PrimeC boosts ALS survival in NeuroSense (NRSN) Phase 2b follow-up data
Rhea-AI Filing Summary
NeuroSense Therapeutics reported new long-term survival data from its completed Phase 2b trial of PrimeC in amyotrophic lateral sclerosis (ALS). Patients treated continuously with PrimeC showed an estimated median survival of 36.3 months versus 21.4 months for those initially on placebo, an improvement of over 14 months and about a 70% increase in median survival. A log-rank test showed statistically significant separation between treatment arms (p = 0.0218), and a Cox model associated PrimeC with a 65% reduction in risk of death versus placebo (hazard ratio 0.35; 95% CI: 0.17–0.71; p = 0.0037). The randomized, double-blind, placebo-controlled trial in 68 ALS patients had previously demonstrated slowed disease progression and favorable safety. NeuroSense believes these survival results strengthen the case for advancing PrimeC into pivotal late-stage development.
Positive
- PrimeC survival benefit in ALS: Extended follow-up from the Phase 2b trial shows an estimated median survival of 36.3 months for continuously treated patients versus 21.4 months for those initially on placebo, with a reported 65% reduction in risk of death (hazard ratio 0.35; p = 0.0037).
Negative
- None.
Insights
PrimeC shows statistically significant ALS survival gains, potentially reshaping its late-stage outlook.
The new Phase 2b follow-up data for PrimeC in ALS report an estimated median survival of 36.3 months for continuously treated patients versus 21.4 months for those initially on placebo. That more than 14‑month difference and roughly 70% higher median survival are clinically substantial in a disease with typically rapid decline.
Statistical robustness appears supported by a log-rank p value of 0.0218 and a Cox model hazard ratio of 0.35 (95% CI: 0.17–0.71; p = 0.0037), indicating a reported
NeuroSense states that it is engaging with regulators and views these survival findings as strengthening the clinical and regulatory foundation as PrimeC moves toward pivotal late‑stage development. Actual outcomes will depend on future regulatory feedback and results from later, larger trials, as implied by the company’s forward‑looking statements and risk disclosures.
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 February 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 February 18, 2026, NeuroSense Therapeutics Ltd. issued a press release announcing the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis (ALS). A copy of the press release is furnished herewith as Exhibit 99.1.
This Report on Form 6-K (other than the sixth paragraph in Exhibit 99.1) is 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.
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Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated February 18, 2026 |
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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: February 18, 2026 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
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Exhibit 99.1
NeuroSense Announces Statistically Significant 65% Reduction in Risk of Death and Greater than 14-Month Median Survival Benefit with PrimeC in ALS
CAMBRIDGE, Mass., Feb. 18, 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 the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis (ALS).
The updated analysis, based on extended follow-up, demonstrates a clinically meaningful and statistically significant improvement in overall survival for patients treated with PrimeC, compared to those initially assigned to placebo.
According to Kaplan–Meier survival estimates, patients who received PrimeC continuously during both the double-blind and open-label phases achieved an estimated median survival of 36.3 months, compared to 21.4 months for patients initially assigned to placebo during the double-blind phase and crossing over to active treatment during the open label extension. This represents over 14-month improvement and approximately a 70% increase in median survival. The survival benefit was sustained over time, with consistent separation between treatment arms throughout the follow-up period.
A log-rank test comparing survival curves demonstrated statistical significance (p = 0.0218).
Further analysis using a Cox proportional hazards model showed that PrimeC treatment was associated with a 65% reduction in the risk of death compared to placebo (hazard ratio: 0.35; 95% CI: 0.17–0.71; p = 0.0037), after adjusting for baseline risk factors.
“The long-term survival data further validate the magnitude and durability of PrimeC’s effect in ALS and reinforce its potential as a disease-modifying therapy,” said Alon Ben-Noon, CEO of NeuroSense. “A 65% reduction in the risk of death and a statistically significant extension in median survival of over 14 months represent a clinically meaningful benefit of notable magnitude in ALS. We believe these findings substantially strengthen the clinical and regulatory foundation as we advance toward late-stage development.”
The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of PrimeC in 68 people living with ALS. Participants were administered PrimeC or placebo at a 2:1 ratio, respectively, for the six-month double-blind part. NeuroSense previously reported positive top-line results from the trial, including statistically significant slowing of disease progression and favorable safety and tolerability. The newly reported survival findings represent additional meaningful data generated from the same completed study, further enhancing the overall data package supporting PrimeC.
NeuroSense continues to engage with regulatory authorities regarding the advancement of PrimeC into pivotal late-stage development and believes these findings add important long-term clinical context to previously reported efficacy results.
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.
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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. 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 timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 uncertainty regarding outcomes and the timing of current and future clinical trials; the risk the 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 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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183
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FAQ
What did NeuroSense Therapeutics (NRSN) report about PrimeC in ALS?
How large was the survival benefit seen with PrimeC in NeuroSense’s Phase 2b ALS trial?
How statistically strong are NeuroSense’s new PrimeC ALS survival results?
What was the design and size of NeuroSense’s Phase 2b trial of PrimeC in ALS?
How do the new survival data fit with earlier PrimeC Phase 2b results from NeuroSense (NRSN)?
What are NeuroSense Therapeutics’ next steps for PrimeC after these ALS survival findings?
What is PrimeC and how is it designed to treat ALS according to NeuroSense?
Filing Exhibits & Attachments
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