The FDA just signed off on a For­mu­la 1 piv­otal track for Sage's post­par­tum de­pres­sion drug

Sage Ther­a­peu­tics says the FDA has signed off on an as­ton­ish­ing­ly short clin­i­cal de­vel­op­ment path­way for post­par­tum de­pres­sion which may al­low for an ap­proval af­ter a pair of tiny Phase II stud­ies which are al­ready un­der­way.

These two mid-stage stud­ies — 202B and 202C — will read out in the sec­ond half of next year. And Cam­bridge, MA-based Sage says that the min­utes of its FDA meet­ing make clear that the biotech on­ly needs to make a few small ad­just­ments, in­clud­ing an in­crease in sam­ple size, to make these stud­ies reg­is­tra­tional.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.