Bio­Marin says PhI­II gene ther­a­py study par­tic­i­pan­t's can­cer is un­re­lat­ed to ther­a­py

As the FDA has de­layed any hope of Bio­Marin launch­ing its he­mo­phil­ia A gene ther­a­py un­til next year at the ear­li­est, the com­pa­ny said in an SEC fil­ing Mon­day that a par­tic­i­pant in one of its Phase III stud­ies for the ther­a­py was di­ag­nosed with a type of can­cer known as B-cell acute lym­phoblas­tic leukemia.

Af­ter sub­mit­ting the safe­ty re­port to FDA, Bio­Marin said it “be­lieves at this time that this can­cer is un­re­lat­ed” to the treat­ment, known as val­oc­toco­gene rox­a­parvovec. None of the gene ther­a­py’s on­go­ing tri­als have been halt­ed as a re­sult, the com­pa­ny said. On the sta­tus of its in­ves­ti­ga­tion in­to this case of B-ALL, Bio­Marin told in­vestors:

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