US Market News
1月前
NeuroSense Announces Pricing of Insider-Led PIPE FinancingApril 28, 2026 2:30 PM
PR Newswire (US)
Financing led by CEO Alon Ben-Noon and CFO Or Eisenberg, alongside participation from an existing significant shareholderCAMBRIDGE, Mass., April 28, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 750,000 ordinary shares at a price of $0.80 per share, representing a purchase price of 6.7% above the closing pricing of NeuroSense's ordinary shares on April 27, 2026.
The private placement is subject to customary closing conditions and is expected to close during the week of May 3, 2026.The private placement included participation from Company insiders and a leading existing shareholder. Chief Executive Officer Alon Ben-Noon, Chief Financial Officer Or Eisenberg, and a significant existing investor each committed $200,000 in the offering.The Company intends to use the proceeds for general corporate purposes ahead of upcoming clinical and regulatory milestones.The offering is being made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the offering may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About NeuroSenseNeuroSense 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 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 the offering, including as to the consummation of the offering described above, the expected gross proceeds from the offering, the intended use of proceeds and the timing of the receipt of proceeds of the offering, 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; 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.Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
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Original: NeuroSense Announces Pricing of Insider-Led PIPE Financing
US Market News
2月前
NeuroSense Granted Brazilian Patent Covering PrimeC CompositionApril 6, 2026 9:20 AM
PR Newswire (US)
Patent Protection Through October 2042Follows prior patent grants in the U.S. and AustraliaFurther strengthens NeuroSense's global intellectual property portfolioCAMBRIDGE, Mass., April 6, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense" or the "Company"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Brazilian Patent and Trademark Office (INPI) has granted Brazilian Patent No. BR 112024007727-6, entitled "Compositions Comprising Ciprofloxacin and Celecoxib." The granted Brazilian patent, following prior approval of the corresponding U.S. patent (12,097,185) and Australian patent (2022370513), provides protection for NeuroSense's proprietary PrimeC composition in Brazil and extends patent coverage through October 2042, further strengthening the Company's global intellectual property estate and supporting the long-term development and potential commercialization of PrimeC in ALS, Alzheimer's disease and additional neurodegenerative indications."This patent grant further reinforces the strength and durability of our intellectual property strategy around PrimeC," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "Securing composition-of-matter protection in Brazil is another important step in expanding our global IP footprint as we advance PrimeC toward pivotal development and potential commercialization."PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib in a synchronized, extended-release formulation specifically targeted to deliver both agents in a coordinated manner - a key differentiator versus simple co-administration. The formulation is designed to enable consistent exposure across multiple disease pathways implicated in ALS, including neuroinflammation, iron dysregulation, and miRNA dysregulation, supporting a multi-target disease-modifying approach.We are preparing for initiation of a Phase 3 pivotal clinical trial for PrimeC in ALS (PARAGON), following positive Phase 2b PARADIGM results and clearance from the FDA.About NeuroSenseNeuroSense 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 PrimeCPrimeC, 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 ALSAmyotrophic 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 Alzheimer's Disease
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.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 PrimeC pivotal 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 we do not complete in a timely fashion the PrimeC pivotal trial, and that the single pivotal trial will not be sufficient to support a New Drug Application submission; uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; 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; the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals; 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
View original content:https://www.prnewswire.com/news-releases/neurosense-granted-brazilian-patent-covering-primec-composition-302734651.htmlSOURCE NeuroSense
Original: NeuroSense Granted Brazilian Patent Covering PrimeC Composition
US Market News
2月前
NeuroSense Therapeutics Announces Receipt of Nasdaq Notifications Regarding Minimum Bid Price and Market Value RequirementsApril 3, 2026 10:02 AM
PR Newswire (US)
