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：
STAT series 'Denied by AI' wins major journalism prizes
Next article： In age of alternative facts, a scholarly course on calling out crap
Next article： In age of alternative facts, a scholarly course on calling out crap
