Sage Therapeutics and Biogen announced positive and consistent results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder (MDD) and postpartum depression (PPD).
Sage Therapeutics ended two late-stage studies of the depression drug zuranolone after discussions with the U.S. Food and Drug Administration led the company to believe they were unnecessary for potential regulatory approval.
Sage Therapeutics shares were up after the company won approval for the postpartum depression treatment Zulresso (brexanalone).
Sage Therapeutics’ postpartum depression oral treatment met the main goal of reducing the condition’s symptoms versus a placebo in a late-stage study, sending the drugmaker’s shares up 33 percent.
Days after the U.S. Food and Drug Administration provided an expedited path forward for SAGE Therapeutics’ depression treatment SAGE-217, the company snagged a deal worth $575 million from Japanese pharma firm Shionogi & Co. Ltd. to market the potential drug in parts of Asia.
Following a meeting with the U.S. Food and Drug Administration, SAGE Therapeutics is seeing the goal line for potential expedited approval of the company’s major depressive disorder and postpartum depression treatment, SAGE-217.
Sage Therapeutics, located in Cambridge, Mass., submitted a New Drug Application to the U.S. Food and Drug Administration for brexanolone (SAGE-547) to treat postpartum depression.
Sage Therapeutics Inc.’s drug to treat patients with moderate to severe depression met the main goal in a mid-stage study.
Sage Therapeutics Inc.’s postpartum depression drug succeeded in two late-stage studies, paving the way for it to bring to market the first FDA-approved treatment for the disorder.
Sage Therapeutics Inc.’s shares tumbled 23 percent after its drug to treat a life-threatening seizure disorder failed to meet the main goal of a key trial.