Notifications have no immediate effect on the listing or trading of the Company's securities on NasdaqNasdaq has provided the Company until September 29, 2026 to regain compliance with both requirementsThe Company is actively evaluating actions to regain compliance, with a clear focus on initiatives that are aligned with and supportive of long-term shareholder valueCAMBRIDGE, Mass., April 3, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today announced that it received two notification letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") on April 2, 2026, indicating that the Company is not in compliance with certain continued listing requirements of The Nasdaq Capital Market. The first notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share, since the closing bid price of the Company's ordinary shares was below $1.00 per share for 30 consecutive business days, from February 18, 2026 through March 31, 2026.The second notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires listed securities to maintain a minimum market value of listed securities ("MVLS") of $35 million, since the Company's MVLS was below $35 million for 30 consecutive business days over the same period.These notifications have no immediate effect on the listing or trading of the Company's securities on Nasdaq. The Company's ordinary shares and warrants will continue to trade on The Nasdaq Capital Market under the symbols "NRSN" and "NRSNW," respectively.In accordance with Nasdaq Listing Rules, the Company has a compliance period of 180 calendar days, or until September 29, 2026, to regain compliance with both the minimum bid price requirement and the MVLS requirement. To regain compliance, the Company's ordinary shares must maintain a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, and the Company's MVLS must close at $35 million or more for a minimum of 10 consecutive business days, in each case subject to Nasdaq's discretion.The Company continues to actively monitor the closing bid price of its ordinary shares and its MVLS and is evaluating available actions to regain compliance with Nasdaq's continued listing requirements, with a clear focus on initiatives that support and enhance long-term shareholder value. About NeuroSenseNeuroSense 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 StatementsThis 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, reporting of data, meetings and regulatory decisions. 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 uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; 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 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
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Original: NeuroSense Therapeutics Announces Receipt of Nasdaq Notifications Regarding Minimum Bid Price and Market Value Requirements
US Market News
2月前
NeuroSense Therapeutics Reports Year End 2025 Financial Results and Provides Business UpdateMarch 31, 2026 9:20 AM
PR Newswire (US)
2025 marked transition of PrimeC into a late-stage clinical asset with FDA-cleared Phase 3 program in ALSStatistically significant survival benefit demonstrated, including 65% reduction in risk of death and >14-month median survival advantageResults published in JAMA Neurology, providing high-level peer-reviewed validation of clinical and biological activityAdvancing toward key regulatory milestones with planned pre-NDS meeting in Canada and near-term Alzheimer's readoutCAMBRIDGE, Mass., March 31, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense" or the "Company"), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today reported its financial results for the year ended December 31, 2025 and provided a business update.
"2025 was a transformational year for NeuroSense, as we advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clear regulatory path forward," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "As we entered 2026, we further strengthened our clinical and scientific foundation with statistically significant survival data and publication of our results in JAMA Neurology. Together, these milestones position PrimeC as a differentiated therapeutic candidate with the potential to meaningfully impact people with ALS and potentially other neurodegenerative diseases."Business Highlights from 20252025 marked a transformative year for NeuroSense, as the Company advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clearly defined regulatory and development pathway. Results from the Phase 2b PARADIGM study demonstrated approximately 33% slowing in disease progression over 18 months, alongside a substantial reduction in ALS-related complications. During the year, NeuroSense further strengthened its data package through additional biomarker analyses, including microRNA data, supporting the biological activity of PrimeC, supporting PrimeC's potential as a disease-modifying therapy.The Company also completed commercial-scale manufacturing and advanced its regulatory strategy, including engagement with Health Canada and ongoing partnership discussions.Importantly, in November 2025, NeuroSense received FDA clearance to initiate the PARAGON Phase 3 trial in ALS, marking a key inflection point in the Company's development trajectory.NeuroSense also reported early signals of biological activity and statistically significant reductions in key biomarkers associated with Alzheimer's disease, supporting broader potential across neurodegenerative diseases.Recent Developments and First Quarter 