Sage, Biogen head to FDA with $3.1B depression drug; Sana puts down $50M to tap Beam's CRISPR tech
Weeks after announcing they would drop a pair of studies deemed unnecessary to file the depression drug zuranolone for approval, Sage and Biogen are going for it.
Following a pre-NDA meeting with the FDA, the partners say they plan to submit an NDA in the second half of 2022 for major depressive disorder, with a second for postpartum depression to follow in 2023.
“We have identified what we believe is the most efficient path forward for an FDA filing and potential approval,” Sage CEO Barry Greene said in a statement.
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