NeuroSense Announces Statistically Significant 65% Reduction in Risk of Death and Greater than 14-Month Median Survival Benefit with PrimeC in ALS

Rhea-AI Summary

NeuroSense (NASDAQ: NRSN) reported extended PARADIGM Phase 2b survival data showing a median survival of 36.3 months with continuous PrimeC versus 21.4 months for initial placebo, an improvement of over 14 months (~70% increase).

Adjusted analysis showed a 65% reduction in risk of death (HR 0.35; 95% CI 0.17–0.71; p=0.0037) and a statistically significant log-rank p=0.0218. The randomized 68-patient trial included a 2:1 active:placebo double-blind period and an open-label extension; company engagement with regulators continues.

Positive

• Median survival +14.9 months (36.3 vs 21.4 months)
• Hazard ratio 0.35 indicating 65% reduction in risk of death
• Survival benefit reached statistical significance (log-rank p=0.0218; Cox p=0.0037)
• Prior findings included statistically significant slowing of disease progression with favorable safety

Negative

• Small randomized cohort of 68 patients limits broad generalizability
• Placebo-to-active crossover/open-label design may confound long-term between-arm comparisons
• Data from Phase 2b only; pivotal late-stage trials and regulatory review remain required

Market Reaction

-11.80% $0.88 3.2x vol

15m delay 11 alerts

-11.80% Since News

$0.88 Last Price

$0.87 $1.05 Day Range

-$4M Valuation Impact

$29M Market Cap

3.2x Rel. Volume

Following this news, NRSN has declined 11.80%, reflecting a significant negative market reaction. Our momentum scanner has triggered 11 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $0.88. This price movement has removed approximately $4M from the company's valuation. Trading volume is very high at 3.2x the average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Median survival (PrimeC): 36.3 months Median survival (placebo/crossover): 21.4 months Median survival benefit: Over 14 months +5 more

8 metrics

Median survival (PrimeC) 36.3 months Continuous PrimeC treatment in PARADIGM Phase 2b ALS trial

Median survival (placebo/crossover) 21.4 months Initially placebo, then crossover to PrimeC in PARADIGM trial

Median survival benefit Over 14 months Difference in median survival between PrimeC and placebo/crossover arms

Risk reduction of death 65% Cox model hazard reduction for PrimeC vs placebo (ALS PARADIGM Phase 2b)

Hazard ratio 0.35 (95% CI: 0.17–0.71) PrimeC vs placebo in ALS survival analysis

Log-rank p-value p = 0.0218 Kaplan–Meier survival curve comparison in PARADIGM Phase 2b

Cox model p-value p = 0.0037 Adjusted Cox proportional hazards model for survival benefit

Sample size 68 patients PARADIGM Phase 2b randomized, double-blind, placebo-controlled ALS trial

Market Reality Check

Price: $1.00 Vol: Volume 170,852 is below 2...

normal vol

$1.00 Last Close

Volume Volume 170,852 is below 20-day average of 231,823, suggesting muted participation ahead of this update. normal

Technical Shares at $1 are trading below the $1.3 200-day moving average, reflecting a longer-term downtrend into the news.

Peers on Argus

While NRSN was down 3.85%, peers in momentum scanners were mixed: ITRM and ALLR ...

2 Up 2 Down

While NRSN was down 3.85%, peers in momentum scanners were mixed: ITRM and ALLR were up sharply, while RNTX and CVKD were down, indicating stock-specific factors rather than a uniform sector move.

Common Catalyst Select biotech peers had clinical trial headlines, but overall price action appeared mixed across the group.

Historical Context

5 past events · Latest: Feb 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 09	IP / patent grant	Positive	+8.5%	Australian patent grant extending PrimeC composition protection through October 2042.
Jan 21	IP / Alzheimer’s patent	Positive	-5.2%	U.S. patent for PrimeC in Alzheimer’s with protection through 2043 and PoC study update.
Jan 08	SAB appointment	Positive	+12.4%	Alzheimer’s expert joining SAB alongside positive safety data in RoAD study.
Dec 22	Alzheimer’s trial safety	Positive	+3.8%	Phase 2 Alzheimer’s study showing favorable tolerability with no serious adverse events.
Dec 04	Regulatory planning	Positive	-3.5%	Resumed Canadian regulatory activity and planning for pre‑NDS meeting in April 2026.

