Astellas, after years of gene therapy woes, gets rare boost with FDA lifting of Pompe clinical hold

The FDA has handed a boost to Astellas Pharma’s stuttering push into gene therapy by lifting the clinical hold on a phase 1/2 study in late-onset Pompe disease (LOPD). Astellas was forced to pump the brakes on the AT845 program last year after a participant developed peripheral sensory neuropathy.