Sage momentum checked by PDUFA extension

Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ (Nasdaq: SAGE) Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it.

News that the previous December 19, 2018 PDUFA goal date had been extended by three months to March 19, 2019, led shares in Sage to close more than 2% down on Tuesday.

After the recent positive FDA Advisory Committee meeting, Sage submitted a proposed Risk Evaluation and Mitigation Strategies program with Elements to Ensure Safe Use in response to the FDA’s request.