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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER