Sage Therapeutics said Monday that it may need to reduce costs, including through employee layoffs, following the Food and Drug Administration’s denial of its rapid-acting drug for major depressive disorder.
On Friday, the agency granted market clearance for the drug, called Zurzuvae, to treat women with postpartum depression, a smaller commercial market. Sage failed to convince regulators to also approve the drug for depression, a broader condition.
advertisement
“We don’t agree with the FDA review,” Sage CEO Barry Greene said during an earnings call, a point he made repeatedly. “We are evaluating the [FDA’s response letter] and as soon as we can provide more clarity, we will, on what the next steps are.
Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!
GET STARTED Log In
Previous article：
Change Healthcare can notify patients about the breach, HHS says
Next article： Psychedelics group wrestles with new pharma identity
Next article： Psychedelics group wrestles with new pharma identity
