Shares of Brainstorm Cell Therapeutics (NASDAQ: BCLI) continued to nosedive on Thursday morning as the developer of cellular therapies for neurodegenerative diseases announced the U.S. FDA has rejected its New Biologics License Application (BLA) for NurOwn for the treatment of ALS or Lou Gehrig’s disease.
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Chaim Lebovits, CEO of BrainStorm commented, “While we are disappointed that the FDA has not accepted our BLA for NurOwn in ALS, we remain committed to NurOwn’s advancement as a treatment for this devastating disease. The company intends to request a Type A meeting and looks forward to continued discussions with the FDA.”
The company had backed up its BLA application with data from its Phase 3 NurOwn trial in 200 participants with ALS.