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

Executive Summary

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.

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Zulresso Is Sage’s First Step In Postpartum Depression Treatment

I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.

Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval

After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.

Keeping Track: Good News/Bad News For Pfizer; Filings For Brexanolone, Risankizumab

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