PrimeC Long-Term Survival Data to Be Presented at a Leading ALS Scientific Conference

Rhea-AI Summary

NeuroSense (NASDAQ: NRSN) will present long-term survival data from the Phase 2b PARADIGM trial of PrimeC at the MDA Clinical & Scientific Conference on March 9, 2026. The analysis showed a 65% reduction in risk of death (HR 0.35; p=0.0037) and a >14-month median survival benefit (36.3 vs. 21.4 months; log-rank p=0.0218).

The randomized, double-blind, placebo-controlled study enrolled 68 participants (2:1 randomization) with a six-month double-blind period followed by an open-label extension; safety was described as favorable.

Positive

• Survival benefit: hazard ratio 0.35 (65% risk reduction)
• Median survival +14.9 months (36.3 vs. 21.4 months)
• Statistically significant results: Cox p=0.0037; log-rank p=0.0218
• Randomized, double-blind, placebo-controlled Phase 2b design

Negative

• Small sample size: 68 participants limits generalizability
• Long-term outcomes influenced by open-label extension phase
• Phase 3 study still required for regulatory approval

Key Figures

Risk reduction: 65% reduction in risk of death Hazard ratio: 0.35 P-value (hazard model): p=0.0037 +5 more

8 metrics

Risk reduction 65% reduction in risk of death Cox proportional hazards model, Phase 2b PARADIGM ALS trial

Hazard ratio 0.35 Adjusted for baseline risk factors in survival analysis

P-value (hazard model) p=0.0037 Statistical significance for survival benefit with PrimeC

Median survival (PrimeC) 36.3 months Kaplan–Meier estimate from date of randomization

Median survival (placebo) 21.4 months Kaplan–Meier estimate for initial placebo group

P-value (log-rank) p=0.0218 Log-rank test comparing survival curves

Sample size 68 people Participants in PARADIGM Phase 2b ALS trial

Treatment duration 18 months Period over which safety and progression were assessed

Market Reality Check

Price: $0.8660 Vol: Volume 67,701 vs 20-day a...

low vol

$0.8660 Last Close

Volume Volume 67,701 vs 20-day average 157,553 (relative volume 0.43). low

Technical Price 0.866 trades below 200-day MA at 1.28, and 66.69% below 52-week high.

Peers on Argus

NRSN showed a modest 1.38% gain while peers were mixed: ALLR up 18.1%, KZR up 3....

3 Up 1 Down

NRSN showed a modest 1.38% gain while peers were mixed: ALLR up 18.1%, KZR up 3.58%, TENX down 9.1%, DARE down 3.16%, ITRM roughly flat at 0.42%. Momentum scanner peers (NEUP, OKUR, ALLR) were up, RVPH was down, supporting a stock-specific rather than sector-wide move.

Historical Context

5 past events · Latest: Feb 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 18	ALS survival data	Positive	-14.7%	Reported 65% death-risk reduction and >14-month median survival benefit in ALS.
Feb 09	Patent grant	Positive	+8.5%	Australian patent granted extending PrimeC composition protection through October 2042.
Jan 21	Alzheimer’s patent	Positive	-5.2%	U.S. patent granted for PrimeC in Alzheimer’s disease with protection to 2043.
Jan 08	SAB appointment	Positive	+12.4%	Renowned Alzheimer’s expert joined SAB as company highlighted favorable RoAD safety data.
Dec 22	Alzheimer’s safety data	Positive	+3.8%	Phase 2 Alzheimer’s study confirmed favorable tolerability with no serious adverse events.

Pattern Detected

Positive clinical and IP news has produced mixed reactions, with both strong rallies and notable selloffs, indicating inconsistent alignment between favorable milestones and short-term price moves.

Recent Company History

Over recent months, NeuroSense reported multiple positive updates: extended PARADIGM Phase 2b survival data with a 65% death-risk reduction and >14-month median survival gain, new Australian and U.S. patents extending PrimeC protection into 2042–2043, and favorable Alzheimer’s safety outcomes. Price reactions ranged from a 14.69% drop to a 12.43% rise, showing that even strong clinical and IP news has not translated consistently into upside, framing today’s conference-focused survival-data announcement within a volatile response pattern.

Regulatory & Risk Context

Active S-3 Shelf · $150,000,000

Shelf Active

Active S-3 Shelf Registration 2026-01-29

$150,000,000 registered capacity

On 2026-01-29, the company filed a Form F-3 shelf to offer up to $150,000,000 in securities and established an ATM program of up to $6,525,000. The filing carries forward $85,778,066 of unsold prior securities and notes substantial doubt about the company’s ability to continue as a going concern, underscoring reliance on future financings under this shelf and ATM.

Market Pulse Summary

This announcement highlights long-term survival findings from the PARADIGM Phase 2b ALS trial, inclu...

Analysis

This announcement highlights long-term survival findings from the PARADIGM Phase 2b ALS trial, including a 65% reduction in death risk and median survival of 36.3 vs 21.4 months. Presented at a major ALS-focused conference, the data strengthen the case for advancing PrimeC toward Phase 3. Investors may monitor upcoming regulatory interactions, design of the pivotal study, and how the company utilizes its $150,000,000 shelf registration to support ongoing development.

