EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission
EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission
NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements.NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS).
NeuroSense Therapeutics Ltd.（纳斯达克：NRSN）周一表示，计划进行FDA类型C会议，讨论其即将开展的PrimeC第3期临床试验的设计，PrimeC是治疗肌萎缩侧索硬化（ALS）的潜在疗法。
ALS is a fatal type of motor neuron disease. It causes progressive degeneration of nerve cells in the spinal cord and brain.
ALS是一种致命的运动神经元疾病，导致脊髓和大脑中神经细胞的进行性退化。
The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug.
FDA类型C会议定于11月6日举行，将重点确定第3期试验的设计，这是获得药物批准的关键一步。
NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements.
NeuroSense还将审查其未来新药申请（NDA）提交的准备情况，确保其监管策略符合FDA的要求。
NeuroSense plans to give an update on the meeting results following receipt of the meeting minutes, which are expected approximately one month after the meeting.
NeuroSense计划在收到会议纪要后宣布会议结果，预计该纪要在会后大约一个月内收到。
PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in clinical and biological markers of disease progression.
NeuroSense的主打产品PrimeC在临床试验中展现出了有希望的结果，包括在临床和生物标志物上疾病进展的统计显著减少。
In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026.
同时，NeuroSense计划于2025年第二季度向加拿大卫生部提交其监管文件，预计在2026年第一季度获得监管决定。
The company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue.
该公司估计PrimeC在加拿大市场的潜在机会年营业收入约为10000万至15000万美元。
The decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.
该决定遵循了加拿大监管专家的建议和最近的临床研究结果，这些研究表明PrimeC显著减少了疾病进展（p=0.009），并将生存率提高了43%，与安慰剂相比。
In August, NeuroSense Therapeutics said it was in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize PrimeC.
NeuroSense Therapeutics在八月份表示，他们正在与几家市值数十亿美元的药品公司展开深入讨论，商谈潜在的PrimeC开发和商业化战略合作事宜。
In July, 12-month data of the PARADIGM Phase 2b study showed a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo.
7月，PARADIGm第20亿期研究的12个月数据显示，在开始试验时接受PrimeC的受试对象与接受安慰剂的受试对象相比，ALS功能评定量表-修订版得分下降的速度有显著改善，生存率也有所提高。
Specifically, the intent to treat analysis at 12 months revealed a difference of 6.5 points in the ALSFRS-R, representing a 36% improvement and a statistically significant P value of 0.009.
具体而言，12个月意向治疗分析显示ALSFRS-R的差异为6.5分，表示改善了36%，P值达到显著水平（0.009）。
Price Action: NRSN stock is down 5.51% at $1.20 during the premarket session at last check Monday.
价格走势：NRSN股票在周一最后一次查询时，在盘前交易会话中下跌了5.51%，报价为1.20美元。
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