Cambridge, MA-based Sage Therapeutics, Inc. is a commercial-stage biopharmaceutical company focusing on life-changing brain health medicines. The company is currently targeting diseases and disorders of the brain with three key focus areas – depression, neurology and neuropsychiatry.

Zulresso (brexanolone) is Sage Therapeutics’ first marketed drug, which received FDA approval in 2019 for treating postpartum depression (PPD) in adults. The drug is also the first FDA-approved treatment for PPD.

In August 2023, Sage Therapeutics received FDA approval for its second marketed drug Zurzuvae (zuranolone), which was also approved for adult PPD indication. Zurzuvae is also the first oral medicine for PPD treatment.

Though the company also sought approval for Zurzuvae in major depressive disorder (MDD) indication, the FDA issued a complete response letter (CRL) requesting management to conduct more clinical studies. The company is evaluating the necessary steps to address this CRL.

With regard to pipeline development, Sage Therapeutics is currently focused on developing its lead neuropsychiatric and neurology candidates, dalzanemdor (formerly SAGE-718) and SAGE-324, respectively. To better focus on these two candidates, it has paused all its other pipeline programs.

Both Zurzuvae and SAGE-324 are being developed by Sage Therapeutics in partnership with Biogen, per a deal signed in 2020. Per the terms of the agreement, Sage Therapeutics and Biogen will jointly commercialize the drugs in the United States. At the same time, the latter has the sole rights to market in ex-U.S. territories (except for Zurzuvae in Japan, Taiwan and South Korea, where Shionogi holds the rights).

In 2023, Sage Therapeutics’ revenues were $86.5 million, significantly higher than the $7.7 million recorded in the year-ago period.