In This Article:
NeuroSense's Groundbreaking ALS Combination Therapy PrimeC Advances Towards commercialization in Canada; Potential for revenue in Canada alone of $100-150 million dollars. PrimeC Has Previously Demonstrated Unprecedentedly Strong Clinical Efficacy; Wall Street Maintains Buy Rating with AGP giving the company a $7.50 Price Target Representing a Significant Premium Over Current Prices;
NEW YORK, March 20, 2025--(BUSINESS WIRE)--Market News Alerts Reports: NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)* has announced significant progress toward the early commercialization of PrimeC in Canada. According to a Form 6-K filed with the SEC this morning, Health Canada has invited the company to a pre-New Drug Submission (pre-NDS) meeting to discuss a potential Notice of Compliance/conditional (NOC/c) regulatory pathway for PrimeC as a treatment for Amyotrophic Lateral Sclerosis (ALS).
NeuroSense is targeting potential approval in Canada by H1 2026. The company estimates peak annual revenue potential of $100-150M USD in the Canadian market. This meeting marks a critical step in NeuroSense's regulatory strategy for PrimeC
PrimeC is NeuroSense's lead drug candidate for ALS, a novel extended-release oral formulation combining ciprofloxacin and celecoxib. The drug has demonstrated promising results in clinical trials, including the Phase 2b PARADIGM study, which showed a 36% reduction in disease progression and 43% improvement in survival rates compared to placebo.
In December 2024, NeuroSense reported positive FDA feedback on its Phase 3 trial design for PrimeC, with plans to initiate the pivotal study in mid-2025. The company has also announced entering a binding term sheet with a global pharmaceutical company to advance PrimeC's development, which includes substantial upfront payments and funding for the Phase 3 program. This Canadian regulatory development represents a potential pathway to earlier commercialization while the larger Phase 3 program proceeds for global markets.
The neurodegenerative disease treatment market has witnessed transformative licensing deals that highlight the immense value of innovative therapies. GlaxoSmithKline's 2021 collaboration with Alector set a remarkable precedent with a $700 million upfront payment and potential milestone payments of $1.5 billion, while the Biogen and Denali Therapeutics partnership in 2020 involved $560 million upfront and potential milestones approaching $1.125 billion. These deals underscore the pharmaceutical industry's willingness to invest heavily in breakthrough neurological innovations.