Sage shares surge 4.5% on plan to expedite drug development for two types of depression
Sage Therapeutics Inc. shares surged 4.5% in premarket trade Tuesday on news that the company met with the Food and Drug Administration and now plans to expedite development of its SAGE-217 drug in two areas of depression, major depressive disorder and postpartum depression. Sage plans one new phase 3 trial in major depressive disorder, which will likely begin in the second half of this year, to support a FDA filing for the indication. It also plans to use an ongoing trial for postpartum depression, for which early results are expected in the fourth quarter, to support another filing. The two trials will look at a short course treatment of the drug, termed “episodic dosing,” and how that works to reduce symptoms of depression as compared with a placebo. The faster-than-usual development plan was made possible by a phase 2 trial of SAGE-217 in major depressive disorder, for which Sage released positive results in December. More data about the drug will be gathered through a long-term, open-label study that will follow about 300 patients for six months, and about 100 patients for a year, the company said. SAGE-217 got “breakthrough therapy” designation from the FDA in February, which allows for an expedited development path. Sage shares have dropped 17.8% over the last three months, compared with a 0.04% decline in the S&P 500 and a 0.6% rise in the Dow Jones Industrial Average .
Source : MTV
