NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
0mins
Should l Buy NRSN?
Source: PRnewswire
FDA Approval for Clinical Trial: NeuroSense Therapeutics has received FDA authorization to initiate a pivotal Phase 3 clinical trial for its lead drug candidate, PrimeC, aimed at treating amyotrophic lateral sclerosis (ALS).
Trial Design and Goals: The PARAGON trial will involve 300 ALS patients and is designed to evaluate the efficacy and safety of PrimeC over a 12-month period, with an adaptive design allowing for interim analyses.
Significance of PrimeC: PrimeC is a novel oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms involved in ALS and Alzheimer's Disease.
Commitment to ALS Treatment: NeuroSense emphasizes its dedication to addressing the significant unmet medical needs of ALS patients and plans to share further details about the trial in an upcoming investor webinar.
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Analyst Views on NRSN
Wall Street analysts forecast NRSN stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.000
Low
7.50
Averages
8.25
High
9.00
Current: 1.000
Low
7.50
Averages
8.25
High
9.00
About NRSN
NeuroSense Therapeutics Ltd is an Israel-based clinical-stage pharmaceutical company. The Company is active in field of drug development and treatment offers Amyotrophic Lateral Sclerosis (ALS) patients, as well as other neurodegenerative diseases. The Company's lead product candidate, PrimeC, is an oral formulation of a fixed dose combination composed of a specific ratio of drugs. In addition to PrimeC, the Company has initiated research and development efforts in Alzheimer's disease and Parkinson's disease
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
NeuroSense Secures Australian Patent, Strengthening Global IP for PrimeC
- Global IP Expansion: NeuroSense has secured Australian Patent No. 2022370513, further enhancing global intellectual property protection for PrimeC, with patent coverage extending through 2042, demonstrating the company's strategic positioning in key markets.
- Support from US Patent: The grant of this patent follows the approval of US Patent 12,097,185, indicating that NeuroSense's intellectual property protection strategy is progressing steadily in critical markets, thereby strengthening its competitive edge.
- PrimeC Drug Development: PrimeC is a fixed-dose oral therapy combining ciprofloxacin and celecoxib, designed to combat ALS and Alzheimer's disease through a multi-target mechanism, showcasing its potential in clinical stages.
- Addressing Market Demand: With the number of ALS patients expected to grow by 24% by 2040, NeuroSense's IP protection and the development of PrimeC will help meet the increasing market demand, driving long-term value creation.
See More
NeuroSense Therapeutics Secures U.S. Patent for PrimeC Alzheimer’s Therapy Valid Through 2043
- Patent Protection Strengthened: NeuroSense Therapeutics has been granted a patent by the U.S. Patent and Trademark Office covering the use of its PrimeC combination therapy for Alzheimer’s disease, valid through 2043, thereby enhancing the company's intellectual property position in this field.
- Clinical Research Progress: The company has completed a proof-of-concept study in Alzheimer’s disease and expects to report clinical and biomarker outcomes in the first quarter of 2026, which will provide crucial data support for the market potential of its product.
- Market Reaction: Following the announcement, NRSN's stock price fell 2.94% in premarket trading to $0.99, reflecting a cautious market sentiment that may impact investor confidence.
- Strategic Implications: The acquisition of this patent not only provides legal protection for NeuroSense's PrimeC program but may also attract more investor interest in its innovative potential in the Alzheimer’s treatment space.
See More
NeuroSense Secures U.S. Patent for PrimeC Combination in Alzheimer's Treatment
- Patent Grant: NeuroSense has been granted U.S. Patent No. 12,527,768, which protects the use of the PrimeC combination in Alzheimer's disease, thereby strengthening its intellectual property portfolio and supporting long-term development and commercialization until 2043.
- Clinical Study Progress: The company recently concluded its proof-of-concept study for Alzheimer's disease, with top-line results indicating a favorable safety and tolerability profile, and clinical and biomarker outcomes are expected in Q1 2026, potentially facilitating further clinical trials.
- Market Demand: Alzheimer's disease affects over 30 million people globally, and existing therapies provide only limited symptomatic relief; the multi-mechanism targeting strategy of PrimeC is poised to address significant unmet treatment needs, enhancing market potential.
- Combination Drug Advantage: PrimeC is a unique fixed-dose combination of two FDA-approved drugs designed to synergistically inhibit the progression of neurodegenerative diseases, showcasing potential breakthrough advancements in the treatment of ALS and AD.
