Why BrainStorm Cell Therapeutics (BCLI) Shares Are Plunging Today - Brainstorm Cell (NASDAQ:BCLI)

BrainStorm Cell Therapeutics Inc 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.

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