With a big as­sist from the FDA, Sage plots a swift march through PhI­II for oral de­pres­sion drug -- mar­ket cap swells $1B-plus

The FDA is putting Sage Ther­a­peu­tics’ oral de­pres­sion drug SAGE-217 on their in­side track, bless­ing a fast-paced late-stage strat­e­gy that in­cludes des­ig­nat­ing their on­go­ing study for post-par­tum de­pres­sion a piv­otal ef­fort.

Ac­cord­ing to Sage ex­ecs $SAGE, reg­u­la­tors will de­mand on­ly one more late-stage study, which will now get un­der­way in a mat­ter of months. Sage plans to eval­u­ate “two weeks of 20mg or 30mg SAGE-217 treat­ment com­pared to place­bo in 450 pa­tients with MDD, with four weeks of ad­di­tion­al fol­low-up.”

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