Sage Therapeutics ($SAGE) announced top line data from its Phase 2 clinical trial of orally-administered SAGE-217 for the treatment of major depressive disorder. The primary endpoint of the 13 patient Part A open-label trial was to evaluate safety and tolerability. SAGE-217 was found to be generally well-tolerated with no serious adverse events or discontinuations reported. The reduction from baseline in depression ratings seen in Part A of the trial met the company's criteria for advancing SAGE-217 into a planned double-blind, placebo-controlled study (Part B).
The company is also working on its another drug candidate SAGE-547, which is being developed for treating postpartum depression. Recently it announced an expedited development plan for the drug after a formal meeting with the U.S. Food and Drug Administration. Sage is looking to file for approval in 2018. The topline data from postpartum depression registration trials is expected to be due in the second half of this year. The drug candidate was classified as a breakthrough therapy with the FDA in September last year.
The stock is up nearly 48 percent in the past 12 months. However, it lost close to 7 percent of its value this year so far. The stock price is expected to perk following positive news from the company.