2026 HighlightsSince the beginning of 2026, NeuroSense has continued to strengthen PrimeC's position through significant clinical and scientific milestones. The Company reported statistically significant survival data from its Phase 2b study, demonstrating a 65% reduction in the risk of death and a greater than 14-month median survival benefit.Further reinforcing the strength of its clinical package, results from the PARADIGM trial were published in JAMA Neurology, highlighting meaningful clinical outcomes and biological activity, including biomarker changes consistent with the proposed mechanism of action.NeuroSense also expanded its scientific visibility through presentations at leading international conferences and strengthened its intellectual property portfolio with newly granted patents in the United States and internationally. In addition, the Company enhanced its Scientific Advisory Board with leading experts to support continued development in ALS and Alzheimer's disease.Upcoming Expected MilestonesAdditional biomarkers readouts from PARADIGMReadouts from the Phase 2 Alzheimer's studyPlanned pre-NDS meeting with Health Canada in May 2026Potential NDS submission in Canada, subject to regulatory feedbackContinued preparation for initiation of the Phase 3 PARAGON trial in ALSFinancial ResultsResearch and development expenses for the years ended December 31, 2025 and 2024 were $6.2 million and $5.7 million, respectively. The increase of $0.5 million, or 8.8%, was mainly attributed to an increase in share-based payment expenses and increase in our salaries and social benefits expenses which were partly offset by a decrease of our expenses to subcontractors and consultants.General and administrative expenses for the years ended December 31, 2025 and 2024 were $4.9 million and $4.2 million, respectively. The increase of $0.7 million, or 16.6%, was mainly attributed to an increase in share-based compensation.As of December 31, 2025, NeuroSense had cash of approximately $0.2 million.A summary of NeuroSense's consolidated financial results is included in the tables below.A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://neurosense.investorroom.com/sec-filings. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at ir@neurosense-tx.com. NeuroSense Therapeutics Ltd.Consolidated Statements of Financial Position(U.S. dollars in thousands, except share and per share data)
As of December 31,
2025
2024Assets
Current assets:
Cash and cash equivalents$166
$ 3,378 Other receivables
565
989 Restricted deposits
47
35Total current assets
778
4,402
Non-current assets:
Property and equipment, net
58
66 Right of use assets
170
84 Restricted deposit
22
23Total non-current assets
250
173Total assets$1,028
$ 4,575
Liabilities and shareholders' equity
Current liabilities:
Trade payables$799
$ 1,160 Other current liabilities
1,717
832Total current liabilities
2,516
1,992
Non-current liabilities:
Lease liability less current maturity
72
-
72
-
Total liabilities
2,588
1,992
Shareholders' equity (deficit):
Ordinary shares, no par value:
Authorized: 90,000,000 shares at December 31, 2025 and December 31, 2024;
Issued and outstanding: 32,557,174 and 23,228,941 shares at December 31, 2025 and
December 31, 2024, respectively
-
-Share Premium and Capital Reserve
46,225
39,243Accumulated deficit
(47,785)
(36,660)Total shareholders' equity (deficit)
(1,560)
2,583Total liabilities and shareholders' equity$1,028
$ 4,575 NeuroSense Therapeutics Ltd.Consolidated Statements of Income and Comprehensive Loss(U.S. dollars in thousands, except share and per share data)
For the years ended
December 31
2025
2024
2023Research and development expenses $(6,227)
$ (5,698)
$ (7,274)
General and administrative expenses
(4,858)
(4,204)
(4,775)
Operating loss
(11,085)
(9,902)
(12,049)
Financing income (expenses), net
(40)
(308)
1,942
Net loss and comprehensive loss$(11,125)
$ (10,210)
$ (10,107)
Basic and diluted net loss per share$(0.44)
$ (0.54)
$ (0.74)
Weighted average number of ordinary shares used in computing
basic net loss per share
25,481,343
18,602,082
13,640,168 NeuroSense Therapeutics Ltd.Consolidated Statements of Changes in Equity (deficit)(U.S. dollars in thousands, except share and per share data)
Ordinary
SharesShare
Premium and
CapitalAccumulatedTotal
Equity
NumberAmountReserveDeficit(Deficit)Balance as of January 1, 2023
11,781,963
$ -
$ 21,858
$ (16,014)
$ 5,844
Issuance of shares and pre-funded warrants,net
1,333,600
-
806
-
806Exercise of pre-funded warrants, options and vested RSUs
2,263,479
-
-
-
-Share based compensation
-
-
1,698
-
1,698Net loss and comprehensive loss
-
-
-
(10,107)
(10,107)
Balance as of December 31, 2023
15,379,042
$ -
$ 24,362
$ (26,121)
$ (1,759)
Issuance of shares and pre-funded warrants, net
5,981,238
-
10,806
-
10,806Exercise of pre-funded warrants, options and vested RSUs
1,573,000
-
(*)
-
(*)Issuance of shares due to SEPA agreement
224,697
281
-
281Reclassification of warrants into equity
-
-
1,695
(329)
1,366Bonus accrual reclassification to equity
-
-
1,434
-
1,434Share-based compensation
70,964
-
665
-
665Net loss and comprehensive loss
-
-
-
(10,210)
(10,210
Balance as of December 31, 2024
23,228,941
$ -
$ 39,243
$ (36,660)$$ 2,583
Issuance of shares, net
3,546,528
-
4,410
-
4,410Exercise of options, pre funded warrants and vested RSUs
