Penny Stock PaxMedica's African Sleeping Sickness Candidate Moves Closer To FDA Marketing Application Submission, Stock Rallies
Penny Stock PaxMedica's African Sleeping Sickness Candidate Moves Closer To FDA Marketing Application Submission, Stock Rallies
Friday, PaxMedica Inc (NASDAQ:PXMD) completed the execution of its three pivotal registration/validation batches of PAX-101, an IV formulation of suramin.
周五，PaxMedica Inc（纳斯达克股票代码：PXMD）完成了其三批关键注册/验证批次 PAX-101（舒拉明静脉注射配方）的执行。
This achievement is an essential milestone in enabling a New Drug Application submission to the FDA, which is currently planned for Q4 2024, and the potential commercial availability in the U.S. of the first and only form of suramin for Stage 1 Human African Trypanosomiasis (HAT), caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease if approved by the FDA.
这一成就是促成向美国食品药品管理局提交新药申请（目前计划于2024年第四季度提交）的重要里程碑，以及第一种也是唯一一种用于第一阶段非洲人类锥虫病（HAT）的舒拉明有可能在美国商业上市，该病是由布鲁氏锥虫引起的，如果获得美国食品药品管理局批准，这是一种致命的、被忽视的热带病。
According to the CDC, reaching this milestone is critical to PaxMedica's journey toward potential FDA approval for PAX-101, currently the accepted standard of treatment outside the United States for the deadliest cause of HAT.
根据疾病预防控制中心的说法，达到这一里程碑对PaxMedica可能获得美国食品药品管理局批准 PAX-101 至关重要，是目前美国以外公认的最致命的HAT病因的治疗标准。
A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV).
成功审查和批准保密协议可能进一步使公司有资格获得热带病优先审查凭证（PRV）。
PaxMedica plans to fund a sustainable global supply chain for PAX-101 and further advance research and clinical trials to address Autism Spectrum Disorder.
PaxMedica 计划为 PAX-101 的可持续全球供应链提供资金，并进一步推进研究和临床试验，以解决自闭症谱系障碍。
"This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission," said Howard Weisman, chairman and CEO of PaxMedica. "The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with Autism Spectrum Disorder."
PaxMedica董事长兼首席执行官霍华德·韦斯曼表示：“对于PaxMedica来说，这是一个非常重要的里程碑，因为它正在努力推动 PAX-101 提交保密协议。“PaxMedica 的长期愿景是进一步研究 PAX-101 作为自闭症谱系障碍患者的治疗方法。”
In July 2023, PaxMedica released topline data from PAX-HAT-301 Retrospective Analysis of Suramin Treatment for Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT).
2023 年 7 月，PaxMedica 发布了 PAX-HAT-301 苏拉明治疗第 1 期布鲁西罗德西亚人类非洲锥虫病（S1 TBR HAT）的回顾性分析的头条数据。
The study findings affirm that suramin, administered in the treatment of Stage 1 TBR HAT, resulted in improved health outcomes compared to a natural history control group of patients assessed and treated between 1900-1910 before suramin became available in Africa.
研究结果证实，与1900-1910年间在舒拉明在非洲上市之前评估和治疗的自然史对照组患者相比，在第一阶段TBR HAT治疗中服用的舒拉明可改善健康状况。
Among the suramin-treated patients, 94% survived and completed the treatment, while in the natural history cohort, only 14% were recorded as cured, improved, or discharged.
在接受苏拉明治疗的患者中，有94％存活并完成了治疗，而在自然史队列中，只有14％被记录为治愈、改善或出院。
Price Action: PXMD shares are up 106.40% at $0.85 on the last check Friday.
价格走势：周五的最后一次支票中，PXMD股价上涨106.40％，至0.85美元。
Photo by hans-reniers for Unsplash
由 hans-reniers 为 Unsplash 拍摄的照片