NeuroSense to Hold Pre-NDS Meeting with Health Canada in April 2026

NeuroSense (NASDAQ: NRSN) said it is resuming regulatory activity in Canada for PrimeC in amyotrophic lateral sclerosis (ALS) after a productive discussion with Health Canada.

Rhea-AI Summary

NeuroSense (NASDAQ: NRSN) said it is resuming regulatory activity in Canada for PrimeC in amyotrophic lateral sclerosis (ALS) after a productive discussion with Health Canada.

Health Canada outlined remaining requirements and confirmed NeuroSense's proposed next steps align with the Agency's expectations. The company is preparing for a pre‑NDS meeting currently contemplated in April 2026. With additional clinical data recently generated and further analyses underway, NeuroSense said it anticipates a potential NDS submission by mid‑2026, pending a successful meeting and completion of final submission components.

NeuroSense will provide more details at an investor webinar on December 8, 2025.

Positive

• Health Canada confirmed proposed next steps align with Agency expectations
• Pre‑NDS meeting with Health Canada contemplated for April 2026
• Additional clinical data for PrimeC has been recently generated
• Company anticipates a potential NDS submission by mid‑2026

Negative

• NDS submission is contingent on a successful pre‑NDS meeting and final components

Argus Dec 4 session

-2.44% close to close Open Argus

Details

News Market Reaction – NRSN

On Dec 4, the day this news came out, NRSN closed 2.44% below the previous close.

Data tracked by StockTitan Argus for the Dec 4 session.

Key Figures

PARAGON participants: 300 participants PARAGON power: >95% power RoAD sample size: 8 patients +5 more

PARAGON participants

300 participants

Planned pivotal Phase 3 ALS trial, randomized 2:1 (PrimeC:placebo)

PARAGON power

>95% power

Primary endpoint powering in pivotal Phase 3 PARAGON ALS trial

RoAD sample size

8 patients

Phase 2 RoAD Alzheimer’s proof-of-concept study database lock

ALS survival PrimeC

15 of 30 alive

Limited survival outcomes for participants originally on PrimeC

ALS survival placebo

1 of 14 alive (~7%)

Limited survival outcomes for participants originally on placebo

Registered shares

333,334 ordinary shares

Form F-3 resale registration for selling shareholder

Private placement price

$1.50 per share

September 2025 private placement for gross proceeds of ~$0.5M

Shares outstanding

29,550,970 shares

Ordinary shares outstanding as of Oct 27, 2025

Historical Context

5 past events · Latest: Dec 04

5 events

1. Dec 04

   Regulatory update

   24h Move

   -3.5%

   Resumed Canadian regulatory path and pre‑NDS meeting timing for PrimeC in ALS.

2. Nov 24

   Phase 3 clearance

   24h Move

   -3.6%

   FDA authorized pivotal Phase 3 PARAGON trial of PrimeC in ALS.

3. Nov 03

   Investor webinar announcement

   24h Move

   -3.6%

   Announced Dec 8 webinar on Phase 3 PARAGON, Canada plans and Alzheimer’s.

4. Oct 06

   Alzheimer's biomarker data

   24h Move

   -6.4%

   Phase 2b biomarker data showed significant reductions in Alzheimer’s-linked microRNAs.

5. Sep 10

   Alzheimer's clinical signal

   24h Move

   +16.2%

   Phase 2 RoAD trial showed enhanced neuroplasticity with no treatment-related toxicity.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

amyotrophic lateral sclerosis, Phase 3, double-blind, placebo-controlled, +4 more

8 terms

amyotrophic lateral sclerosis medical

"for PrimeC in amyotrophic lateral sclerosis (ALS)."

A progressive disease in which nerve cells that control voluntary muscles gradually fail, leading to loss of movement, speech and eventually breathing — like an electrical wiring system in the body slowly shorting out. It matters to investors because there are few effective treatments, so clinical trial results, regulatory approvals, new therapies or diagnostics can rapidly change patient care, market opportunity and company valuations.

Phase 3 medical

"pivotal Phase 3 trial PARAGON evaluating PrimeC in amyotrophic lateral sclerosis"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

double-blind medical

"global, double-blind, 12-month, placebo-controlled study with 300 participants"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"double-blind, 12-month, placebo-controlled study with 300 participants randomized"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open-label extension medical

"participants randomized 2:1 (PrimeC:placebo), an open-label extension, an adaptive design"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

adaptive design medical

"an open-label extension, an adaptive design with interim analyses"

Adaptive design is a way to run clinical trials that lets researchers change aspects of the study—such as dose, sample size, or which patient groups are studied—based on data gathered while the trial is ongoing, without starting over. For investors, it matters because this flexibility can shorten development time, reduce costs, and increase the chance of finding a successful outcome, similar to steering a ship toward calmer waters as conditions change.

Form F-3 regulatory

"filed a Form F-3 to register 333,334 ordinary shares for resale"

Form F-3 is a U.S. securities filing that lets eligible foreign companies pre-register and then quickly sell shares or other securities to raise money, because they already meet ongoing reporting and size tests. For investors it signals that the company is up-to-date with regulatory disclosure and has an efficient way to issue new securities — similar to a pre-approved credit line — which can mean faster capital raises but also potential dilution of existing holdings.

Form S-8 regulatory

"references to Form S-8 and multiple Form F-3 filings to be part of the report"

A Form S-8 is a U.S. Securities and Exchange Commission registration that lets a public company set aside shares for employee benefit plans and stock-based compensation. Think of it as opening a dedicated account that authorizes the company to issue or reserve stock for workers and directors; it matters to investors because it enables share dilution when those awards are granted or exercised and signals how management is compensated and incentivized.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada ("Agency"), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).

After outlining the remaining requirements, Health Canada confirmed that NeuroSense's proposed next steps align with the Agency's expectations. With additional clinical data recently generated and further supportive analyses underway, NeuroSense is now preparing for a pre-NDS meeting with Health Canada currently contemplated in April 2026.

Pending a successful outcome of this meeting and completion of the final submission components, the Company currently anticipates a potential NDS submission by mid-2026.

"This positive engagement reinforces our confidence in the regulatory pathway in Canada," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS."

Additional details regarding the Canadian submission and contemplated timelines will be provided during NeuroSense's upcoming investor webinar on December 8^th, 2025. Registration for the webinar is available here.

About ALS

Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and Alzheimer's Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations, and include statements regarding the timing of a pre-NDA meeting with Health Canada and the timing of a potential NDS submission, and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the pre-NDA meeting with Health Canada will be delayed or not occur; that the potential NDS submission will be delayed or not occur; Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When is NeuroSense (NRSN) scheduled to meet Health Canada for the pre‑NDS?

The company said a pre‑NDS meeting is currently contemplated in April 2026.

What is NeuroSense's (NRSN) target timeline for an NDS submission in Canada?

NeuroSense currently anticipates a potential NDS submission by mid‑2026, pending the meeting and final components.

What regulatory feedback did NeuroSense (NRSN) receive from Health Canada?

Health Canada outlined the remaining requirements and confirmed NeuroSense's proposed next steps align with Agency expectations.

Will NeuroSense (NRSN) share more details about the Canadian submission timeline?

Yes. Additional details will be provided during NeuroSense's investor webinar on December 8, 2025.

Does NeuroSense (NRSN) have new clinical data supporting PrimeC's Canadian submission?

The company reported that additional clinical data was recently generated and further supportive analyses are underway.