See More
NeuroSense Appoints Alzheimer's Expert Prof. Arnold to Advance PrimeC Development
- Expert Appointment: NeuroSense announced the addition of Prof. Steven E. Arnold from Harvard Medical School to its Scientific Advisory Board, leveraging his extensive experience in neurodegenerative disease research to enhance the company's scientific leadership in Alzheimer's and ALS.
- Clinical Research Progress: The company recently completed its proof-of-concept Alzheimer's study, with initial results indicating a favorable safety and tolerability profile, and clinical and biomarker outcomes are expected in Q1 2026, potentially providing crucial data for treatment strategies.
- Multi-Target Mechanism: PrimeC, NeuroSense's lead drug candidate, combines two FDA-approved drugs to target multiple biological pathways relevant to Alzheimer's disease, which may offer more effective treatment options and address the significant unmet need for disease-modifying therapies in the market.
- Market Potential: Alzheimer's disease affects over 30 million people globally, with existing therapies providing only limited symptomatic relief; NeuroSense's development strategy aims to fill this substantial medical gap, enhancing the company's competitiveness in the rapidly growing neurodegenerative disease market.
See More
Galectin Secures $10M Credit Line, FDA Provides Guidance on Regulatory Pathway
- Credit Support: Galectin Therapeutics Inc. secured a $10 million credit line, ensuring funding to cover expected expenditures through March 2027, thereby enhancing its R&D capabilities in the NASH cirrhosis treatment space.
- FDA Guidance: The FDA provided written feedback on Galectin's regulatory pathway for belapectin, marking a significant advancement in the company's drug development efforts, which could expedite its product's market entry.
- Market Reaction: Galectin's stock rose by 1% to $4.03 in Wednesday's trading, reflecting investor optimism regarding its financing and FDA support.
- Strategic Implications: This credit line and FDA guidance will provide Galectin with essential funding and regulatory backing in the competitive biopharmaceutical market, aiding its future clinical trials and market launch efforts.
See More
NeuroSense Completes Safety Analysis of PrimeC for Alzheimer's with Favorable Data
- Safety Analysis Completed: NeuroSense Therapeutics has completed the safety analysis of PrimeC in the NST-AD-001 study for Alzheimer's disease, indicating a favorable tolerability profile with no serious adverse events, suggesting potential safety in clinical applications.
- Clinical Trial Progress: NST-AD-001 is a Phase 2 randomized, double-blind, placebo-controlled study, with clinical observations and biomarker data expected to be released in Q1 2026, which will further validate the drug's efficacy.
- Innovative Drug Combination: PrimeC is a unique fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib, which has received orphan drug status from both the FDA and EMA, highlighting its innovative potential in treating Alzheimer's disease.
- Market Performance Review: Over the past year, NeuroSense shares have fluctuated between $0.763 and $2.60, closing up 3.83% at $0.84 on Monday, reflecting positive market sentiment towards its clinical advancements.
See More
NeuroSense Secures Australian Patent, Strengthening Global IP for PrimeC
- Global IP Expansion: NeuroSense has secured Australian Patent No. 2022370513, further enhancing global intellectual property protection for PrimeC, with patent coverage extending through 2042, demonstrating the company's strategic positioning in key markets.
- Support from US Patent: The grant of this patent follows the approval of US Patent 12,097,185, indicating that NeuroSense's intellectual property protection strategy is progressing steadily in critical markets, thereby strengthening its competitive edge.
- PrimeC Drug Development: PrimeC is a fixed-dose oral therapy combining ciprofloxacin and celecoxib, designed to combat ALS and Alzheimer's disease through a multi-target mechanism, showcasing its potential in clinical stages.
- Addressing Market Demand: With the number of ALS patients expected to grow by 24% by 2040, NeuroSense's IP protection and the development of PrimeC will help meet the increasing market demand, driving long-term value creation.
See More
NeuroSense Therapeutics Secures U.S. Patent for PrimeC Alzheimer’s Therapy Valid Through 2043
- Patent Protection Strengthened: NeuroSense Therapeutics has been granted a patent by the U.S. Patent and Trademark Office covering the use of its PrimeC combination therapy for Alzheimer’s disease, valid through 2043, thereby enhancing the company's intellectual property position in this field.
- Clinical Research Progress: The company has completed a proof-of-concept study in Alzheimer’s disease and expects to report clinical and biomarker outcomes in the first quarter of 2026, which will provide crucial data support for the market potential of its product.
