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. develops therapies for severe neurodegenerative diseases, led by PrimeC, a proprietary fixed-dose oral extended-release combination of ciprofloxacin and celecoxib. Company news centers on PrimeC clinical and biomarker data in amyotrophic lateral sclerosis, Alzheimer’s disease program updates, regulatory interactions, and scientific publications or conference presentations related to the PARADIGM and PARAGON programs.
Recurring developments also include intellectual-property coverage for the PrimeC composition, including patent grants in Brazil, the United States and Australia, as well as Nasdaq listing compliance notices, shareholder voting matters, capital-structure disclosures, governance updates, material agreements, and operating or financial results.
NeuroSense (NASDAQ: NRSN) detailed a redesigned, capital-efficient development strategy to advance PrimeC toward potential approval in amyotrophic lateral sclerosis (ALS). The three-part plan comprises AI-enabled analysis of PrimeC’s extended-release formulation, a head-to-head active-comparator trial versus edaravone, and an optimized pivotal Phase 3 PARAGON study.
The strategy builds on Phase 2b PARADIGM data and existing FDA clearance to initiate PARAGON, and includes a parallel regulatory path in Canada, where NeuroSense has completed the pre-New Drug Submission process and is targeting a PrimeC New Drug Submission by December 2026.
NeuroSense Therapeutics (NASDAQ: NRSN) detailed its focus on launching PARAGON, a pivotal Phase 3 study of PrimeC in ALS, which has been cleared by the FDA and is expected to enroll about 300 participants, mainly in the U.S. The company emphasized that initiating this large trial requires substantial funding, and securing these resources has taken longer than first anticipated. NeuroSense is pursuing parallel options, including pharmaceutical and strategic partnerships, investors, grants, and other non‑dilutive sources.
The company plans to submit a New Drug Submission for PrimeC to Health Canada in December 2026, based on Phase 2b PARADIGM clinical and biomarker data, and is evaluating additional territories. In April 2026, the CEO and CFO each invested $200,000, alongside a significant existing investor, totaling $600,000. NeuroSense is also addressing Nasdaq continued‑listing deficiencies, proposing shareholder authorization for a potential reverse share split in a 1:4 to 1:40 range as one option to regain minimum bid price compliance, while also seeking an additional compliance period.
NeuroSense (NASDAQ: NRSN) completed the Pre‑New Drug Submission (Pre‑NDS) process with Health Canada for PrimeC, its lead ALS candidate, and is targeting an NDS filing in December 2026. Meeting minutes reflect alignment with Health Canada on the planned content, structure and proposed filing timeline.
Following administrative screening and, if accepted, a standard review of about 300 days, the NDS will be supported by Phase 2b PARADIGM data, including achievement of the primary TDP‑43 biomarker endpoint, long‑term ALSFRS‑R outcomes, an estimated ~15‑month median survival benefit (HR 0.35, p=0.0037), multi‑pathway biomarker findings, and favorable safety and tolerability. NeuroSense is also preparing PARAGON, a confirmatory Phase 3 trial.
NeuroSense Therapeutics (NASDAQ: NRSN) plans to file a New Drug Submission (NDS) with Health Canada for its ALS drug candidate PrimeC, following a constructive Pre-NDS meeting and alignment on the regulatory pathway. The company expects to complete and submit the NDS in the coming months.
According to NeuroSense, the planned submission will be supported by new Phase 2b PARADIGM data, including achievement of the prespecified primary TDP-43 biomarker endpoint (p=0.0421) and a 14.9‑month median survival benefit (HR 0.35; p=0.0037), along with external natural history analyses and additional mechanistic and translational evidence.
NeuroSense (NASDAQ:NRSN) will participate in a Roth Capital Partners KOL webinar titled “A Quest to Outrun ALS” on July 8, 2026, at 11:00 a.m. ET.
Experts will discuss ALS treatment needs, trial endpoints, and NeuroSense’s PrimeC and its Phase 3 PARAGON study.
NeuroSense (NASDAQ:NRSN) reported that its Phase 2b PARADIGM study of PrimeC in ALS met the primary endpoint, showing a statistically significant reduction in neuron-derived TDP-43 versus placebo at Day 180 (p=0.0421), sustained and greater at Day 540 (p<0.001).
According to NeuroSense, PARADIGM also showed statistically significant slowing of ALSFRS-R decline at 12 and 18 months (36.5%, p=0.008; 32.8%, p=0.007), an estimated ~15‑month median survival benefit (HR 0.35, p=0.004), multi-biomarker target engagement, and a favorable safety profile. The company has FDA clearance to initiate its global Phase 3 PARAGON trial.
NeuroSense (NASDAQ:NRSN) reported positive biomarker findings from its Phase 2, randomized, double-blind, placebo-controlled RoAD proof-of-concept study of PrimeC in Alzheimer's disease. Eight participants were enrolled; three completed 12-month follow-up with CSF and plasma sampling at three timepoints.
PrimeC was associated with changes in key AD biomarkers (brain-derived tau, phospho-tau, amyloid-beta 42/40 ratio), misfolded proteins (alpha-synuclein, TDP-43), and markers of oxidative stress and inflammation, consistent with its proposed mechanism. No serious adverse events or new safety signals were identified. NeuroSense plans a future, adequately powered study informed by these data.
NeuroSense Therapeutics (NASDAQ:NRSN) announced that patient community group EverythingALS will host an online event titled “PrimeC - Connecting the Dots” on June 24, 2026, at 7 pm ET.
The session will review emerging data on PrimeC for ALS, led by Prof. Jeffrey Rosenfeld, joined by NeuroSense CEO Alon Ben-Noon, and is aimed at people with ALS, families, caregivers, clinicians, and others interested in ALS research.
NeuroSense (NASDAQ:NRSN) received South Korean Patent No. 10-2969898 covering the composition of PrimeC, its lead ALS candidate. The patent protects formulation, manufacturing process, pharmacokinetics and ALS use in South Korea through 2042.
This grant follows patents in Japan, Brazil, Australia and the US and supports plans to initiate the pivotal Phase 3 PARAGON ALS study, after Phase 2b PARADIGM results that, according to NeuroSense, showed slowed disease progression, biomarker activity and survival benefit.
NeuroSense Therapeutics (NASDAQ: NRSN) received Japanese Patent 7857044 for PrimeC, its lead ALS drug candidate, extending composition and formulation protection in Japan through 2042, subject to standard terms and potential extensions.
The patent covers PrimeC’s unique synchronized delivery of celecoxib and ciprofloxacin, supports a long-term commercialization strategy in a key market, and complements recent U.S., Australia, and Brazil patents. PrimeC is designed to modulate neuroinflammation, iron dysregulation, autophagy, and miRNA pathways, and showed clinical, biomarker, and survival benefits in the Phase 2b PARADIGM study. NeuroSense has FDA clearance and is preparing the pivotal Phase 3 PARAGON trial.