ARTICLE | Company News
Sage's postpartum depression candidate gets Priority Review
May 30, 2018 4:24 PM UTC
Sage Therapeutics Inc. (NASDAQ:SAGE) said FDA accepted and granted Priority Review to an NDA for brexanolone (SAGE-547) to treat postpartum depression (PPD). Its PDUFA date is Dec. 19.
In November, the therapy met the primary endpoints in two Phase III trials to treat PPD. Brexanolone is a positive allosteric modulator (PAM) of GABA A receptor (see BioCentury Extra, Nov. 9, 2017)...
BCIQ Company Profiles
BCIQ Target Profiles