Abl­ynx spikes as PhI­II aTTP study comes through with promis­ing da­ta, set­ting up an FDA ap­pli­ca­tion

Abl­ynx shares {$ABLX BB} surged 25% this morn­ing af­ter the Bel­gian biotech re­port­ed that its lead drug for an ul­tra-rare blood clot­ting dis­ease hit the pri­ma­ry and two key sec­ondary end­points in the piv­otal Phase III study. And with the Eu­ro­pean ap­pli­ca­tion al­ready un­der re­view with the mid-stage re­sults, Abl­ynx says it will line up a US fil­ing planned for next year.

The drug capla­cizum­ab tar­gets ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra (aTTP), a dis­or­der that trig­gers low platelet counts. In the Phase III study, re­searchers re­port­ed top-line re­sults that in­clud­ed a sig­nif­i­cant (p=0.01) re­duc­tion in the time it took for the platelet counts to re­turn to nor­mal for the drug arm — a like­ly in­di­ca­tor for the pre­ven­tion of mi­crovas­cu­lar throm­bo­sis.

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