FDA forces Con­cert Phar­ma to hit the brakes on a mid-stage study so it can re­view tox stud­ies

Con­cert Phar­ma­ceu­ti­cals has been slammed with a clin­i­cal hold on a Phase IIa study of its drug CTP-543 for alope­cia area­ta.

The biotech made it sound in­no­cent enough. The FDA, it says, needs to re­view “cer­tain re­cent­ly com­plet­ed non-clin­i­cal tox­i­col­o­gy stud­ies.” The agency did not cite a safe­ty con­cern, Con­cert added in a brief state­ment, and reg­u­la­tors want­ed to re­view the da­ta to sup­port its plans for a one-year dos­ing sched­ule of their new ver­sion of Jakafi.

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