1,583,000
-
22
-
22Conversion of liability into shares
476,435
-
410
-
410Share based compensation
3,722,270
-
2,140
-
2,140Net loss and comprehensive loss
-
-
-
(11,125)
(11,125
Balance as of December 31, 2025
32,557,174
-
46,225
(47,785)
(1,560(*) less than $1. About NeuroSenseNeuroSense 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 PrimeCPrimeC, 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 ALSAmyotrophic 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 StatementsThis 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, reporting of data, 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 the timing of regulatory filings, meetings and regulatory decisions; 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 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
View original content:https://www.prnewswire.com/news-releases/neurosense-therapeutics-reports-year-end-2025-financial-results-and-provides-business-update-302730062.htmlSOURCE NeuroSense
Original: NeuroSense Therapeutics Reports Year End 2025 Financial Results and Provides Business Update
US Market News
3月前
/C O R R E C T I O N -- NeuroSense/March 18, 2026 10:44 AM
PR Newswire (US)
In the news release, PrimeC New Data to Be Presented at AD/PD™ 2026 Conference, issued 18-Mar-2026 by NeuroSense over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows:
PrimeC New Data to Be Presented at AD/PD™ 2026 Conference
Dr. Christian Lunetta to Present "From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial"CAMBRIDGE, Mass., March 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 that Dr. Christian Lunetta will present new data and insights on the development of PrimeC, the company's investigational therapy for amyotrophic lateral sclerosis (ALS), at the AD/PD™ 2026 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders, to be held in Copenhagen, Denmark, on March 19, 2026.
Dr. Lunetta's presentation, titled "From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial," will take place during the symposium "Mechanisms and Therapeutics in the ALS-FTD Spectrum (SOD-1, TDP-43, C9ORF72 and TMEM106B)."The presentation will review key clinical and biomarker findings from the Phase 2b PARADIGM trial, which evaluated PrimeC in people living with ALS. The data provide important insights into disease mechanisms and treatment effects that helped inform the design of the company's global Phase 3 PARAGON trial, currently being advanced to further evaluate PrimeC's safety and efficacy."ALS is one of the most complex neurodegenerative diseases, and advancing therapeutic development requires the integration of rigorous clinical research with deeper biological insight," said Dr. Christian Lunetta. "The clinical findings emerging from the PARADIGM trial, together with the expanding biomarker analyses, provide an important scientific foundation as we advance toward the PARAGON Phase 3 study. I look forward to sharing these results with the scientific community at AD/PD 2026 and to contributing, together with fellow investigators, to the next stage of clinical development as we work to advance meaningful therapeutic options for people living with ALS.""We are deeply appreciative of Dr. Lunetta's role in presenting these findings and of his contribution as part of the clinical investigator community behind this work," said Dr. Shiran Zimri, NeuroSense VP of Research and Development and Canada Country Lead. "The timing of this presentation, coming just days after the publication of the PARADIGM results in JAMA Neurology and at such a highly regarded scientific forum, is especially meaningful. It creates a unique moment where robust, peer-reviewed data can immediately be brought into scientific exchange and critical discussion. For us, this is not only about sharing results, but about engaging the field in a deeper understanding of the clinical and biomarker insights from PARADIGM as we advance with urgency toward our global Phase 3 PARAGON study."The PARAGON Phase 3 trial is planned as a multinational, randomized, double-blind, placebo-controlled study designed to further evaluate PrimeC's potential to slow disease progression in people living with ALS.NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.About NeuroSenseNeuroSense Therapeutics 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 PrimeCPrimeC, 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 ALSAmyotrophic 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 StatementsThis 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.Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
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Original: /C O R R E C T I O N -- NeuroSense/
US Market News
3月前
JAMA Neurology Publishes Results from PARADIGM Phase 2b Trial of PrimeC in ALS Demonstrating Meaningful Clinical Outcomes and Biological ActivityMarch 16, 2026 11:33 AM
PR Newswire (US)
The Journal of the American Medical Association (JAMA Neurology) publication highlights consistent clinical and biomarker findings from NeuroSense PARADIGM Phase 2b trial in ALS, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkersCAMBRIDGE, Mass., March 16, 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 results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology.
