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# BrainStorm Pulls NurOwn BLA
- URL: https://www.fdaweb.com/brainstorm-pulls-nurown-bla/
- Published: 2023-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:13:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155589

BrainStorm Cell Therapeutics says it is withdrawing its BLA for NurOwn to treat amyotrophic lateral sclerosis (ALS), a move it says was coordinated with FDA. A company [statement](https://ir.brainstorm-cell.com/2023-10-18-BrainStorm-Cell-Therapeutics-to-Meet-with-US-FDA-to-Discuss-Development-Plan-for-NurOwn-as-a-Treatment-of-ALS?ref=fdaweb.com) says the agency invited BrainStorm to request an expedited face-to-face meeting to discuss a path forward for NurOwn. BrainStorm says it will work with FDA to define a path forward, recognizing that an additional pivotal trial will be necessary.

The company says the NurOwn technology platform (autologous MSC-NTF cells) “represents a promising investigational therapeutic approach to targeting disease pathways important in neurological disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases.”