Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfiz­er’s am­bi­tious plan to take a Phase II study of its BC­MA CD3-tar­get­ed bis­pe­cif­ic an­ti­body el­ranatam­ab (PF-06863135) and run it through to an ac­cel­er­at­ed ap­proval has de­railed.

The phar­ma gi­ant said in a re­lease this morn­ing that they have halt­ed en­roll­ment for their Mag­net­isMM-3 study af­ter re­searchers tracked three cas­es of pe­riph­er­al neu­ropa­thy in the on­go­ing Phase I. They are now shar­ing in­fo with the FDA as they ex­plore the red safe­ty flag.

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