FDA Events for NeuroSense Therapeutics (NRSN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroSense Therapeutics (NRSN).
Over the past two years, NeuroSense Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PrimeC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PrimeC - FDA Regulatory Timeline and Events
PrimeC is a drug developed by NeuroSense Therapeutics for the following indication: Amyotrophic lateral sclerosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PrimeC
- Announced Date:
- May 7, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.
AI Summary
NeuroSense Therapeutics Ltd. has reached a major milestone by successfully scaling up its production of PrimeC to a commercial level. This scale-up comes on the heels of promising results from the Phase 2b PARADIGM study, highlighting PrimeC’s potential as a disease-modifying therapy for ALS patients. The achievement builds on robust improvements in their manufacturing process, ensuring that all analytical methods for product release and stability have been fully validated. By partnering with a global Contract Development and Manufacturing Organization (CDMO), NeuroSense secured a dependable supply chain for future production needs. The validated manufacturing process also supports a shelf life of at least 36 months at room temperature. This progress marks a significant step toward bringing PrimeC to market, aiming to address a critical unmet need for new therapeutic options for those suffering from ALS.
Read Announcement - Drug:
- PrimeC
- Announced Date:
- April 24, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics issued a shareholder letter from Chief Executive Officer Alon Ben-Noon.
AI Summary
NeuroSense Therapeutics’ CEO, Alon Ben-Noon, issued a shareholder letter outlining key developments for the company. In his message, he highlighted the upcoming launch of the global Phase 3 clinical trial for PrimeC in ALS, planned for the second half of 2025. Ben-Noon emphasized that advancing this pivotal study is a major step forward in providing robust clinical data for the therapy and its potential impact on patients.
The letter also provided an update on progress with the Canadian regulatory pathway, where discussions with Health Canada are exploring accelerated access through a Notice of Compliance with Conditions (NOC/c). Additionally, Ben-Noon expressed optimism about ongoing strategic partnership discussions with a global pharmaceutical company, noting that although finalizing this multi-regional deal has taken more time than expected, it could transform the company operationally and financially. He thanked shareholders for their continued support as NeuroSense moves forward in its mission.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 9, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics, Ltd. announced promising new findings from its Phase 2b PARADIGM clinical trial.
AI Summary
NeuroSense Therapeutics, Ltd. announced promising findings from its Phase 2b PARADIGM clinical trial for its ALS treatment, PrimeC. The study showed that PrimeC consistently downregulated 161 mature microRNAs (miRNAs) in treated patients, including key miRNAs like miR-199 and miR-181 that are linked to disease progression and neuroinflammation in ALS. These results suggest that PrimeC could help slow the progression of ALS by targeting molecular pathways that drive inflammation and motor neuron degeneration. The modulation of these miRNAs reinforces the potential of PrimeC as a transformative, multi-targeted therapy for ALS. The data builds on earlier clinical observations, supporting PrimeC’s ability to improve survival rates and reduce disease progression, and provides a strong foundation for further studies to explore its impact on miRNA maturation and additional neurodegenerative diseases.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 7, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. provides a business update.
AI Summary
NeuroSense Therapeutics Ltd. provided a business update highlighting major progress with its lead candidate, PrimeC, for treating amyotrophic lateral sclerosis (ALS). The company announced that its Phase 2b study met both primary and secondary endpoints, showing a 33% slower disease progression over 18 months and a 58% improvement in survival rates, while also preserving key functions like speaking and swallowing. PrimeC demonstrated a favorable safety and tolerability profile, which supports its potential to modify the course of ALS. Following a Type C meeting with the FDA, NeuroSense received positive feedback on the Phase 3 study design, now slated to begin in 2025. The company is in ongoing partnership discussions to advance PrimeC towards regulatory approval and eventual commercialization, including plans to file for early commercialization in Canada.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 4, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics, Ltd. announced that two members of its Scientific Advisory Board will present new data from the Company's Phase 2b trial during the General Neurology and Late Breaker sessions at the 77th Annual American Academy of Neurology (AAN) Meeting.
AI Summary
NeuroSense Therapeutics, Ltd. announced that two members of its Scientific Advisory Board will present new data from the company’s Phase 2b trial at the 77th Annual American Academy of Neurology (AAN) Meeting. The presentations will take place during the General Neurology and Late Breaker sessions in San Diego, CA, on April 8, 2025.
Dr. Jeremy Shefner will share clinical data demonstrating PrimeC’s safety, tolerability, and efficacy as an oral candidate for ALS, highlighting its potential to reduce ALS progression while engaging multiple biomarker endpoints. Meanwhile, Dr. Jeffrey Rosenfeld will present insights on microRNA modulation and iron-related markers in ALS treatment, shedding light on the mechanism behind PrimeC’s effects. These presentations underscore the company’s focus on advancing a disease-modifying therapy for ALS.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- March 20, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announced significant progress toward the early commercialization of PrimeC in Canada.
