Chaim Lebovits, BrainStorm CEO

Af­ter last year's pub­lic re­jec­tion, Brain­Storm to give ALS cell ther­a­py an­oth­er shot de­spite still flunk­ing a re-an­a­lyzed PhI­II

Af­ter a rare pub­lic re­jec­tion from the FDA last year, Brain­Storm Cell Ther­a­peu­tics is head­ed back to the reg­u­la­tor with what it claims is a “cor­rec­tion” to Phase III da­ta for its ALS in­ves­ti­ga­tion­al ther­a­py NurOwn.

The FDA re­ject­ed the treat­ment last year af­ter it flunked pri­ma­ry and sec­ondary goals in No­vem­ber 2020. From day one, the biotech has tried po­si­tion­ing the ther­a­py, which us­es stem cells to se­crete nerve growth fac­tors, as hav­ing a chance of suc­cess at the FDA de­spite the re­sults. The biotech once again thinks there’s a chance at ap­proval and is head­ed back to the FDA with a BLA, but there’s still a ma­jor fork in the road.

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