Is sec­ond time the charm for ozan­i­mod? Cel­gene starts to find out with EMA fil­ing

Cel­gene has of­fi­cial­ly em­barked on ozan­i­mod’s come­back reg­u­la­to­ry jour­ney, sub­mit­ting an ap­pli­ca­tion to the EMA days be­fore it plans to knock on the FDA’s door — just in time for the dead­line it has set for it­self.

Say­ing Cel­gene — and Bris­tol-My­ers, which is set to ac­quire the biotech as long as the grow­ing in­vestor op­po­si­tion doesn’t de­rail the deal — has a lot rid­ing on the de­ci­sion would be an un­der­state­ment. Fol­low­ing an em­bar­rass­ing refuse-to-file episode with the FDA last Feb­ru­ary, pos­i­tive progress here is cru­cial not just to ma­te­ri­al­ize ozan­i­mod’s block­buster promis­es as a cash cow as Revlim­id ap­proach­es a patent cliff, but to prove Cel­gene’s team still pos­sess­es the de­vel­op­ment shrewd­ness that marked the com­pa­ny for years.

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