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6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

6-K:外国发行人报告
美股SEC公告 ·  10/15 21:39

Moomoo AI 已提取核心信息

NeuroSense Therapeutics Ltd., a late-clinical stage biotech company, announced on October 15, 2024, its plans for early commercialization of its ALS treatment, PrimeC, in Canada. The company is preparing to submit a dossier for regulatory approval in Q2 2025, with a decision expected by Q1 2026. This follows promising results from the Phase 2b ALS PARADIGM clinical trial and additional data. NeuroSense is targeting a significant market opportunity in Canada, estimating peak annual revenues between $100M to $150M. The company also plans to seek approval in other global markets. PrimeC has shown to significantly reduce disease progression and improve survival rates in clinical trials. The drug is a combination of ciprofloxacin and celecoxib, designed to target multiple mechanisms of ALS. NeuroSense has received Orphan Drug Designation for PrimeC from both the FDA and the European Medicines Agency. The company's broader strategy is to address the unmet medical needs in neurodegenerative diseases and drive sustainable growth.
NeuroSense Therapeutics Ltd., a late-clinical stage biotech company, announced on October 15, 2024, its plans for early commercialization of its ALS treatment, PrimeC, in Canada. The company is preparing to submit a dossier for regulatory approval in Q2 2025, with a decision expected by Q1 2026. This follows promising results from the Phase 2b ALS PARADIGM clinical trial and additional data. NeuroSense is targeting a significant market opportunity in Canada, estimating peak annual revenues between $100M to $150M. The company also plans to seek approval in other global markets. PrimeC has shown to significantly reduce disease progression and improve survival rates in clinical trials. The drug is a combination of ciprofloxacin and celecoxib, designed to target multiple mechanisms of ALS. NeuroSense has received Orphan Drug Designation for PrimeC from both the FDA and the European Medicines Agency. The company's broader strategy is to address the unmet medical needs in neurodegenerative diseases and drive sustainable growth.
神经感知治疗有限公司,一家处于晚期临床阶段的生物科技公司,于2024年10月15日宣布了其在加拿大早期商业化其ALS治疗药物PrimeC的计划。该公司正准备在2025年第二季度提交监管批准的档案,预计在2026年第一季度做出决定。这是根据第20亿ALS PARADIGm临床试验和额外数据显示有希望的结果。神经感知公司瞄准了加拿大的重要市场机会,估计最高年收入介于1亿到1.5亿美元之间。该公司还计划在其他全球市场寻求批准。PrimeC在临床试验中显示出明显减少疾病进展并提高生存率的效果。这种药物是环丙沙星和美洛昔康的复合物,旨在针对ALS的多种机制。神经感知已从FDA和欧洲药品管理局获得PrimeC孤儿药品认定。该公司更广泛的策略是解决神经退行性疾病中未满足的医疗需求,并推动可持续增长。
神经感知治疗有限公司,一家处于晚期临床阶段的生物科技公司,于2024年10月15日宣布了其在加拿大早期商业化其ALS治疗药物PrimeC的计划。该公司正准备在2025年第二季度提交监管批准的档案,预计在2026年第一季度做出决定。这是根据第20亿ALS PARADIGm临床试验和额外数据显示有希望的结果。神经感知公司瞄准了加拿大的重要市场机会,估计最高年收入介于1亿到1.5亿美元之间。该公司还计划在其他全球市场寻求批准。PrimeC在临床试验中显示出明显减少疾病进展并提高生存率的效果。这种药物是环丙沙星和美洛昔康的复合物,旨在针对ALS的多种机制。神经感知已从FDA和欧洲药品管理局获得PrimeC孤儿药品认定。该公司更广泛的策略是解决神经退行性疾病中未满足的医疗需求,并推动可持续增长。
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