NeuroSense Therapeutics Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial for its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS). The global Phase 3 trial, named PARAGON, will enroll 300 participants in the U.S. and EU, and will build on promising results from NeuroSense's previous Phase 2b PARADIGM trial. This regulatory approval enables NeuroSense to proceed with the trial, with patient enrollment expected to begin in the coming months. No other organizations are mentioned as recipients of this regulatory approval.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neurosense Therapeutics Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: LN32005) on November 24, 2025, and is solely responsible for the information contained therein.