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CAMBRIDGE, Mass. – NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a microcap biotechnology company with a market capitalization of $20.25 million, has completed a Type C pivotal meeting with the Food and Drug Administration of US (FDA) about its drug candidate. , PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS). The company’s shares have shown strong momentum with a return of 45.71% over the past year, according to data from InvestingPro. The meeting focused on the proposed design of a Phase 3 clinical study and the submission plan for a future commercialization application.
The FDA provided positive feedback on the design of the Phase 3 trial, which is a crucial step for the study to meet regulatory standards and potentially collect sufficient data for drug approval. NeuroSense plans 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 in mid-2025. Analysts maintain an optimistic outlook, with price targets ranging from 3 to 7.50 dollars, well above the current trading price of $1.02. The phase 3 trial will be randomized, multicenter, multinational, double-blind, placebo-controlled, and will have an open-label extension after 12 months of treatment.
Alon Ben-Noon, CEO of NeuroSense, said the FDA’s comments are an important milestone in its drug development program, affirming its progress and underscoring its 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 US and Europe.
ALS is an incurable condition that causes paralysis and death within 2 to 5 years after diagnosis, with more than 5,000 new cases annually in the US alone. The burden of the disease is substantial, with an estimated cost of $1 billion. dollars a year. InvestingPro’s analysis reveals the company’s aggressive investment in development, with an EBITDA of -11.69 million dollars 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 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 expenses and development 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. Additionally, 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 marketing approval for PrimeC. in Canada, taking advantage of the positive advantages. results of the phase 2b PARADIGM clinical trial. These are recent developments in the company’s operations.
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