- Market Reaction: Following the announcement, NRSN's stock price fell 2.94% in premarket trading to $0.99, reflecting a cautious market sentiment that may impact investor confidence.
- Strategic Implications: The acquisition of this patent not only provides legal protection for NeuroSense's PrimeC program but may also attract more investor interest in its innovative potential in the Alzheimer’s treatment space.
See More
NeuroSense Secures U.S. Patent for PrimeC Combination in Alzheimer's Treatment
- Patent Grant: NeuroSense has been granted U.S. Patent No. 12,527,768, which protects the use of the PrimeC combination in Alzheimer's disease, thereby strengthening its intellectual property portfolio and supporting long-term development and commercialization until 2043.
- Clinical Study Progress: The company recently concluded its proof-of-concept study for Alzheimer's disease, with top-line results indicating a favorable safety and tolerability profile, and clinical and biomarker outcomes are expected in Q1 2026, potentially facilitating further clinical trials.
- Market Demand: Alzheimer's disease affects over 30 million people globally, and existing therapies provide only limited symptomatic relief; the multi-mechanism targeting strategy of PrimeC is poised to address significant unmet treatment needs, enhancing market potential.
- Combination Drug Advantage: PrimeC is a unique fixed-dose combination of two FDA-approved drugs designed to synergistically inhibit the progression of neurodegenerative diseases, showcasing potential breakthrough advancements in the treatment of ALS and AD.
See More
NeuroSense Appoints Alzheimer's Expert Prof. Arnold to Advance PrimeC Development
- Expert Appointment: NeuroSense announced the addition of Prof. Steven E. Arnold from Harvard Medical School to its Scientific Advisory Board, leveraging his extensive experience in neurodegenerative disease research to enhance the company's scientific leadership in Alzheimer's and ALS.
- Clinical Research Progress: The company recently completed its proof-of-concept Alzheimer's study, with initial results indicating a favorable safety and tolerability profile, and clinical and biomarker outcomes are expected in Q1 2026, potentially providing crucial data for treatment strategies.
- Multi-Target Mechanism: PrimeC, NeuroSense's lead drug candidate, combines two FDA-approved drugs to target multiple biological pathways relevant to Alzheimer's disease, which may offer more effective treatment options and address the significant unmet need for disease-modifying therapies in the market.
- Market Potential: Alzheimer's disease affects over 30 million people globally, with existing therapies providing only limited symptomatic relief; NeuroSense's development strategy aims to fill this substantial medical gap, enhancing the company's competitiveness in the rapidly growing neurodegenerative disease market.
See More
Galectin Secures $10M Credit Line, FDA Provides Guidance on Regulatory Pathway
- Credit Support: Galectin Therapeutics Inc. secured a $10 million credit line, ensuring funding to cover expected expenditures through March 2027, thereby enhancing its R&D capabilities in the NASH cirrhosis treatment space.
- FDA Guidance: The FDA provided written feedback on Galectin's regulatory pathway for belapectin, marking a significant advancement in the company's drug development efforts, which could expedite its product's market entry.
- Market Reaction: Galectin's stock rose by 1% to $4.03 in Wednesday's trading, reflecting investor optimism regarding its financing and FDA support.
- Strategic Implications: This credit line and FDA guidance will provide Galectin with essential funding and regulatory backing in the competitive biopharmaceutical market, aiding its future clinical trials and market launch efforts.
See More
NeuroSense Completes Safety Analysis of PrimeC for Alzheimer's with Favorable Data
- Safety Analysis Completed: NeuroSense Therapeutics has completed the safety analysis of PrimeC in the NST-AD-001 study for Alzheimer's disease, indicating a favorable tolerability profile with no serious adverse events, suggesting potential safety in clinical applications.
- Clinical Trial Progress: NST-AD-001 is a Phase 2 randomized, double-blind, placebo-controlled study, with clinical observations and biomarker data expected to be released in Q1 2026, which will further validate the drug's efficacy.
- Innovative Drug Combination: PrimeC is a unique fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib, which has received orphan drug status from both the FDA and EMA, highlighting its innovative potential in treating Alzheimer's disease.
- Market Performance Review: Over the past year, NeuroSense shares have fluctuated between $0.763 and $2.60, closing up 3.83% at $0.84 on Monday, reflecting positive market sentiment towards its clinical advancements.
See More
