FDA Refuses To Accept BrainStorm Cell's Lead Candidate For Amyotrophic Lateral Sclerosis

• BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI) received a refusal to file letter from the FDA regarding its marketing application seeking approval for NurOwn for amyotrophic lateral sclerosis (ALS).

• The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

• The investigators said, "while the pre-specified primary outcome measure was not met, there were participants with beneficial clinical effects and overall changes in relevant biomarkers of drug effect."

• Related:  BrainStorm Cell ALS Candidate Shows Benefit In Patients With Less Severe Disease.

• The company submitted the application in August after a correction was made to the Muscle and Nerve publication from December 2021 describing the results of NurOwn's Phase 3 trial in ALS following new clinical analyses, which strengthens the company's original conclusions from the trial.

• Price Action: BCLI shares are down 46.1% at $1.56 on the last check Thursday.

See more from Benzinga

• Becton Dickinson's FY23 Guidance Trails Wall Street View Reflecting Foreign Currency Impact

• Troubled FTX Faces SEC Probe And 'Urgently Needs' $8B To Avoid Bankruptcy, NIO Posts Wider Q3 Loss, AstraZeneca Ditches US Application Submission For COVID-19 Shot: Top Stories Thursday, Nov. 11

• Xi Jinping Reportedly Asks China Army To 'Concentrate All Energy On Fighting A War' Amid Uncertain, Unsta

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.