Last Wednesday, NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) said it scaled up its production of PrimeC to a commercial scale.
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease.
NeuroSense said it bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements.
Additionally, the company partnered with a global contract development and manufacturing organization (CDMO) that currently manufactures PrimeC clinical batches and will support its future commercial supply.
Also Read: EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission
Stability data support a shelf life of at least 36 months at room temperature, and formulation IP granted in 2023 provides protection through 2042.
NeuroSense is working to advance discussions with Health Canada to pursue early market entry through the Notice of Compliance with Conditions (NOC/c) pathway.
Commercial forecasts suggest a potential peak annual revenue of $100–150 million in Canada.
D. Boral Capital initiated coverage on NeuroSense on Monday with a Buy rating and a price forecast of $14.
Analyst Jason Kolbert says, “The mechanistic rationale is supported by both preclinical and translational research, positioning PrimeC as a multimodal therapy in a field still dominated by marginally effective monotherapies.”
D. Boral writes that the ongoing Phase 2b PARADIGM trial is designed to provide further validation and is expected to report topline results in the second half of 2025.
In April, NeuroSense shared new findings from its Phase 2b PARADIGM clinical trial. The data highlights the impact of PrimeC on microRNA (miRNA) modulation, representing a significant development in understanding how the therapy may slow disease progression.
It reveals the consistent effect of PrimeC on altering the expression of miRNAs associated with ALS, aligning with the previously reported clinical benefits, including a 33% reduction in disease progression and a 58% improvement in survival rates observed with PrimeC treatment.
The analyst notes that NeuroSense is expanding its platform into Alzheimer’s and Parkinson’s disease, leveraging the same pathophysiologic targets with modified drug combinations. This modular approach could significantly broaden the company’s addressable market while maintaining development efficiency.
“We believe NeuroSense is at an inflection point where clinical proof-of-concept data, coupled with upcoming catalysts, could drive substantial value creation,” Kolbert adds.
In August 2024, NeuroSense Therapeutics said it was in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize PrimeC for ALS.
Price Action: NRSN stock is up 6.34% at $1.11 at the last check on Monday.
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Latest Ratings for NRSN
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Date |
Firm |
Action |
From |
To |
|---|---|---|---|---|
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Jan 2022 |
Maxim Group |
Initiates Coverage On |
Buy |
View More Analyst Ratings for NRSN
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