Sage, Biogen: Zuranolone Hits Key Goals in Postpartum Depression
June 01 2022 - 6:21AM
Dow Jones News
By Colin Kellaher
Sage Therapeutics Inc. and Biogen Inc. on Wednesday said a Phase
3 study of their antidepressant drug candidate zuranolone in women
with postpartum depression met its main endpoints.
The companies said zuranolone showed a statistically significant
and clinically meaningful improvement in depressive symptoms at day
15, the primary endpoint, and at the key secondary endpoints of
days 3, 28 and 45.
Sage and Biogen also said zuranolone was generally
well-tolerated and showed a safety profile consistent with prior
studies
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 last month said they had initiated a rolling
submission of a new-drug application with the U.S. Food and Drug
Administration for zuranolone in the treatment of major depressive
disorder and plan to complete the filing in the second half of the
year.
Sage and Biogen said they plan an associated filing for
postpartum depression early next year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 01, 2022 07:06 ET (11:06 GMT)
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