Fir­dapse fails PhI­II for myas­the­nia gravis as Cat­a­lyst keeps look­ing for ex­pand­ed la­bel

Cat­a­lyst Ther­a­peu­tics’ quest to achieve ex­pand­ed-la­bel ap­proval for its con­tro­ver­sial Fir­dapse drug has run in­to an­oth­er stum­bling block.

In a quar­ter­ly earn­ings re­port Mon­day, the biotech dis­closed that Fir­dapse had not met pri­ma­ry nor sec­ondary end­points in a Phase III tri­al treat­ing myas­the­nia gravis pa­tients. Cat­a­lyst had been mea­sur­ing ef­fi­ca­cy with pa­tient-re­port­ed and physi­cian-rat­ed ex­ams, nei­ther of which reached sta­tis­ti­cal sig­nif­i­cance.

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