration approval for their antidepressant drug candidate zuranolone in the second half of 2022.

The companies said they plan to start a rolling submission early next year, and the initial package will seek approval of zuranolone for the treatment of major depressive disorder.

Sage and Biogen said the decision follows recent discussions with the FDA, noting that they expect the current efficacy and safety databases to be adequate for filing.

Sage and Biogen said they plan an additional filing for postpartum depression in the first half of 2023.

Sage and Biogen, both based in Cambridge, Mass., late last year signed a global collaboration and license agreement to jointly develop and commercialize zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders.

The companies in June said a Phase 3 study of the drug in major depressive disorder met its primary endpoint, showing statistically significant improvement in symptoms compared with placebo.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

10-19-21 0725ET

Stocks mentioned in the article
ChangeLast1st jan.
BIOGEN INC. -2.01% 223.92 Delayed Quote.-6.27%
SAGE THERAPEUTICS, INC. -3.41% 37.06 Delayed Quote.-57.16%
All news about SAGE THERAPEUTICS, INC.
12/01Sage Therapeutics, Biogen Report Positive Data From Antidepressant Drug Candidate Zuran..
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12/01SAGE THERAPEUTICS : and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the On..
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12/01SAGE THERAPEUTICS, INC. : Other Events, Financial Statements and Exhibits (form 8-K)
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11/29Sage Therapeutics to Host Sage FutureCast Webcast
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11/24Sage Therapeutics to Present at the Piper Sandler 33rd Annual Virtual Healthcare Confer..
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11/18Mizuho Securities Adjusts Price Target on Sage Therapeutics to $44 From $52, Maintains ..
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11/11Sage Therapeutics to Present at the Stifel 2021 Virtual Healthcare Conference
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11/03Oppenheimer Cuts PT on Sage Therapeutics to $80 from $84; Outperform Rating Maintained
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11/03RBC Cuts Price Target on Sage Therapeutics to $48 From $52, Maintains Sector Perform, S..
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11/03HC Wainwright Adjusts Sage Therapeutics' Price Target to $55 From $80, Maintains Neutra..
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Analyst Recommendations on SAGE THERAPEUTICS, INC.
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Financials (USD)
Sales 2021 6,67 M - -
Net income 2021 -458 M - -
Net cash 2021 1 433 M - -
P/E ratio 2021 -4,75x
Yield 2021 -
Capitalization 2 183 M 2 183 M -
EV / Sales 2021 112x
EV / Sales 2022 16,3x
Nbr of Employees 298
Free-Float 87,6%
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Technical analysis trends SAGE THERAPEUTICS, INC.
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Mean consensus OUTPERFORM
Number of Analysts 22
Last Close Price 37,06 $
Average target price 73,24 $
Spread / Average Target 97,6%
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Managers and Directors
Barry E. Greene President, Chief Executive Officer & Director
Kimi E. Iguchi Chief Financial Officer & Treasurer
Kevin Paul Starr Chairman
Albert J. Robichaud Chief Scientific Officer
Amy Schacterle Senior VP-Research & Development Strategy
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