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.
週五，PaxMedica Inc（納斯達克股票代碼：PXMD）完成了其三批關鍵註冊/驗證批次 PAX-101（舒拉明靜脈注射配方）的執行。
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.
這一成就是促成向美國食品藥品管理局提交新藥申請（目前計劃於2024年第四季度提交）的重要里程碑，以及第一種也是唯一一種用於第一階段非洲人類錐蟲病（HAT）的舒拉明有可能在美國商業上市，該病是由布魯氏錐蟲引起的，如果獲得美國食品藥品管理局批准，這是一種致命的、被忽視的熱帶病。
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.
根據疾病預防控制中心的說法，達到這一里程碑對PaxMedica可能獲得美國食品藥品管理局批准 PAX-101 至關重要，是目前美國以外公認的最致命的HAT病因的治療標準。
A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV).
成功審查和批准保密協議可能進一步使公司有資格獲得熱帶病優先審查憑證（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 計劃爲 PAX-101 的可持續全球供應鏈提供資金，並進一步推進研究和臨床試驗，以解決自閉症譜系障礙。
"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董事長兼首席執行官霍華德·韋斯曼表示：“對於PaxMedica來說，這是一個非常重要的里程碑，因爲它正在努力推動 PAX-101 提交保密協議。“PaxMedica 的長期願景是進一步研究 PAX-101 作爲自閉症譜系障礙患者的治療方法。”
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 發佈了 PAX-HAT-301 蘇拉明治療第 1 期布魯西羅德西亞人類非洲錐蟲病（S1 TBR HAT）的回顧性分析的頭條數據。
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.
研究結果證實，與1900-1910年間在舒拉明在非洲上市之前評估和治療的自然史對照組患者相比，在第一階段TBR HAT治療中服用的舒拉明可改善健康狀況。
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.
在接受蘇拉明治療的患者中，有94％存活並完成了治療，而在自然史隊列中，只有14％被記錄爲治癒、改善或出院。
Price Action: PXMD shares are up 106.40% at $0.85 on the last check Friday.
價格走勢：週五的最後一次支票中，PXMD股價上漲106.40％，至0.85美元。
Photo by hans-reniers for Unsplash
由 hans-reniers 爲 Unsplash 拍攝的照片
譯文內容由第三人軟體翻譯。