Sage Therapeutics has revealed a radical restructuring effort to cut costs and “enable the company to advance its corporate strategy and pipeline”. To this end, the company confirmed it would be axing 53% of its workforce, equivalent to 340 employees.
Four months after the critical failure of a closely-watched Phase III study, Sage Therapeutics is bringing out the ax to execute a major restructuring.
Sales of Sage Therapeutics' new postpartum depression drug Zulresso totaled just $1.5 million in the therapy's first full quarter since winning U.S. approval, confirming expectations that building a market would take time.
Postpartum depression is complex—and so is the first FDA-approved treatment. The 60-hour inpatient infusion process for Sage Therapeutic’s Zulresso calls for more-than-typical information and education, so along with identifying appropriate healthcare facilities, Sage has created a national support center to help patients through the process.
The treatment, developed by Sage Therapeutics, is administered via continuous IV infusion for 60 hours.
FDA approves first treatment for postpartum depression
Approximately 1 in 9 women in the United States experiences symptoms of postpartum depression, according to the Centers for Disease Control and Prevention (link is external). Now, the U. S. Food and Drug Administration (FDA) has approved brexanolone (link is external), an analog of the endogenous human hormone allopregnanolone and the first drug specifically designed to treat postpartum depression.
In just under three weeks, Sage Therapeutics should hear back from the FDA on its filing for new antidepressant Zulresso, and the company has just raised $575m to help the commercial rollout if approved.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the New Drug Application (NDA) for ZULRESSO™ (brexanolone) injection for the treatment of postpartum depression (PPD). The previously disclosed December 19, 2018 PDUFA goal date has been extended by a period of three months to March 19, 2019.