Neurosense Therapeutics Ltd Stock Price, News & Analysis

NeuroSense Therapeutics (NASDAQ: NRSN) is developing PrimeC, a groundbreaking combination therapy for ALS that has shown remarkable clinical results. The Phase 2b PARADIGM trial demonstrated a 36% reduction in disease progression and a 43% improvement in survival rates.

PrimeC is an extended-release oral formulation combining two FDA-approved drugs - ciprofloxacin and celecoxib - targeting multiple ALS pathological mechanisms simultaneously. The therapy has received Orphan Drug Designation from both the FDA and European Medicines Agency.

Alliance Global Partners maintains a 'buy' rating with a $7.50 price target, representing over 500% premium from current prices. The company recently entered a binding term sheet for a potential pharma partnership, with similar deals in the market ranging from Eli Lilly's $577 million agreement with QurAlis to GSK's $1.5 billion collaboration with Alector.

Key upcoming milestones include Canadian market approval submission in Q3 2025, regulatory decision in early 2026, and Phase 3 trial initiation in mid-2025.

NeuroSense Therapeutics (Nasdaq: NRSN) has announced regaining compliance with Nasdaq's stockholders' equity requirement, ensuring continued listing on The Nasdaq Capital Market. The company successfully improved its balance sheet by raising new equity and reducing liabilities, exceeding the required $2.5 million threshold.

Key developments include a $5 million financing completed in December 2024, following a Nasdaq hearing on August 1, 2024. The company is preparing to transition into a pivotal Phase 3 study for PrimeC, following promising Phase 2b PARADIGM study results.

NeuroSense will be subject to a mandatory panel monitor for one year from January 3, 2025. If the company fails to maintain compliance during this period, it will not receive additional time but can request a new hearing before any delisting action.

NeuroSense Therapeutics (NRSN) has entered into a binding term sheet with a leading global pharmaceutical company for its ALS treatment drug PrimeC. The agreement includes a substantial upfront payment, funding for Phase 3 clinical trials, milestone payments, and tiered double-digit royalties on annual net sales. The pharmaceutical company will receive exclusive rights to distribute, market, promote, and sell PrimeC in certain key territories, while NeuroSense retains rights in other key markets.

PrimeC is a fixed-dose combination of two FDA-approved drugs, designed to target multiple ALS disease pathways. The company's Phase 2b PARADIGM trial has shown positive safety and efficacy results. The definitive agreement is expected to be finalized in Q1 2025.

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.