Key Terms

cox proportional hazards model, hazard ratio, kaplan–meier survival estimates, randomized, double-blind, placebo-controlled, +4 more

8 terms

cox proportional hazards model medical

"The survival analysis using a Cox proportional hazards model demonstrated benefit"

A cox proportional hazards model is a statistical tool used to compare how different factors affect the timing of an event, such as disease progression or product failure, while accounting for varying follow-up times. Think of it as comparing lanes on a highway to see which drivers are more likely to reach an exit sooner, holding other conditions steady. Investors use it to judge how treatments, risks or company actions change the likelihood and timing of key outcomes that affect value and regulatory decisions.

hazard ratio medical

"65% reduction in risk of death (hazard ratio: 0.35; p=0.0037)"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

kaplan–meier survival estimates medical

"according to Kaplan–Meier survival estimates."

Kaplan–Meier survival estimates are a statistical curve that shows the probability of an event (such as remaining alive or free from disease progression) over time, taking into account participants who leave a study early. For investors, these curves translate clinical trial results into a clear picture of how long a treatment’s benefits last and the likelihood of regulatory or commercial success, helping assess future revenue and risk much like a timeline showing how many people remain in a crowd as time passes.

randomized, double-blind, placebo-controlled medical

"PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

open-label extension medical

"double-blind period, followed by an open-label extension phase."

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.

phase 2b medical

"long-term survival data from its Phase 2b PARADIGM trial of PrimeC"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

phase 3 study medical

"preparations for the Phase 3 study."

A phase 3 study is the large-scale clinical trial that tests whether a new drug or medical treatment actually works and is safe in a broad group of patients, typically after earlier smaller tests. Investors watch these studies like a final dress rehearsal because their successful completion is often required for regulatory approval and market access; positive or negative results can sharply change a company’s future sales prospects and stock value.

miRNA medical

"findings showing that PrimeC regulates iron metabolism and miRNA in ALS"

MicroRNA (miRNA) are short, naturally occurring RNA molecules that control how much of a given protein a cell makes, acting like tiny switches or volume knobs that turn gene activity up or down. They matter to investors because miRNA patterns can signal disease, be used as biomarkers for diagnostics, or become targets for new therapies, all of which influence the value and risk of biotech and healthcare investments. Tracking advances in miRNA research helps evaluate potential market size and clinical feasibility for related products.

AI-generated analysis. Not financial advice.

CAMBRIDGE, Mass., March 9, 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 that the recently reported long-term survival data from its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) will be presented at a leading scientific conference on March 9, 2026.

The survival analysis using a Cox proportional hazards model  demonstrated benefit for PrimeC with a statistically significant 65% reduction in risk of death (hazard ratio: 0.35; p=0.0037) after adjusting for baseline risk factors and a greater than 14-month median survival benefit, calculated from the date of randomization (36.3 months vs. 21.4 months; log-rank p=0.0218) according to Kaplan–Meier survival estimates. The data will be presented at The Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 9, 2026) during the 'Advancing ALS Therapeutics: Targets, Tools, and Trial Readiness' session.

The data will be presented by Dr. Jinsy Andrews, a recognized leader in ALS clinical research and a member of NeuroSense Scientific Advisory Board (SAB).

"These long-term survival findings from the Phase 2b randomized ALS study, PARADIGM,  represent compelling evidence of a survival benefits," said Dr. Jinsy Andrews. "The favorable safety profile, the long-term survival data, together with recent findings showing that PrimeC regulates iron metabolism and miRNA in ALS, supporting target engagement, strongly reinforce the continued development of PrimeC in ALS. I look forward to sharing these data with the broader scientific community."    

The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study evaluating PrimeC in 68 people living with ALS. Participants were randomized 2:1 to receive PrimeC or placebo during the six-month double-blind period, followed by an open-label extension phase. Baseline characteristics were well-balanced between the two groups. Previously reported results demonstrated statistically significant slowing of disease progression, along with favorable safety and tolerability over 18 months of treatment.

The newly analyzed long-term survival data further strengthen the overall clinical dataset supporting PrimeC and provide additional context as NeuroSense advances regulatory engagement and preparations for the Phase 3 study.

NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.

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.

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.

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View original content:https://www.prnewswire.com/news-releases/primec-long-term-survival-data-to-be-presented-at-a-leading-als-scientific-conference-302708280.html

SOURCE NeuroSense

FAQ

What did NeuroSense (NRSN) report about PrimeC survival data on March 9, 2026?

PrimeC showed a statistically significant survival benefit with HR 0.35 and p=0.0037. According to the company, Kaplan–Meier estimates indicated a >14-month median survival advantage (36.3 vs. 21.4 months; log-rank p=0.0218).

How large was the PARADIGM Phase 2b trial for PrimeC (NRSN) and what was the design?

PARADIGM enrolled 68 people living with ALS and used 2:1 randomization. According to the company, it was randomized, double-blind, placebo-controlled with a six-month double-blind period and open-label extension.

Were PrimeC safety and tolerability reported in the Phase 2b PARADIGM data for NRSN?

Yes — safety was described as favorable alongside efficacy findings. According to the company, prior 18-month results showed favorable tolerability and no new safety signals in the trial dataset.

What are the statistical highlights of PrimeC survival analysis presented by NRSN?

The Cox model showed HR 0.35 (65% reduction) with p=0.0037 and Kaplan–Meier median survival 36.3 vs. 21.4 months. According to the company, the log-rank test p=0.0218 supports the survival difference.

What are the next steps for PrimeC development after the March 9, 2026 presentation by NRSN?

NeuroSense plans continued regulatory engagement and Phase 3 preparations. According to the company, the long-term survival data will inform regulatory discussions and design of a pivotal Phase 3 study.