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. (NASDAQ: NRSN) is a clinical-stage biotechnology company developing novel treatments for severe neurodegenerative diseases, with a primary focus on amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. Its news flow centers on the clinical and regulatory progress of its lead drug candidate, PrimeC, a novel extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, in a fixed dose designed to target multiple disease mechanisms.
News updates for NRSN commonly cover milestones in ALS and Alzheimer’s clinical programs. These include Phase 2 and Phase 2b trial readouts, such as the PARADIGM study in ALS and the RoAD proof-of-concept study in Alzheimer’s disease, along with biomarker analyses that the company uses to interpret treatment effects. Press releases also highlight safety and tolerability findings, including reports of favorable safety profiles and absence of new or unexpected safety signals in clinical studies.
Investors and observers can expect coverage of regulatory interactions, such as FDA clearance to initiate a pivotal Phase 3 trial of PrimeC in ALS, database lock announcements for Alzheimer’s trials, and updates on planned submissions to agencies like Health Canada. Corporate and financing developments, including private placements of ordinary shares and business updates, are also frequent topics.
This news page aggregates these company-issued announcements, SEC-related communications and other public disclosures about NeuroSense’s progress. It is useful for readers who want to follow NRSN’s clinical trial milestones, biomarker-driven research updates, regulatory steps and capital-raising activities as the company advances PrimeC in ALS and Alzheimer’s disease.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) reported its Q3 2022 financial results, highlighting notable milestones in its Phase 2b ALS study. The FDA accepted NeuroSense's IND, allowing for patient enrollment in the U.S. and Italy. As of September 30, 2022, the company had $8.4 million in cash and short-term deposits, sufficient to fund operations into Q4 2023. R&D expenses rose to $4.87 million from $3.04 million year-over-year, while general and administrative expenses increased to $5.30 million. The company expects steady expenses through 2022.
NeuroSense Therapeutics (NASDAQ: NRSN) has received approval from Italy's Medicines Agency (AIFA) to enroll patients in its Phase 2b clinical trial, PARADIGM, for ALS treatment with lead candidate PrimeC. This trial is also ongoing in Israel and has FDA clearance for recruitment in the U.S. The study will randomize 69 ALS patients to receive either PrimeC or placebo, assessing efficacy and safety over 6 months. PrimeC aims to mitigate ALS's motor neuron degeneration using a novel drug combination. This milestone expands patient access to potentially beneficial treatment options.
NeuroSense Therapeutics has received FDA clearance to enroll patients in the U.S. for its Phase 2b PARADIGM study of PrimeC, a novel combination therapy for ALS. Following successful pharmacokinetic studies, PrimeC targets key ALS mechanisms and includes two FDA-approved drugs. The study aims to enroll 69 patients to assess PrimeC's efficacy, safety, and tolerability. NeuroSense anticipates starting U.S. enrollments soon and aims to complete enrollment and announce results by mid-2023, leveraging its Orphan Drug Designation from the FDA and EMA.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced its participation in three major conferences focusing on neurodegenerative diseases. Key presentations include:
- At the NEALS Meeting (Nov 1-3, Clearwater Beach, FL), Dr. Ferenc Tracik will discuss the Phase IIb PARADIGM study and Dr. Shiran Zimri will present biomarker research.
- During Neuroscience 2022 (Nov 12-16, San Diego, CA), Dr. Zimri will explore PrimeC's potential for ALS treatment.
- The International Symposium on ALS/MND (Dec 6-9, Virtual) will feature Dr. Zimri presenting NeuroSense's clinical plans.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) has announced its participation in the BIO-Europe Partnering Conference taking place from October 24-26, 2022, in Lepzing, Germany. The company's VP of Business Development, Nedira Salzman Frenkel, will engage with potential partners in the CNS space to explore collaboration opportunities. Concurrently, Dr. Niva Russek Blum, VP Discovery & IP Generator, will assess assets from various institutions focusing on neurological conditions. NeuroSense is dedicated to developing therapies for severe neurodegenerative diseases, such as ALS and Alzheimer's.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) provided a Q3 update, highlighting advancements in its Phase IIb study for PrimeC, a drug designed for ALS. The company achieved enrollment milestones with over one-third of patients enrolled and aims for completion by late 2022. They also established collaborations to enhance ALS diagnostics and presented significant findings at key scientific conferences. With over $9 million in cash, NeuroSense is positioned to continue its clinical development. CEO Alon Ben-Noon acknowledged ALS community advancements and expressed gratitude to stakeholders.
NeuroSense Therapeutics (NASDAQ: NRSN) is set to participate in the Nasdaq Opening Bell Ceremony on October 13, 2022. CEO Alon Ben Noon will lead the event, celebrating the company's achievements since going public. NeuroSense will also host The ALS Combination Therapy Summit, discussing critical ALS topics and featuring prominent thought leaders. The company’s Phase IIb PARADIGM trial for its lead drug candidate, PrimeC, is currently enrolling patients, with top-line data expected mid-2023. The ALS disease burden is significant, with over 5,000 new cases annually in the U.S.
NeuroSense Therapeutics (NASDAQ: NRSN) announced participation in the Cantor Fitzgerald Neurology and Psychiatry Conference on October 6-7, 2022, in San Francisco. CEO Alon Ben-Noon will join a panel on ALS, while Prof. Jeremy Shefner will be a keynote speaker. The company's lead drug, PrimeC, is in a Phase IIb trial aimed at treating ALS, with topline data expected in mid-2023. PrimeC has already demonstrated safety and efficacy in previous trials, and has received Orphan Drug Designation from the FDA and EMA.
NeuroSense Therapeutics (NRSN) announced positive results from a multi-dose pharmacokinetic (PK) study of its lead drug candidate PrimeC, targeting amyotrophic lateral sclerosis (ALS). The study demonstrated PrimeC's extended release properties and favorable safety profile, supporting its ongoing Phase IIb PARADIGM trial. PrimeC, a combination of celecoxib and ciprofloxacin, has shown effective simultaneous release and bioavailability, reinforcing its dosing regimen. The company anticipates pivotal Phase III trial design to align with FDA requirements based on these findings.
NeuroSense Therapeutics (Nasdaq: NRSN) announced its participation in two conferences focused on amyotrophic lateral sclerosis (ALS). Presentations will cover the efficacy of PrimeC, its lead drug candidate, in the Phase IIb PARADIGM trial, with primary endpoints including ALS biomarkers. The TRICALS Consortium Masterclass in the Netherlands (September 28-30) and ALS ONE's 5th Annual Symposium (October 6-7, 11) will feature updates from the company's experts. Topline results from the trial are expected in H1 2023.