Adcomm recommends FDA reject BrainStorm’s ALS drug after company filed over protest

A pan­el of in­de­pen­dent ex­perts on Wednes­day rec­om­mend­ed the FDA re­ject an ex­per­i­men­tal ALS drug de­vel­oped by the biotech Brain­Storm Cell Ther­a­peu­tics, mark­ing an­oth­er de­feat for the long-em­bat­tled com­pa­ny.

Mem­bers of the Cel­lu­lar, Tis­sue, and Gene Ther­a­pies Ad­vi­so­ry Com­mit­tee said by a 17-1 vote that Brain­Storm’s drug, known as NurOwn, did not demon­strate sub­stan­tial ev­i­dence of ef­fec­tive­ness for the treat­ment of mild to mod­er­ate ALS. The FDA has un­til Dec. 8 to ap­prove or re­ject the drug.

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