Sage Therapeutics (NASDAQ:SAGE) announces next steps in the Landscape Program, the clinical program evaluating zuranolone (SAGE-217) for the treatment of postpartum depression (PPD) and major depressive disorder (MDD), following a Breakthrough Therapy guidance meeting with the FDA.
Following discussions with the FDA, Sage plans to initiate three new short-term clinical studies in 2020, if successful, for three distinct indications: PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and episodic treatment of MDD. These planned studies include:
For use as an oral therapy in women with PPD; for use as an acute rapid response therapy (RRT) in patients with MDD when co-initiated with new standard antidepressant therapy and for use as an episodic therapy in patients with MDD.
Topline data from all the three studies evaluating a two-week course of zuranolone 50 mg is anticipated in 2021.
The Company is on track to report topline data from Shoreline Study (MDD-303) in 2020 from patients with MDD who received zuranolone 30 mg.
Sage has paused enrollment in the Redwood and Rainforest study in Q4 2019.
Shares are up 12% premarket.
Following discussions with the FDA, Sage plans to initiate three new short-term clinical studies in 2020, if successful, for three distinct indications: PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and episodic treatment of MDD. These planned studies include:
For use as an oral therapy in women with PPD; for use as an acute rapid response therapy (RRT) in patients with MDD when co-initiated with new standard antidepressant therapy and for use as an episodic therapy in patients with MDD.
Topline data from all the three studies evaluating a two-week course of zuranolone 50 mg is anticipated in 2021.
The Company is on track to report topline data from Shoreline Study (MDD-303) in 2020 from patients with MDD who received zuranolone 30 mg.
Sage has paused enrollment in the Redwood and Rainforest study in Q4 2019.
Shares are up 12% premarket.
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Disclaimer
The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.