Brainstorm Cell Therapeutics ( NASDAQ: BCLI ), a biotech focused on neurodegenerative diseases, said on Monday that the company would submit a Biologics License Application (BLA) to the FDA seeking approval of its NurOwn therapy for amyotrophic lateral sclerosis (ALS).
The plan comes nearly two years after Brainstorm ( BCLI ) announced that a Phase 3 trial for NurOwn did not yield statistically significant results in ALS.
However, Brainstorm ( BCLI ) said a correction was made on the Muscle and Nerve publication regarding Phase 3 ALS data for NurOwn, indicating a statistically significant treatment difference (p=0.050).
"After carefully considering these learnings, the totality of the evidence from NurOwn's® clinical studies, and the feedback received from key opinion leaders and the broader ALS community, we will submit a Biologics License Application to the FDA," Chaim Lebovits, CEO of BCLI said.
"We intend to provide additional updates upon learning whether the FDA files our BLA submission," he added.
The announcement coincided with Brainstorm's ( BCLI ) Q2 2022 financials which showed ~$12.2M of cash, cash equivalents, and short-term bank deposits for the company at the end of the quarter.
The ALS space has garnered regulatory interest in recent months. An ALS candidate developed by Biogen ( BIIB ) and Ionis ( IONS ) is currently under the FDA's priority review.
Weeks ago, Amylyx Pharmaceuticals ( AMLX ) announced that an independent panel of experts of the FDA is set to meet in September to discuss its ALS medication AMX0035 despite a negative vote in March.
For further details see:
BrainStorm to seek FDA approval for ALS therapy despite Phase 3 setback