Earlier today, Mass General Brigham (MGB) and Barrow Neurological Institute (BNI) issued a joint announcement highlighting the publication and the contributions of the investigators involved in the PARADIGM trial. NeuroSense is honored to collaborate with these leading ALS research centers of excellence and their distinguished clinical teams in advancing research for people living with ALS.PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension.PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways.The publication was authored by a distinguished international group of ALS investigators, including Merit Cudkowicz, MD, MSc (Mass General Brigham and Harvard Medical School), Vivian Drory, MD (Tel-Aviv Sourasky Medical Centre), Adriano Chiò, MD, PhD (University of Torino), Christian Lunetta, MD (IRCCS Maugeri), Christen Shoesmith, MD (London Health Sciences Centre), Ruben van Eijk, MD, PhD (UMC Utrecht), Jeffrey Rosenfeld, MD, PhD (Loma Linda University), and Jeremy Shefner, MD, PhD (Barrow Neurological Institute), together with additional collaborators across North America, Europe, and Israel.Key highlights from the PARADIGM phase 2b study publishedStrong safety and tolerability profile: PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events mild to moderate and transient.Clinically meaningful functional outcomes: Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001).Reduction in risk of major ALS complications: Early initiation of PrimeC was associated with a 64% relative reduction in risk of ALS-related complications (p=0.02), including respiratory failure, hospitalization, or death.Biological evidence supporting disease modification: PrimeC treatment was associated with significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting its biological activity and reinforcing the potential for disease-modifying effects.Supports advancement to Phase 3: These findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS."ALS is one of the most serious neurological diseases, and there is an urgent need for therapies that can meaningfully alter its course," said Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School. "What is particularly noteworthy about the PARADIGM results is the consistency of the findings across clinical outcomes and disease-relevant biomarkers, in addition to good safety. These results provide a strong scientific rationale for continuing the clinical development of PrimeC and support its evaluation in a larger confirmatory Phase 3 trial.""What stands out about the PARADIGM study is the multiple clinical endpoints suggest the same level of clinical benefit and that multiple biomarkers are consistent with clinical endpoints," said Jeremy M. Shefner, MD, PhD, Professor of Neurology at the Barrow Neurological Institute and corresponding author of the publication. "Together, these findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 trial designed to validate its impact for patients.""The publication of the PARADIGM results in the prestigious JAMA Neurology represents an important milestone for NeuroSense and for people living with ALS," said Ferenc Tracik, MD, Chief Medical Officer of NeuroSense Therapeutics. "This article integrates PrimeC's safety, clinical, and biomarker data over 18 months. The consistent findings of slower functional decline, reduced risk of ALS-related complications, and modulation of iron-regulatory and microRNA biomarkers strengthen confidence in PrimeC's potential as a disease-modifying therapy. These findings directly informed the design of our Phase 3 trial, which has received FDA clearance to proceed." PARADIGM Study OverviewPARADIGM was a multinational Phase 2b randomized, double-blind, placebo-controlled clinical trial conducted at leading ALS referral centers in Italy, Canada, and Israel.The study enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo for six months. The double-blind phase was followed by a 12-month open-label extension, during which all participants received PrimeC while maintaining blinding to original treatment assignment.Even though the trial was not powered to demonstrate definitive efficacy, participants who received PrimeC from the outset maintained a clinically meaningful 7.92-point functional advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007), with the largest improvement observed in the bulbar domain (p=0.001), a key determinant of speech, swallowing, and quality of life in ALS.In addition, ALS complication-free survival demonstrated a 64% relative risk reduction favoring early treatment (p=0.02), suggesting potential long-term clinical benefit.Biomarker FindingsThe trial also demonstrated biological activity consistent with PrimeC's proposed multi-pathway mechanism.Markers of iron metabolism, which are frequently dysregulated in ALS, showed favorable significant changes, including preservation of transferrin levels and stabilization of ferritin.In parallel, plasma microRNA analysis revealed statistically significant downregulation of ALS-associated microRNAs miR-199a-3p, miR-199a-5p, miR-181a-5p, and miR-181b-5p, which have been linked to disease severity and prognosis.Together, these