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CAMBRIDGE, Mass. – NeuroSense Therapeutics Ltd. (NASDAQ: NRSN ), a $20.25 million market cap micro-cap biotech firm, has completed a pivotal Type C meeting with the U.S. Food and Drug Administration (FDA) for its drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis. lateral sclerosis (ALS). The company’s stock has shown strong momentum with a return of 45.71% over the past year, according to InvestingPro data. The meeting focused on the proposed Phase 3 clinical study design and submission plan for a future marketing application.
The FDA gave positive feedback on the Phase 3 trial design, a key step for the study to meet regulatory standards and potentially gather enough data to approve the drug. NeuroSense plans to submit a final protocol to the FDA in the first half of 2025 and aims to begin enrolling approximately 300 patients in the study by mid-2025. Analysts maintain a bullish outlook, with price targets ranging from $3 to $7.50, well above the current trading price of $1.02. The phase 3 trial will be a randomized, multicenter, multinational, double-blind, placebo-controlled, open-label extension after 12 months of treatment.
Alon Ben-Noon, CEO of NeuroSense, said the FDA’s feedback is a significant milestone in their drug development program, confirming their progress and underscoring their commitment to advancing treatment options for ALS patients.
Previously, NeuroSense completed the PARADIGM Phase 2b clinical trial, which showed that PrimeC can significantly slow disease progression and increase survival rates in ALS patients. PrimeC, an extended-release oral formulation combining ciprofloxacin and celecoxib, targets multiple mechanisms associated with ALS and has received orphan drug designation in the US and Europe.
ALS is an incurable condition that leads to paralysis and death within 2-5 years of diagnosis, with over 5,000 new cases per year in the US alone. The burden of disease is significant, with estimated costs of $1 billion annually. InvestingPro analysis reveals the company’s aggressive investment in development, with an EBITDA of -$11.69 million over the last twelve months. Get access to 5 additional tips and comprehensive financial metrics to better understand NeuroSense’s development trajectory and market potential.
This article is based on a press release from NeuroSense Therapeutics. The information provided reflects the company’s current expectations and involves risks and uncertainties that could cause actual results to differ materially.
In other recent news, NeuroSense Therapeutics Ltd. secured a $5 million private placement deal and extended patent protection for its ALS treatment, PrimeC, through 2042. The company also reported an 18% increase in research and development expenses and a 20% decrease in general and administrative expenses for the year ends December 31, 2023, ending the year with approx $2.6 million in cash. In addition, NeuroSense has scheduled an FDA meeting to finalize the Phase 3 study design for PrimeC and plans to submit a regulatory filing to Health Canada in the second quarter of 2025. The company is also seeking early approval to commercialize PrimeC in Canada, leveraging positive Phase 3 clinical trial results 2b PARADIGM. These are recent developments in the company’s operations.
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