Sage Therapeutics +12% premarket on development plan for zuranolone

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.

https://seekingalpha.com/news/3552848-sage-therapeuticsplus-12-premarket-on-development-plan-for-zuranolone