NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further Updates
NeuroSense Therapeutics Ltd. (NRSN)
Company Research
Source: PR Newswire
Dossier submission planned for Q2 2025; regulatory decision expected by Q1 2026 Estimated potential market opportunity: peak of $100M to $150M in annual revenueCompany aims to expand approval efforts to additional global marketsCAMBRIDGE, Mass., Oct. 15, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, provided a further update on its plans to file for early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based on promising results from the Company's Phase 2b ALS PARADIGM clinical trial, supported by additional clinical and preclinical data.This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% comp
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NRSN
News
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MND [Yahoo! Finance]Yahoo! Finance
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MNDPR Newswire
- NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA SubmissionPR Newswire
- EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission [Yahoo! Finance]Yahoo! Finance
- New Analysis Shows PrimeC Significantly Improves Key miRNAs in ALS PatientsPR Newswire
NRSN
Sec Filings
- 11/19/24 - Form F-1
- 11/12/24 - Form 6-K
- 10/31/24 - Form 6-K
- NRSN's page on the SEC website