Astel­las paus­es Au­den­tes' gene ther­a­py pro­gram again af­ter 'ab­nor­mal' liv­er tests in yet an­oth­er set­back

Au­dentes’ trou­bled the gene ther­a­py pro­gram for a rare and dev­as­tat­ing mus­cle wast­ing dis­ease isn’t yet out of the woods.

The Astel­las sub­sidiary has once again halt­ed a tri­al for its X-linked my­otubu­lar my­opa­thy can­di­date, the Japan­ese Phar­ma an­nounced, af­ter a se­ri­ous ad­verse event emerged in which re­searchers ob­served “ab­nor­mal liv­er func­tion tests” with­in the first month of dos­ing. The hold is vol­un­tary for now, but Astel­las left open the pos­si­bil­i­ty of re­ceiv­ing an of­fi­cial FDA no­tice.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER