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NEWS
NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further Updates
NeuroSense Therapeutics (Nasdaq: NRSN) has provided an update on its plans to file for early commercialization approval for PrimeC, its ALS treatment, under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. The company plans to submit its dossier in Q2 2025, with an expected regulatory decision by Q1 2026.
The submission is based on promising results from the Phase 2b ALS PARADIGM clinical trial, which showed PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo. NeuroSense estimates a potential peak annual revenue of $100M to $150M in Canada, driven by ALS prevalence and unmet treatment demand.
The company aims to expand approval efforts to additional global markets as part of its strategy to make PrimeC accessible worldwide and drive sustainable growth.
The submission is based on promising results from the Phase 2b ALS PARADIGM clinical trial, which showed PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo. NeuroSense estimates a potential peak annual revenue of $100M to $150M in Canada, driven by ALS prevalence and unmet treatment demand.
The company aims to expand approval efforts to additional global markets as part of its strategy to make PrimeC accessible worldwide and drive sustainable growth.
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