NeuroSense Therapeutics (NASDAQ: NRSN) eyes Canada NDS for ALS drug

Rhea-AI Filing Summary

NeuroSense Therapeutics plans to file a New Drug Submission with Health Canada for its lead candidate PrimeC to treat amyotrophic lateral sclerosis, following a constructive Pre-New Drug Submission meeting in which regulators reviewed updated Phase 2b data.

The company presented achievement of the trial’s prespecified primary TDP-43 biomarker endpoint (p=0.0421) and long-term survival results, including a 14.9-month median survival benefit with PrimeC (hazard ratio 0.35, p=0.0037), alongside external natural history analyses and mechanistic and translational data. NeuroSense describes this regulatory interaction as an important milestone and intends to continue working with Health Canada while preparing the filing. PrimeC is an oral fixed-dose combination of ciprofloxacin and celecoxib, and the FDA has cleared a pivotal Phase 3 ALS trial (PARAGON) expected to enroll approximately 300 participants.

Positive

• Phase 2b clinical results for PrimeC in ALS showed a 14.9-month median survival benefit with a hazard ratio of 0.35 (p=0.0037), alongside achievement of the prespecified primary TDP-43 biomarker endpoint (p=0.0421), supporting NeuroSense’s planned New Drug Submission to Health Canada.

Negative

• None.

Key Figures

Median survival benefit: 14.9-month Hazard ratio for survival: 0.35 Primary TDP-43 endpoint p-value: p=0.0421 +5 more

8 metrics

Median survival benefit 14.9-month Median survival benefit with PrimeC in Phase 2b ALS study

Hazard ratio for survival 0.35 Hazard ratio associated with PrimeC long-term survival outcome in Phase 2b

Primary TDP-43 endpoint p-value p=0.0421 P-value for prespecified primary TDP-43 biomarker endpoint achieved in Phase 2b

Survival outcome p-value p=0.0037 P-value for long-term survival benefit observed with PrimeC

Planned Phase 3 enrollment approximately 300 participants Expected enrollment in pivotal Phase 3 PARAGON ALS trial

ALS survival after diagnosis 2-5 years Typical time from ALS diagnosis to complete paralysis and death

Annual U.S. ALS diagnoses more than 5,000 people Estimated new ALS cases per year in the United States

Annual ALS disease burden $1 billion Estimated yearly economic burden of ALS in the United States

Key Terms

New Drug Submission (NDS), Pre-New Drug Submission (Pre-NDS), TDP-43 biomarker endpoint, Phase 2b clinical program, +2 more

6 terms

New Drug Submission (NDS) regulatory

"intends to proceed with the filing of a New Drug Submission (NDS) to Health Canada"

A new drug submission (NDS) is a formal application filed with a health regulator asking for permission to market a new medicine, and it includes the data, safety and effectiveness evidence, and manufacturing details needed for review. For investors, the NDS outcome and its review timeline drive whether and when a drug can generate revenue, so acceptance, delay, or rejection materially affects a drugmaker’s future sales prospects and risk—like a building permit deciding if a project can move forward.

Pre-New Drug Submission (Pre-NDS) regulatory

"following a constructive Pre-New Drug Submission (Pre-NDS) meeting with the Agency"

TDP-43 biomarker endpoint medical

"including achievement of the study’s prespecified primary TDP-43 biomarker endpoint (p=0.0421)"

Phase 2b clinical program medical

"meeting was held following the generation of substantial additional evidence from the Phase 2b clinical program"

pivotal Phase 3 clinical trial medical

"clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON)"

A pivotal phase 3 clinical trial is the large, late-stage study designed to show whether an experimental drug or medical treatment is safe and effective enough for regulatory approval. Think of it as the final, official exam or road test: its results largely determine whether a product can be sold, so investors watch these outcomes closely because they strongly affect the likelihood of approval, potential market size, future revenues, and company valuation.

amyotrophic lateral sclerosis (ALS) medical

"for the treatment of amyotrophic lateral sclerosis (ALS)"

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that damages nerve cells responsible for controlling voluntary muscles, leading to muscle weakness, loss of movement, and eventually paralysis. It matters to investors because health-related research, treatments, and biotech companies working on ALS can influence stock markets and create opportunities or risks within the healthcare sector.

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FAQ

What did NeuroSense Therapeutics (NRSN) announce in this 6-K?

