CAMBRIDGE, Mass. - NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a micro-cap biotech firm with a market capitalization of $20.25 million, has completed a pivotal Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its drug candidate, PrimeC, for amyotrophic lateral sclerosis (ALS) treatment. The company's stock has shown strong momentum with a 45.71% return over the past year, according to InvestingPro data. The meeting focused on the proposed design of a Phase 3 clinical study and the submission plan for a future marketing application.
The FDA provided positive feedback on the Phase 3 trial design, which is a crucial step for the study to meet regulatory standards and potentially gather sufficient data for drug approval. NeuroSense is planning to submit the 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 an optimistic outlook, with price targets ranging from $3 to $7.50, significantly above the current trading price of $1.02. The Phase 3 trial will be randomized, multi-center, multinational, double-blind, and placebo-controlled, featuring an open label extension after 12 months of treatment.
Alon Ben-Noon, CEO of NeuroSense, stated that the FDA's feedback is a significant milestone in their drug development program, affirming their progress and underscoring their commitment to advancing treatment options for ALS patients.
Previously, NeuroSense completed the PARADIGM Phase 2b clinical trial, which demonstrated that PrimeC could 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 U.S. and Europe.
ALS is an incurable condition leading to paralysis and death within 2-5 years of diagnosis, with over 5,000 new cases annually in the U.S. alone. The burden of the disease is substantial, with an estimated cost of $1 billion per year. InvestingPro analysis reveals the company's aggressive investment in development, with an EBITDA of -$11.69 million in the last twelve months. Get access to 5 additional ProTips and comprehensive financial metrics to better understand NeuroSense's development trajectory and market potential.
This article is based on a press release statement 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. has secured a $5 million private placement agreement 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 ending December 31, 2023, ending the year with approximately $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 dossier to Health Canada in the second quarter of 2025. The company is also seeking early commercialization approval for PrimeC in Canada, leveraging positive results from the Phase 2b PARADIGM clinical trial. These are recent developments in the company's operations.
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