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 Therapeutics (NRSN) has scheduled a Nasdaq hearing for November 10, 2026, to present its plan to regain full listing compliance. Its timely appeal of the October 1 Staff Delisting Determination stays suspension and delisting; ordinary shares and warrants are expected to continue trading pending the Panel's decision. Compliance with the $1.00 minimum bid price requirement has been regained. The remaining deficiency is the $35 million minimum market value of listed securities requirement.
NeuroSense intends to present measures to meet that requirement or the alternative $2.5 million stockholders' equity standard and request an exception period. It targets a Health Canada New Drug Submission for PrimeC in ALS in December 2026. A decision on non-dilutive funding for the Phase 3 PARAGON trial is expected in Q1 2027, subject to completion of the ongoing grant review. FDA clearance to initiate PARAGON has been obtained.
NeuroSense Therapeutics (NRSN) regained Nasdaq minimum bid price compliance but faces delisting after failing to meet the minimum market value requirement. An October 1, 2026 determination identified the $35 million market value requirement as the only outstanding listing criterion. The company missed its September 29 deadline after a 180-calendar-day compliance period.
NeuroSense intends to request a hearing and additional time. A timely request stays suspension and delisting filings pending the panel's decision; the company expects its ordinary shares and warrants to continue trading during that process. The panel may grant an exception of up to 180 days from the determination. Following a 1-for-20 reverse share split, the closing bid price remained at least $1.00 for 10 consecutive business days, September 15–28, 2026, closing the bid-price matter.
NeuroSense Therapeutics (NRSN) Chief Financial Officer Or Eisenberg will attend the 5th Annual ROTH Healthcare Opportunities Conference on September 29, 2026.
He will meet with institutional investors in New York City. Expected topics include clinical and regulatory progress with PrimeC, its ALS drug candidate, and the company’s strategy toward potential regulatory approval in Canada, the U.S. and other markets.
NeuroSense (NRSN) reported first-half 2026 results and PrimeC trial progress while targeting a December Canadian regulatory submission.
The Phase 2b PARADIGM study met its primary endpoint in June, showing a statistically significant reduction in extracellular vesicle-associated TDP-43 versus placebo. Long-term follow-up reported in February showed a statistically significant 65% reduction in the risk of death. Estimated median survival was 36.3 months for participants continuously treated with PrimeC, versus 21.4 months for those initially assigned placebo before switching to PrimeC. NeuroSense targets an early December 2026 filing for PrimeC in ALS with Health Canada.
For the six months ended June 30, net loss narrowed to $3.563 million from $4.709 million a year earlier. At June 30, cash was $231,000, current liabilities were $2.999 million, and shareholders' deficit was $2.103 million.
NeuroSense Therapeutics (NRSN) will participate in the H.C. Wainwright 28th Annual Global Investment Conference in New York City, held September 14-16, 2026. The company will present on Tuesday, September 15, 2026, at 4:30 p.m. ET, highlighting recent clinical and regulatory progress for its ALS drug candidate PrimeC and preparations for the Phase 3 PARAGON trial.
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.