Welcome to our dedicated page for Neurosense Therapeutics news (Ticker: NRSN), a resource for investors and traders seeking the latest updates and insights on Neurosense Therapeutics stock.
NeuroSense Therapeutics Ltd (NRSN) is a clinical-stage biotechnology company advancing therapies for neurodegenerative diseases, with a primary focus on Amyotrophic Lateral Sclerosis (ALS). This news hub provides investors and stakeholders with timely updates on PrimeC development, clinical trial progress, and strategic initiatives.
Access consolidated, verified information about NRSN's scientific advancements including Phase 2b trial results, regulatory submissions, and intellectual property milestones. Our repository features press releases covering clinical data analyses, partnership announcements, and biomarker research developments specific to ALS pathology.
Key updates include progress on PrimeC's extended-release formulation, patent grants for combination therapies, and FDA/Health Canada regulatory interactions. Bookmark this page for objective reporting on trial enrollment status, peer-reviewed publication alerts, and neurodegenerative treatment innovations.
NeuroSense Therapeutics has announced significant positive results from its 18-month PARADIGM study evaluating PrimeC for treating Amyotrophic Lateral Sclerosis (ALS). The study demonstrated that patients receiving PrimeC from the start showed a 33% slower disease progression (p=0.007) and a 58% improvement in survival rates compared to those who initially received placebo before switching to PrimeC.
The study revealed a notable difference of nearly 8 points in ALSFRS-R scores between the group treated with PrimeC for 18 months versus those who received placebo for 6 months before transitioning to PrimeC. The results will be presented at the 2024 International Symposium on ALS/MND by Prof. Merit Cudkowicz, with FDA meeting outcomes expected in the coming days.
NeuroSense Therapeutics has secured a $5 million private placement through the sale of ordinary shares and warrants at a premium of 25% above market price. The agreement includes selling 4,000,000 ordinary shares and 8,000,000 warrants at a combined price of $1.25 per share with two accompanying warrants. The five-year warrants have an exercise price of $1.25 per share. The investment comes from a single investor and the company's CEO, with proceeds to be delivered in two tranches, expected to close in December 2024. The funds will be used for general corporate and working capital purposes.
NeuroSense Therapeutics (NASDAQ: NRSN) announces its participation in the 2024 International Symposium on ALS/MND in Montreal, Canada, December 6-8, 2024. The company will present findings from its Phase 2b PARADIGM trial of PrimeC, a potential ALS treatment.
Prof. Merit Cudkowicz from Massachusetts General Hospital will present clinical outcomes, while Dr. Cristian Lunetta will share biomarker analysis from the PARADIGM trial. The NeuroSense management team, including CEO Alon Ben-Noon and other executives, will attend the symposium, which serves as the premier global forum for ALS research.
NeuroSense Therapeutics (NASDAQ: NRSN) has secured a Type C meeting with the FDA on November 6, 2024, to discuss the design of its Phase 3 clinical trial for PrimeC, a potential ALS treatment. The meeting will focus on finalizing trial design and reviewing NDA submission readiness.
PrimeC has demonstrated significant results in reducing disease progression markers. The company plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The potential Canadian market opportunity is estimated at $100-150 million in annual revenue. Clinical findings showed PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.
NeuroSense Therapeutics has announced significant findings from its PARADIGM clinical trial of PrimeC for ALS treatment. The study revealed that PrimeC effectively regulates microRNAs (miRNAs), which are important genetic markers controlling gene expression in ALS progression. The treatment showed a 2-fold reduction in several miRNAs, with no similar changes observed in the placebo group. PrimeC enhances miRNA maturation by influencing Dicer, an endonuclease that processes precursor miRNA into active forms, potentially addressing the underlying mechanisms of ALS. This breakthrough suggests PrimeC's potential as a disease-modifying treatment rather than just symptom management.
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.
NeuroSense Therapeutics (NASDAQ: NRSN) has initiated the regulatory process for early commercialization approval of PrimeC, its ALS treatment, under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This decision follows positive Phase 2b trial results showing PrimeC reduces ALS disease progression by 36% (p=0.009) and improves survival rates by 43% compared to placebo.
The company plans to seek approval in additional countries based on these promising results. NeuroSense CEO, Alon Ben-Noon, expressed confidence in PrimeC's potential to address urgent unmet needs in ALS treatment and the company's commitment to expediting access to this therapy.
NeuroSense Therapeutics announced the acceptance of two abstracts focusing on their lead drug candidate, PrimeC, for Amyotrophic Lateral Sclerosis (ALS) treatment at the 2024 Annual Northeastern ALS Consortium Meeting. The abstracts will present data from NeuroSense's Phase 2b PARADIGM study.
Dr. Merit Cudkowicz from Massachusetts General Hospital will present clinical outcomes, while Dr. Cristian Lunetta from NEMO in Milan will discuss biomarker analysis. Recent findings showed PrimeC reduced disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough ALS therapy.
NeuroSense Therapeutics (Nasdaq: NRSN) announced the issuance of a pivotal U.S. patent for its novel PrimeC formulation, a leading drug candidate for treating Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's. The patent, titled 'Compositions comprising Ciprofloxacin and Celecoxib' (US Patent No. US 12,097,185), extends PrimeC's intellectual property protection by an additional four years, now covering it until 2042. PrimeC combines ciprofloxacin and celecoxib in unique doses with a slow-release technology to enhance therapeutic synergy and efficacy. Recent clinical findings showed PrimeC reduced disease progression by 36% and improved survival rates by 43% compared to placebo. NeuroSense CEO Alon Ben-Noon emphasized the innovative formulation's potential to optimize ALS treatment.
NeuroSense Therapeutics (Nasdaq: NRSN) has regained compliance with Nasdaq's minimum bid price requirement. The company, which develops treatments for severe neurodegenerative diseases, received notice from Nasdaq confirming that it has met the Rule 5550(a)(2) criteria. To achieve this, NeuroSense's ordinary shares maintained a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, accomplished on September 20, 2024.
CEO Alon Ben-Noon expressed satisfaction with this development, viewing it as an important step that reflects the company's commitment to advancing PrimeC. He also mentioned positive momentum following Phase 2b trial results and plans to initiate a Phase 3 trial in the US, along with ongoing discussions with potential partners.
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