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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 ·  2024/09/24 08:26

Moomoo AI 已提取核心信息

NeuroSense Therapeutics announced two significant developments on September 24, 2024. The company regained compliance with Nasdaq's minimum bid price requirement by maintaining a closing bid price above $1.00 for 10 consecutive business days. Additionally, the USPTO granted a key patent for PrimeC, their lead ALS treatment candidate, extending patent protection until 2042.The new patent covers PrimeC's novel formulation combining ciprofloxacin and celecoxib in a slow-release technology that synchronizes their pharmacokinetic profiles. Recent clinical findings showed PrimeC reduced ALS disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Phase 2b PARADIGM trial demonstrated a 29% difference in efficacy versus placebo in the ITT population.The company is preparing to initiate Phase 3 trials in the US for PrimeC, which has received Orphan Drug Designation from both FDA and EMA. The drug's innovative approach targets multiple ALS mechanisms, including motor neuron degeneration, inflammation, iron accumulation, and RNA regulation impairment.
NeuroSense Therapeutics announced two significant developments on September 24, 2024. The company regained compliance with Nasdaq's minimum bid price requirement by maintaining a closing bid price above $1.00 for 10 consecutive business days. Additionally, the USPTO granted a key patent for PrimeC, their lead ALS treatment candidate, extending patent protection until 2042.The new patent covers PrimeC's novel formulation combining ciprofloxacin and celecoxib in a slow-release technology that synchronizes their pharmacokinetic profiles. Recent clinical findings showed PrimeC reduced ALS disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Phase 2b PARADIGM trial demonstrated a 29% difference in efficacy versus placebo in the ITT population.The company is preparing to initiate Phase 3 trials in the US for PrimeC, which has received Orphan Drug Designation from both FDA and EMA. The drug's innovative approach targets multiple ALS mechanisms, including motor neuron degeneration, inflammation, iron accumulation, and RNA regulation impairment.
NeuroSense Therapeutics在2024年9月24日宣布了两项重要进展。该公司通过在连续10个业务日内保持收盘买盘价高于1.00美元，重新符合纳斯达克的最低买盘价要求。此外，USPTO授予了PrimeC，作为其主要ALS治疗候选药物的关键专利，延长了专利保护至2042年。新专利涵盖了PrimeC的新型配方，该配方结合了环丙沙星和塞来昔布，并采用缓释科技，使其药代动力学特征同步。最近的临床研究结果显示，PrimeC将ALS疾病进展降低了36%（p=0.009），并且与安慰剂相比，生存率提高了43%。20亿PARADIGm试验在ITt人群中显示出与安慰剂相比的疗效差异为29%。该公司正在准备在美国启动PrimeC的第三阶段试验，该药物已获得FDA和EMA的孤儿药资格。该药物的创新方法针对多种ALS机制，包括运动神经元退化、炎症、铁积累和RNA调控损伤。
NeuroSense Therapeutics在2024年9月24日宣布了两项重要进展。该公司通过在连续10个业务日内保持收盘买盘价高于1.00美元，重新符合纳斯达克的最低买盘价要求。此外，USPTO授予了PrimeC，作为其主要ALS治疗候选药物的关键专利，延长了专利保护至2042年。新专利涵盖了PrimeC的新型配方，该配方结合了环丙沙星和塞来昔布，并采用缓释科技，使其药代动力学特征同步。最近的临床研究结果显示，PrimeC将ALS疾病进展降低了36%（p=0.009），并且与安慰剂相比，生存率提高了43%。20亿PARADIGm试验在ITt人群中显示出与安慰剂相比的疗效差异为29%。该公司正在准备在美国启动PrimeC的第三阶段试验，该药物已获得FDA和EMA的孤儿药资格。该药物的创新方法针对多种ALS机制，包括运动神经元退化、炎症、铁积累和RNA调控损伤。
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