Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.
Brainstrom's therapy, NurOwn, is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, which affects nerve cells in the brain and spinal cord.
The FDA had in November last year refused to accept the application for the therapy after BrainStorm failed to meet the main goal in a late-stage study.
Over the last one year, the FDA has given accelerated approvals to Amylyx Pharmaceuticals' (AMLX.O) drug Relyvrio and Biogen's (BIIB.O) Qalsody for treatment of ALS.
A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.
Persons:
Andrew Kelly, Lou Gehrig's Disease, Amylyx, Mariam Sunny, Leroy Leo, Krishna Chandra
Organizations:
Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug, Cell Therapeutics, Amylyx Pharmaceuticals, ALS Association, Thomson
Locations:
White Oak , Maryland, U.S, Bengaluru