Brain­Storm with­draws ALS drug ap­pli­ca­tion af­ter neg­a­tive ad­comm vote

Brain­Storm Cell Ther­a­peu­tics is pulling its ap­pli­ca­tion for a con­tro­ver­sial ALS drug a few weeks af­ter a group of out­side ex­perts said the drug like­ly doesn’t work.

The biotech with­drew its BLA for the drug, called NurOwn, in a de­ci­sion it said “was co­or­di­nat­ed with FDA and is viewed by FDA as a with­draw­al with­out prej­u­dice,” ac­cord­ing to a press re­lease. Pre­vi­ous­ly, the agency’s de­ci­sion would’ve had to come be­fore Dec. 8.

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