Summary by Moomoo AI
NeuroSense Therapeutics Ltd., a late-clinical stage biotech company, announced on October 15, 2024, its plans for early commercialization of its ALS treatment, PrimeC, in Canada. The company is preparing to submit a dossier for regulatory approval in Q2 2025, with a decision expected by Q1 2026. This follows promising results from the Phase 2b ALS PARADIGM clinical trial and additional data. NeuroSense is targeting a significant market opportunity in Canada, estimating peak annual revenues between $100M to $150M. The company also plans to seek approval in other global markets. PrimeC has shown to significantly reduce disease progression and improve survival rates in clinical trials. The drug is a combination of ciprofloxacin and celecoxib, designed to target multiple mechanisms of ALS. NeuroSense has received Orphan Drug Designation for PrimeC from both the FDA and the European Medicines Agency. The company's broader strategy is to address the unmet medical needs in neurodegenerative diseases and drive sustainable growth.
