Sanofi be­gins count­down for FDA isat­ux­imab re­view; Cir­rho­sis-fo­cused biotech presents an­oth­er mi­ni IPO

→ Sanofi has a mile­stone to cel­e­brate to­day with its top late-stage prospect isat­ux­imab as the FDA ac­cepts the BLA for re­view. Po­si­tioned as a block­buster ri­val to Darza­lex from J&J and Gen­mab, isat­ux­imab is an an­ti-CD38 drug that’s scored pos­i­tive da­ta in treat­ing re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma. The EMA is al­so eval­u­at­ing a mar­ket­ing ap­pli­ca­tion as Sanofi and its en­trenched com­peti­tors both con­tin­ue to test their re­spec­tive drugs in ear­li­er set­tings.

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