NeuroSense Therapeutics announced it plans to file a New Drug Submission with Health Canada for its ALS candidate PrimeC, following a constructive Pre-NDS meeting where updated Phase 2b clinical, biomarker and survival data were presented to the agency.

What clinical data support NeuroSense (NRSN) moving PrimeC toward an NDS in Canada?

NeuroSense reported PrimeC achieved the prespecified primary TDP-43 biomarker endpoint (p=0.0421) and showed a 14.9-month median survival benefit with a hazard ratio of 0.35 (p=0.0037) in its Phase 2b ALS program, plus additional mechanistic and translational evidence.

What is PrimeC, NeuroSense Therapeutics’ (NRSN) lead drug candidate?

PrimeC is an oral, extended-release fixed-dose combination of ciprofloxacin and celecoxib, designed to target multiple ALS and Alzheimer’s disease pathways, including neuroinflammation, oxidative stress, iron accumulation and impaired RNA regulation, with the goal of slowing disease progression.

What future clinical plans for PrimeC did NeuroSense (NRSN) describe?

NeuroSense stated that the FDA has cleared a pivotal Phase 3 trial (PARAGON) of PrimeC in ALS, expected to enroll approximately 300 participants, primarily in the United States, in addition to preparing the New Drug Submission to Health Canada.

How severe is ALS according to NeuroSense’s (NRSN) disclosure?

NeuroSense describes ALS as an incurable neurodegenerative disease causing paralysis and death within 2–5 years of diagnosis, with more than 5,000 new U.S. cases annually and an estimated annual disease burden of $1 billion, and cases projected to rise 24% by 2040 in the U.S. and EU.

What regulatory milestone with Health Canada did NeuroSense (NRSN) report?

NeuroSense reported a constructive Pre-New Drug Submission meeting with Health Canada, where it aligned on the NDS pathway for PrimeC in ALS and presented expanded Phase 2b, biomarker, survival and mechanistic data that will form part of the planned submission package.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of July 2026

Commission File Number: 001-41084

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-7996183
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒    Form 40-F ☐

Explanatory Note

On July 22, 2026, NeuroSense Therapeutics Ltd. issued a press release entitled “NeuroSense Advances PrimeC Toward New Drug Submission to Health Canada for ALS.” A copy of the press release is furnished herewith as Exhibit 99.1.

The first two paragraphs of the press release attached hereto as Exhibit 99.1 are hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480 and 333-289658) and Form F-3 (File No. 333-269306, 333-260338, 333-283656, 333-284051, 333-291122 and 333-293060) to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

1

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated July 22, 2026

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	NeuroSense Therapeutics Ltd.
Date: July 22, 2026	By:	/s/ Alon Ben-Noon
		Alon Ben-Noon
		Chief Executive Officer

3

Exhibit 99.1

NeuroSense Advances PrimeC Toward New Drug Submission to Health Canada for ALS

The planned submission follows alignment with Health Canada on the NDS pathway and is supported by additional PARADIGM data, including a survival benefit and consistent effects across PrimeC’s multi-pathway biomarker program

CAMBRIDGE, Mass., July 22, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced it intends to proceed with the filing of a New Drug Submission (NDS) to Health Canada (the “Agency”) for PrimeC for the treatment of amyotrophic lateral sclerosis (ALS), following a constructive Pre-New Drug Submission (“Pre-NDS”) meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months.

 

The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study’s prespecified primary TDP-43 biomarker endpoint (p=0.0421), long-term survival (14.9-month median survival benefit, HR 0.35 and p=0.0037), external natural history analyses, and additional mechanistic and translational data generated since the Company’s initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC’s potential in ALS.

“This marks an important milestone in our regulatory strategy for PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “The additional evidence generated through the PARADIGM program - from achievement of the primary TDP-43 biomarker endpoint to the meaningful long-term survival outcome - has significantly strengthened our planned submission package and reinforces our confidence in PrimeC’s potential to address the substantial unmet need faced by people living with ALS. We appreciate Health Canada’s constructive engagement throughout the Pre-NDS process and look forward to completing our submission.”

NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, supporting meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. and representing a potentially important advance in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

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.

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 AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

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.

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 including statements regarding regulatory plans and the timing thereof in Canada and the future development of PrimceC. 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 are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the potential of PrimeC. 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 potential NDS submission will be delayed or not occur; the uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; 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 March 31, 2026 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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

For further information: Email: info@neurosense-tx.com | Tel: +972 (0)9 799 6183

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED JULY 22, 2026 13.0 KB