21ьз╕ C

Market Alert: NeuroSense Therapeutics Advances Toward Early Canadian Commercialization of ALS Drug

News provided by news direct2025-03-19

--News Direct--

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;

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, potentially like NeuroSense's PrimeC.

Some Wall Street Analysts reportedly maintain a Buy Rating for NeuroSense with AGP giving the company a $7.50 price target representing a significant premium over current Prices;

*Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This alert is published by Market News Alerts, a promotional content brand which is part of the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution is paid promotional content related to NeuroSense Therapeutics and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by NeuroSense Therapeutics prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. We are not responsible for the price targets mentioned in this article nor do we it endorse them, they are quoted based on publicly available news reports and additional or price targets may exist that may not have been quoted. Readers are advised to refer to the full reports mentioned on various systems and the disclaimers/disclosures they may be subject to.