Chaim Lebovits, BrainStorm CEO

Af­ter rare pub­lic brush­back, FDA again turns away Brain­Stor­m's ALS drug with RTF let­ter

As a cell ther­a­py biotech de­vel­op­ing a new treat­ment for ALS at­tempt­ed to ap­proach the FDA with its ap­pli­ca­tion, it found the agency’s doors slammed shut.

Brain­Storm Cell Ther­a­peu­tics re­ceived a re­fusal to file (RTF) let­ter from reg­u­la­tors, who swat­ted away the BLA with­out re­view­ing it, for its ALS ther­a­py NurOwn, the biotech an­nounced Thurs­day. The move comes af­ter the FDA, in a rare pub­lic slap­down, said in March 2021 that Phase III da­ta were “not at all sta­tis­ti­cal­ly sig­nif­i­cant.”

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