Fi­bro­Gen shares take a beat­ing as CEO re­veals safe­ty da­ta ma­nip­u­la­tion for its block­buster con­tender rox­adu­s­tat

Fi­bro­Gen $FGEN back­tracked on some of the key safe­ty da­ta used to boost hopes for their ane­mia drug rox­adu­s­tat, elim­i­nat­ing its claim of su­pe­ri­or­i­ty over ESAs for a large seg­ment of the pa­tient pop­u­la­tion. And in­vestors quick­ly crushed its shares in re­tal­i­a­tion for the sur­prise dis­crep­an­cies.

Ac­cord­ing to CEO En­rique Con­ter­no, Fi­bro­Gen ex­ecs be­came “aware” that their analy­sis in­clud­ed post hoc changes to strat­i­fi­ca­tion fac­tors used to as­sess the haz­ard ra­tio of their drug — es­sen­tial­ly ma­nip­u­lat­ing the da­ta to en­hance how much the ther­a­py re­duced key risks for pa­tients and shar­ing that false pro­file with in­vestors and reg­u­la­tors. Us­ing pre-spec­i­fied strat­i­fi­ca­tion fac­tors raised the risk on key safe­ty end­points, which re­volved pri­mar­i­ly around MACE, a com­pos­ite end­point of all-cause mor­tal­i­ty, stroke, and my­ocar­dial in­farc­tion.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER