Welcome to our dedicated page for NeuroSense Therapeutics Ltd. Ordinary Shares news (Ticker: NRSN), a resource for investors and traders seeking the latest updates and insights on NeuroSense Therapeutics Ltd. Ordinary Shares stock.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. These diseases encompass Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, among others.
The company's flagship product, PrimeC, is a novel extended-release oral formulation, combining ciprofloxacin and celecoxib in a specific ratio designed for synergistic effect. PrimeC aims to target several key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. The formulation has shown promising results in clinical trials, including a significant slowing of disease progression in Phase 2b studies.
In their recent PARADIGM Phase 2b clinical trial, NeuroSense demonstrated compelling data with a 37% reduction in the progression of ALS, with further subgroup analysis showing even higher efficacy in specific patient populations. This trial's success propelled the company towards preparing for a Phase 3 pivotal trial, with extensive collaboration and validation from industry experts.
NeuroSense has been active in forming strategic partnerships to enhance its research and development capabilities. Notable collaborations include agreements with Lonza for biomarker development, and Genetika+ for Alzheimer's disease drug development. These partnerships leverage cutting-edge technologies to optimize clinical outcomes and advance the company's therapeutic solutions.
Financially, NeuroSense reported an increase in R&D expenses from $6.4 million in 2022 to $7.6 million in 2023, reflecting its investment in expanding its workforce and clinical programs. Conversely, general and administrative expenses saw a decrease, contributing to an efficient allocation of resources. As of December 31, 2023, the company had a cash position of approximately $2.6 million.
With multiple ongoing projects and a robust pipeline, NeuroSense is set to play a significant role in addressing the unmet medical needs in neurodegenerative diseases. The company's dedication to advancing research and developing novel therapies positions it as a key player in biotech innovation.
For more information, visit NeuroSense's investor relations website at https://neurosense.investorroom.com/.
NeuroSense Therapeutics (Nasdaq: NRSN) reported Q3 2024 financial results and provided business updates. Key highlights include completion of their 18-month Phase 2b PARADIGM study for PrimeC in ALS treatment, showing 33% slower disease progression and 58% improved survival rates. The company secured a $5 million private placement in December 2024 and received positive FDA feedback for their planned Phase 3 study.
Financial results show R&D expenses decreased 14% to $4.61 million for the nine months ended September 30, 2024. The company had $0.34 million in cash as of September 30, 2024, not including the December financing. NeuroSense plans early commercialization in Canada with potential market opportunity of $100M-$150M in peak annual revenue, targeting a 2026 launch.
NeuroSense Therapeutics (NASDAQ: NRSN) has received positive FDA feedback on their Phase 3 study design for PrimeC, their ALS treatment candidate. Following a Type C meeting with the FDA, the company plans to submit a final protocol in H1 2025 and begin the pivotal Phase 3 study by mid-2025.
The planned Phase 3 study will be randomized, multi-center, multinational, double-blind, and placebo-controlled, involving approximately 300 patients in a 2:1 ratio (PrimeC to placebo). The study will include a 12-month treatment period followed by a 12-month open label extension where all participants will receive PrimeC.
This development follows the completion of their PARADIGM Phase 2b clinical trial, where PrimeC demonstrated significant impact on slowing disease progression and increasing survival rates in ALS patients.
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.
FAQ
What is the current stock price of NeuroSense Therapeutics Ltd. Ordinary Shares (NRSN)?
What is the market cap of NeuroSense Therapeutics Ltd. Ordinary Shares (NRSN)?
What is NeuroSense Therapeutics' main focus?
What is PrimeC?
What were the results of the PARADIGM Phase 2b trial?
Who are NeuroSense's key collaborators?
What are the financial highlights for NeuroSense in 2023?
What diseases is NeuroSense targeting?
What is the status of PrimeC's clinical trials?
How does PrimeC work?
Is PrimeC FDA approved?
How can I get more information about NeuroSense?
