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Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

Phase III Data Seen As Underwhelming

Executive Summary

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption

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After CRL In MDD, Sage/Biogen’s Zuranolone Would Need More Effectiveness Data

Zurzuvae becomes first oral drug for postpartum depression but will need at least one additional study to enter larger major depressive disorder market after US FDA cites a lack of effectiveness. Continued MDD development in doubt with both Sage and partner Biogen in cost-cutting frame.

Reprioritization On Cards After Sage/Biogen’s Zurzuvae Receives CRL For MDD

The firms’ Zurzuvae has become the first oral drug to win US approval for postpartum depression but a thumbs down in the larger major depressive disorder indication has raised concerns that Biogen could pull out of the partnership as Sage turns its efforts to cutting costs.

Praxis Moves Away From Depression With Surprising Phase II/III Failure

With GABA-A modulator PRAX-114 missing all endpoints in a monotherapy study, Praxis will cease development of that drug and focus on its candidates for essential tremor and epilepsy.

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