BCLI - Brainstorm granted FDA AdCom meeting for ALS therapy

2023-03-27 06:48:42 ET

• BrainStorm Cell Therapeutics ( NASDAQ: BCLI ) announced Monday that the FDA is expected to hold an advisory committee meeting to discuss the marketing application for its lead asset NurOwn targeted at rare neurodegenerative disorder amyotrophic lateral sclerosis (ALS).
• In November, the FDA declined to accept its biologics license application (BLA) for NurOwn as a treatment for ALS.
• On Monday's release, BrainStorm ( BCLI ) said it submitted an amendment to the BLA to respond to most of the FDA's concerns.
• The company has also requested the FDA's biologics unit to utilize a regulatory process called File Over Protest to advance its marketing request to an AdCom meeting as quickly as possible.
• "Our goal has always been to make NurOwn available to people living with ALS as quickly as possible, therefore we chose the File Over Protest pathway since this offered the fastest path to an ADCOM and regulatory decision relative to other pathways provided by the FDA," Chief Executive Chaim Lebovits remarked.
• Read: Seeking Alpa analyst E. Roudasev issued a Buy rating on BrainStorm ( BCLI ) in August, noting that "exciting times are ahead for the ALS space."

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