Barry Greene, Sage CEO, at Endpoints #JPM23 (Adrien Villez for Endpoints News)

Sage, Bio­gen set their sights on a sum­mer PDU­FA dead­line as zu­ra­nolone de­ci­sion looms

Sage and its part­ners at Bio­gen can now mark a sum­mer date for a go/no go mar­ket­ing de­ci­sion for their block­buster de­pres­sion can­di­date, zu­ra­nolone. The FDA has put the fast-act­ing an­ti-de­pres­sive on the in­side reg­u­la­to­ry track, of­fer­ing a quick pri­or­i­ty re­view and set­ting the PDU­FA for Aug. 5.

That’s a sol­id piece of good news for the de­vel­op­ers, but Bri­an Abra­hams at RBC notes some ma­jor hur­dles ahead. The biggest im­me­di­ate one: the prospect of an ex­pert pan­el re­view, which he thinks ought to be made clear in the next cou­ple of weeks. And that rais­es the pos­si­bil­i­ty of some nasty sur­pris­es, fol­lowed by a tough mar­ket­ing chal­lenge.

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