Neurosense Therapeutics Ltd Stock Price, News & Analysis

NeuroSense Therapeutics (NASDAQ: NRSN) has issued a shareholder letter highlighting significant developments in their ALS treatment program. The company's Phase 2b PARADIGM study for PrimeC showed promising results, demonstrating a 33% slowing of disease progression (p=0.007) and 58% improvement in survival rates compared to placebo.

The company is preparing for a Phase 3 clinical trial in the second half of 2025, primarily across the US and Europe. In Canada, NeuroSense is pursuing early access through Health Canada's NOC/c pathway, with potential peak annual revenue of $100-150 million in that market.

A binding term sheet signed with a global pharmaceutical company in December 2024 is still under negotiation. The partnership discussions, though taking longer than initially expected due to multi-regional complexity, remain active and constructive.

NeuroSense Therapeutics (NASDAQ: NRSN) has unveiled promising new findings from its Phase 2b PARADIGM clinical trial for PrimeC, its investigational ALS treatment. The data demonstrates PrimeC's significant impact on microRNA (miRNA) modulation, showing a 33% reduction in disease progression and 58% improvement in survival rates.

Key findings include the consistent downregulation of 161 miRNAs in PrimeC-treated patients, while no significant changes were detected in the placebo arm. The treatment specifically downregulated ALS-related miRNAs miR-199 and miR-181, which are associated with disease progression and survival.

The research, presented at the 77th Annual American Academy of Neurology Meeting, was conducted in collaboration with Prof. Noam Shomron of Tel Aviv University and presented by Dr. Jeffrey Rosenfeld of Loma Linda University School of Medicine.

NeuroSense Therapeutics (NRSN) has reported significant clinical progress in 2024, with its lead drug PrimeC showing promising results in a Phase 2b ALS study. The trial demonstrated a 33% slowdown in disease progression (p=0.007) and a 58% improvement in survival rates after 18 months.

The company has aligned Phase 3 study design with FDA and plans initiation in 2025. NeuroSense is pursuing partnership discussions for PrimeC's advancement and plans early commercialization in Canada, with estimated peak annual revenues of $100m-$150m.

Financial results show R&D expenses decreased by 21.9% to $5.7M in 2024, while G&A expenses reduced by 12.5% to $4.2M. The company ended 2024 with $3.4M in cash and reported a net loss of $10.2M.

NeuroSense Therapeutics (NASDAQ: NRSN) will present new data from its Phase 2b trial of PrimeC, a novel ALS treatment, at the 77th Annual American Academy of Neurology Meeting on April 8, 2025, in San Diego.

Two key presentations are scheduled: Dr. Jeremy Shefner will present at 2:24 PM, focusing on PrimeC's safety, efficacy, and target engagement data from an 18-month Phase 2b trial. The results show marked reduction in ALS progression and multiple biomarker endpoints confirming biological activity.

Dr. Jeffrey Rosenfeld will present at 6:15 PM during a late breaker session, discussing microRNA modulation and iron-related pathways in ALS treatment with PrimeC. The presentations highlight PrimeC's potential as a disease-modifying therapy for ALS patients.

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.