FDA declines to free MaaT's microbiome drug from clinical hold after a year

MaaT Pharma is not getting out from under an FDA clinical hold for its microbiome drug any time soon.

MaaT013, in development for steroid-resistant acute graft-versus-host disease (aGvHD), was placed on hold a year ago, halting a phase 3 trial in the U.S. The FDA had concerns about several clinical and manufacturing issues.