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0.0344827586206895 0.00862068965517242 0.0246551724137931 0.0344827586206897 -0.0431034482758621 -0.0862931034482759 -0.0948275862068966 -0.0948275862068966
Stock impact report

NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS

NeuroSense Therapeutics Ltd. (NRSN) 
Company Research Source: PR Newswire
CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).With the FDA's clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense's Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favora Show less Read more
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