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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