FDA lifts clinical hold on Audentes' gene therapy program after three patient deaths triggered alarms
The big prize of Astellas’ $3 billion gene therapy buyout last year is one step closer to getting back on track.
The FDA lifted its clinical hold of Audentes Therapeutics’ trial for AT132 on Monday, clearing the way back to the clinic for a gene therapy aimed at treating X-linked myotubular myopathy. Regulators had pressed pause in June after two patients died on the high dose of the therapy, a third individual in the study also died in August from gastrointestinal bleeding.
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