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All Smiles At Sage As Phase III Postpartum Depression Data Are Positive

 
• By Jessica Merrill

The company plans to file an NDA with FDA in the first half of 2018 for an intravenous formulation of brexanolone, which could be the first treatment specifically for postpartum depression.

Newborn baby boy lying on bed, sleeping, close up

SAGE Therapeutics Inc.'s stock surged nearly 50% Nov. 9 after the small biotech reported positive Phase III data on its lead drug brexanolone in patients with postpartum depression. Brexanolone represents a new mechanism of action for treating the serious disorder, and the positive data generated renewed enthusiasm for Sage's pipeline targeting central nervous system disorders.

"These data demonstrate that this type of approach can modulate mood," CEO Jeff Jonas said during a same-day conference call outlining the top-line data

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