Audentes sees FDA hold lifted after 3 trial deaths blighted $3B program

Japanese pharma Astellas and its new biotech buyout Audentes got a Christmas gift from the FDA when the agency lifted a clinical hold on its gene therapy.

It’s been a tough 12 months for Audentes. Soon after the high of one year ago, when Astellas spent $3 billion to snap up the Californian biotech, several patients died in a trial of the company’s leading hope, AT132, a gene therapy for the rare disorder known as X-linked myotubular myopathy (XLMTM).