Pfiz­er and Sang­amo re-open PhI­II of he­mo­phil­ia A gene ther­a­py; AEON head­ed to PhI­II

A year af­ter vol­un­tar­i­ly paus­ing the Phase III study of their he­mo­phil­ia A gene ther­a­py pro­gram, and four months af­ter FDA lift­ed the clin­i­cal hold, Pfiz­er and Sang­amo Ther­a­peu­tics say they will re­sume dos­ing next month.

The move push­es back the orig­i­nal da­ta read­out by two years. At the time of the first pa­tient dos­ing in Oc­to­ber 2020, a Pfiz­er spokesper­son had told End­points News that a piv­otal read­out would come in ear­ly 2022. Fol­low­ing the hur­dles caused by the clin­i­cal hold, Pfiz­er said Fri­day morn­ing the new an­tic­i­pat­ed time­line is the first half of 2024.

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