FDA Breakthrough designation for SAGE-547 for postpartum depression

The US Food and Drug Administration has granted Breakthrough Therapy designation to SAGE-547 for the treatment of postpartum depression (PPD) from US clinical-stage biotech Sage Therapeutics (Nasdaq: SAGE).

The news pushed the firm’s shares 12.2% higher to $40.92 yesterday.

“Postpartum depression can be a devastating mental health disorder that negatively impacts all members of a family and for which there are no approved therapies. Breakthrough Therapy Designation from the FDA reflects the urgent need for treatment options for women suffering with this condition,” said Jeff Jonas, chief executive of Sage, adding: “Sage recently reported encouraging top-line results from our placebo-controlled Phase II trial in women with severe PPD in which SAGE-547 achieved a significant, rapid and durable reduction in depression scores compared with placebo. We look forward to working with the FDA to expedite the development of SAGE-547 in this indication.”