Fda review of citizen petition offers a fresh look at nurown®'s evidence of treatment effectiveness

Brainstorm to continue with planned phase 3b trial and remains committed to advancing access for people living with als new york , july 8, 2025 /prnewswire/ -- brainstorm cell therapeutics inc. (nasdaq: bcli), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today acknowledged that the u.s. food and drug administration's (fda) consideration of a citizen petition requesting a new review of the data supporting nurown will provide a critical opportunity to reaffirm its potential as therapy for amyotrophic lateral sclerosis (als). a citizen petition, submitted to the fda under the federal food, drug, and cosmetic act (21 cfr § 10.30), is a regulatory process that allows any interested party to formally request the agency to take action on specific matters, such as reviewing data, issuing new guidance, or taking enforcement action.
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