Pattern Detected

Positive news has produced mixed reactions: three prior upbeat updates saw gains, while two similarly positive items coincided with next-day declines.

Recent Company History

Over the past few months, NeuroSense has focused on strengthening PrimeC’s clinical and intellectual property position. Patent grants in Australia and the U.S. extended protection into 2042 and 2043, while regulatory work in Canada advanced toward a potential NDS submission by mid‑2026. Alzheimer’s Phase 2 work has emphasized favorable safety, tolerability, and biomarker signals. Against this backdrop, today’s long-term ALS survival data add to the existing Phase 2b PARADIGM dataset, reinforcing PrimeC’s late-stage development narrative built across these prior milestones.

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

An active Form F-3 shelf filed on 2026-01-29 allows NeuroSense to offer up to $150,000,000 of securities, including support for an at-the-market program of up to $6,525,000. The filing carries forward $85,778,066 of unsold securities from a prior F-3 and notes substantial doubt about the company’s ability to continue as a going concern, underscoring reliance on future financings under this shelf.

Market Pulse Summary

The stock is dropping -11.8% following this news. A negative reaction despite statistically signific...

Analysis

The stock is dropping -11.8% following this news. A negative reaction despite statistically significant survival gains—median survival of 36.3 vs 21.4 months and a 65% risk reduction—would fit a pattern where positive news sometimes coincided with declines. Investors have previously sold on good regulatory or IP developments. The existing $150,000,000 shelf filed on 2026-01-29 and disclosed going‑concern risks may have kept attention on potential future financing rather than solely on the strength of the ALS data.

Key Terms

median survival, hazard ratio, open-label, double-blind, +1 more

5 terms

median survival medical

"achieved an estimated median survival of 36.3 months, compared to 21.4 months..."

Median survival is the amount of time from a defined starting point (like diagnosis or treatment) at which half of a group of patients are still alive and half have died. Investors use it to judge how much a medical treatment or clinical result changes patient outcomes — like measuring the midpoint in a race rather than the average finish time — which affects regulatory approval chances, market size, pricing power, and revenue forecasts.

hazard ratio medical

"reduction in the risk of death compared to placebo (hazard ratio: 0.35; 95% CI: 0.17–0.71..."

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.

open-label medical

"during both the double-blind and open-label phases achieved an estimated median survival..."

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

double-blind medical

"both the double-blind and open-label phases achieved an estimated median survival..."

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

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

"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.

AI-generated analysis. Not financial advice.

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.

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/neurosense-announces-statistically-significant-65-reduction-in-risk-of-death-and-greater-than-14-month-median-survival-benefit-with-primec-in-als-302691462.html

SOURCE NeuroSense

FAQ

What survival improvement did NeuroSense (NRSN) report for PrimeC in the PARADIGM Phase 2b trial?

PrimeC was associated with a >14-month median survival improvement, from 21.4 to 36.3 months. According to the company, Kaplan–Meier estimates show this represents roughly a 70% increase in median survival with sustained separation over follow-up.

How much did PrimeC reduce the risk of death in the PARADIGM Phase 2b study (NRSN)?

PrimeC treatment showed a 65% reduction in risk of death versus placebo (HR 0.35). According to the company, the Cox model adjusted for baseline factors gave HR 0.35 with 95% CI 0.17–0.71 and p=0.0037.

Are the PrimeC survival results in PARADIGM statistically significant for NeuroSense (NRSN)?

Yes, the survival benefit reached statistical significance by multiple tests. According to the company, the log-rank test yielded p=0.0218 and the adjusted Cox model p=0.0037, supporting a robust survival signal in this dataset.

How large was the PARADIGM Phase 2b trial that generated PrimeC survival data for NeuroSense (NRSN)?

The randomized trial enrolled 68 people with ALS using a 2:1 active-to-placebo ratio. According to the company, the six-month double-blind period was followed by an open-label extension used for extended survival follow-up.

What are the next steps for PrimeC after NeuroSense's (NRSN) Phase 2b survival findings?

NeuroSense plans to advance PrimeC toward pivotal late-stage development and engage regulators. According to the company, these survival data add long-term clinical context as it pursues late-stage trial design and regulatory discussions.