BrainStorm Cell Therapeutics Inc (BCLI)

[Fmello]

https://www.biospace.com/article/als-thought-leaders-weigh-in-ahead-of-second-amylyx-adcomm-/?fbclid=IwAR1Z9kf0p4GnPIiVjIgMMrlSext2UfKhmEhzV-GQIG_hNS4u86nxcRVgziI

The ALS community has been calling for regulatory flexibility since the FDA approved Biogen's Aduhelm for Alzheimer’s in June 2021.

Of the Sept. 7 adcomm, Stacy Lindborg, Ph.D., EVP and chief development officer at BrainStorm Cell Therapeutics said, “We hope that a positive…recommendation would encourage the FDA to exercise regulatory flexibility.”

BrainStorm is in the final stages of completing a BLA for NurOwn, an ALS candidate made up of autologous mesenchymal stem cells (MSCs) and neurotrophic factors (NTFs). Lindborg noted that the totality of evidence for NurOwn “[brings] to light valuable insights on the nature of ALS research and biomarkers as predictors of clinical response.”