Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Sev­en months af­ter Astel­las shelled out $3 bil­lion to ac­quire the gene ther­a­py play­er Au­dentes, the biotech com­pa­ny’s lead pro­gram has been put on hold fol­low­ing the death of 2 pa­tients tak­ing a high dose of their treat­ment. And there was an­oth­er se­ri­ous ad­verse event record­ed in the study as well, with a to­tal of 3 “old­er” pa­tients in the study af­fect­ed.

The in­ci­dents are de­rail­ing plans to file for a near-term ap­proval, which had been ex­pect­ed right about now.

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