FDA re­jects Am­gen’s os­teo­poro­sis drug ro­mo as ri­val Ra­dius sur­pris­es with a new CEO

Af­ter miss­ing a key sec­ondary end­point for its big os­teo­poro­sis drug ro­mosozum­ab last fall and then run­ning in­to a dis­turb­ing safe­ty is­sue two months ago, Am­gen $AMGN said Sun­day that the FDA has hand­ed the big biotech a re­jec­tion on its mar­ket­ing ap­pli­ca­tion, a wide­ly an­tic­i­pat­ed set­back for the drug de­vel­op­er that will give ri­val Ra­dius a shot at es­tab­lish­ing a big lead in what had once been thought of as a horse race. And with­in hours of the CRL news from Am­gen, Ra­dius put out the word that it is mak­ing a change at the helm, with long­time CEO Bob Ward out and No­vo US pres­i­dent Jes­per Høi­land step­ping in to or­ches­trate the cam­paign for Ra­dius’ first mar­ket launch.

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