Brain­storm’s ral­ly fiz­zles af­ter in­vestors turn sour on ques­tion­able ALS da­ta

Brain­storm Cell Ther­a­peu­tics worked hard Mon­day morn­ing to make the case that a small Phase II study of its lead stem cell ther­a­py for amy­otroph­ic lat­er­al scle­ro­sis (ALS) pro­vid­ed plen­ty of rea­sons for op­ti­mism about Phase III. But af­ter tak­ing a sec­ond look at the da­ta, a short-lived pop in the com­pa­ny’s share price turned in­to a sharp de­cline by mid-morn­ing.

The Is­raeli biotech $BCLI cut it­self con­sid­er­able slack in the study, set­ting a p val­ue of <0.1 for sta­tis­ti­cal sig­nif­i­cance. They al­so set up a sub­set analy­sis to ex­am­ine the ef­fect on pa­tients, “ex­clud­ing slow­ly pro­gress­ing pa­tients who are less like­ly to have a de­tectable ben­e­fit from NurOwn.” And they added a sur­vey of physi­cians to sup­port their con­tention that even a mod­est change in the slope of de­cline for pa­tients would be “clin­i­cal­ly mean­ing­ful.”

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