findings provide biological evidence that PrimeC engages disease-relevant pathways and support its continued development as a potential disease-modifying therapy.About PrimeCPrimeC is an investigational fixed-dose oral combination therapy composed of celecoxib and ciprofloxacin in a synchronized extended-release formulation. The therapy is designed to simultaneously target multiple biological mechanisms implicated in ALS progression, including neuroinflammation, iron dysregulation, and microRNA dysregulation.The therapeutic rationale for PrimeC is supported by preclinical evidence across ALS disease models and human induced pluripotent stem cell–derived motor neuron systems and has now been evaluated in a randomized Phase 2b clinical trial.About NeuroSense TherapeuticsNeuroSense Therapeutics is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for people living with ALS and other neurodegenerative diseases. The company's lead program, PrimeC, is designed to simultaneously target multiple biological pathways implicated in ALS progression.Forward-Looking StatementsThis 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.Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/jama-neurology-publishes-results-from-paradigm-phase-2b-trial-of-primec-in-als-demonstrating-meaningful-clinical-outcomes-and-biological-activity-302714793.htmlSOURCE NeuroSense
Original: JAMA Neurology Publishes Results from PARADIGM Phase 2b Trial of PrimeC in ALS Demonstrating Meaningful Clinical Outcomes and Biological Activity
US Market News
3月前
PrimeC Long-Term Survival Data to Be Presented at a Leading ALS Scientific ConferenceMarch 9, 2026 11:07 AM
PR Newswire (US)
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 NeuroSenseNeuroSense 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 PrimeCPrimeC, 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 ALSAmyotrophic 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 StatementsThis 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.Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/primec-long-term-survival-data-to-be-presented-at-a-leading-als-scientific-conference-302708280.htmlSOURCE NeuroSense
Original: PrimeC Long-Term Survival Data to Be Presented at a Leading ALS Scientific Conference
US Market News
4月前
NeuroSense Expands Global IP Protection Strategy With Granted Australian Patent Covering PrimeC CompositionFebruary 9, 2026 9:20 AM
PR Newswire (US)
Strengthens Global IP Portfolio for PrimeC Through 2042CAMBRIDGE, Mass., Feb. 9, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Australian Patent Office (IP Australia) has granted Australian Patent No. 2022370513, entitled "Compositions Comprising Ciprofloxacin and Celecoxib," representing another strategic step in the continued expansion of the Company's global intellectual property protection for PrimeC.
The granted Australian patent, following prior approval of the corresponding U.S. patent (12,097,185), further expands NeuroSense's patent protection across key global markets and reinforces the Company's exclusivity strategy for PrimeC, with patent coverage extending through October 2042. NeuroSense continues to strengthen the company's global intellectual property estate and to support the long-term development and potential commercialization of PrimeC in ALS, Alzheimer's disease and other neurodegenerative indications. "Securing patent protection in Australia, in addition to the already granted patent in the US, is an important step in executing our global IP protection strategy for PrimeC," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "As we advance PrimeC toward pivotal development and potential commercialization, building a broad, durable IP estate across major jurisdictions is central to supporting long-term value creation."PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib in a synchronized, extended-release formulation specifically engineered to deliver both agents in a coordinated manner - a key differentiator versus simple co-administration. The formulation enables consistent exposure across multiple disease pathways implicated in ALS, including neuroinflammation, iron dysregulation, and miRNA dysregulation, supporting a multi-target disease-modifying approach.PrimeC is Phase 3-ready in ALS, following positive Phase 2b PARADIGM results and FDA clearance of the pivotal Phase 3 protocol.About NeuroSenseNeuroSense 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 PrimeCPrimeC, 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 ALSAmyotrophic 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 Alzheimer's Disease
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.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 the length of patent coverage, 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; 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.Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/neurosense-expands-global-ip-protection-strategy-with-granted-australian-patent-covering-primec-composition-302682567.htmlSOURCE NeuroSense
Original: NeuroSense Expands Global IP Protection Strategy With Granted Australian Patent Covering PrimeC Composition