AI Summary
NeuroSense Therapeutics Ltd. announced significant progress toward the early commercialization of its lead ALS therapy, PrimeC, in Canada. Health Canada has invited the company to a pre-New Drug Submission meeting to discuss a potential regulatory pathway for PrimeC. The company is targeting approval by the first half of 2026, which could pave the way for earlier market entry. PrimeC is an innovative, extended-release oral formulation that combines ciprofloxacin and celecoxib. It has shown strong clinical efficacy in trials, including reductions in disease progression and improvements in survival rates. NeuroSense estimates that PrimeC could generate peak annual revenues of $100 to $150 million in the Canadian market alone. This Canadian regulatory development is a critical step in the company’s overall strategy to bring a breakthrough treatment for Amyotrophic Lateral Sclerosis to patients in need.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- December 4, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics announce today statistically significant positive results from the 18-month data analysis of the PARADIGM study, evaluating the efficacy of PrimeC in the treatment of Amyotrophic Lateral Sclerosis (ALS).
AI Summary
NeuroSense Therapeutics announced statistically significant positive results from the 18‐month analysis of its PARADIGM study evaluating PrimeC in ALS treatment. Patients who received PrimeC from the beginning experienced a 33% slower progression of the disease, as shown by nearly an 8-point improvement on the ALS Functional Rating Scale-Revised compared to those who started on placebo before switching to PrimeC. Additionally, continuous treatment with PrimeC led to a striking 58% improvement in survival rates. These results, with a p-value of 0.007, underscore the potential of PrimeC to redefine the standard of care for ALS by offering a more effective approach to slowing disease progression and extending patient survival.
Read Announcement - Drug:
- PrimeC
- Announced Date:
- July 1, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).
AI Summary
NeuroSense Therapeutics Ltd. reported promising results from the 12-month analysis of its PARADIGM Phase 2b study evaluating PrimeC in people with ALS. The data showed that disease progression was slowed by 36% in participants who received PrimeC from the start, compared to those initially given a placebo. The intent-to-treat analysis revealed a statistically significant difference of 6.5 points on the ALS Functional Rating Scale-Revised, with a p-value of 0.009. In addition, participants treated with PrimeC showed a 43% improvement in survival rates. A pre-defined analysis of the per-protocol population further demonstrated a difference of approximately 7.7 points, translating into more than 40% improvement. These significant findings highlight PrimeC’s potential to slow ALS progression and provide a strong rationale for advancing into a Phase 3 clinical trial in the US and Europe.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- May 7, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd announces new analyses from its Phase 2b PARADIGM clinical trial, demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment. .
AI Summary
NeuroSense Therapeutics Ltd has released new data from its Phase 2b PARADIGM clinical trial showing promising results for its ALS drug candidate, PrimeC. In the pre-specified per protocol analysis, the trial demonstrated that PrimeC significantly slowed disease progression by 43% (p=0.02) compared to placebo over six months in high-risk ALS patients. This outcome suggests that PrimeC may offer a meaningful benefit for patients facing rapid disease advancement, potentially delaying the decline associated with ALS. The trial’s findings underscore the potential of targeted therapies to manage severe and progressive diseases. While the study focused on a specific high-risk group within the ALS population, the statistical significance of these results provides a strong basis for further clinical exploration of PrimeC as a treatment option that might improve quality of life and slow the progression of ALS in future larger-scale trials.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 12, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announces lead author Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital, and Julieanne Dorn Professor of Neurology at Harvard Medical School, will be presenting data from the PARADIGM Phase 2 study of PrimeC during an Emerging Science session (equivalent to Late Breaker) at the American Academy of Neurology Annual Meeting.
AI Summary
NeuroSense Therapeutics Ltd. announced that Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital and Julieanne Dorn Professor of Neurology at Harvard Medical School, will present the latest data from the Phase 2 PARADIGM study. This study evaluated PrimeC, an oral candidate for amyotrophic lateral sclerosis (ALS), which met both its primary and secondary endpoints. The presentation, titled "PrimeC, An Oral Candidate for Amyotrophic Lateral Sclerosis, Meets Primary and Secondary Endpoints in the Phase 2b PARADIGM Trial," is scheduled for April 16, 2024 at 5:30 PM local time during an Emerging Science session—comparable to a Late-Breaker session—at the American Academy of Neurology Annual Meeting in Denver, Colorado.
This Emerging Science session highlights breakthrough ALS treatment research for the neurology field and underscores NeuroSense’s commitment to developing innovative therapies for severe neurodegenerative diseases.
Read Announcement
NeuroSense Therapeutics FDA Events - Frequently Asked Questions
As of now, NeuroSense Therapeutics (NRSN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, NeuroSense Therapeutics (NRSN) has reported FDA regulatory activity for PrimeC.
The most recent FDA-related event for NeuroSense Therapeutics occurred on May 7, 2025, involving PrimeC. The update was categorized as "Provided Update," with the company reporting: "NeuroSense Therapeutics Ltd. announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study."
Currently, NeuroSense Therapeutics has one therapy (PrimeC) targeting the following condition: Amyotrophic lateral sclerosis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:NRSN) was last updated on 7/12/2025 by MarketBeat.com Staff
