Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant, Stock Surges
Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant, Stock Surges
The analysis compared overall survival in the 28 TA-TMA patients in OMS721-TMA-001, Omeros' previously conducted pivotal trial for narsoplimab in TA-TMA, to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of HSCT patients who did not receive narsoplimab treatment.On Thursday, Omeros Corporation (NASDAQ:OMER) announced that an independent statistical group has completed the primary statistical analysis agreed with the FDA for narsoplimab.
上週四，奧麥羅製藥（納斯達克：OMER）宣佈，一個獨立統計小組已完成與FDA達成一致的narsoplimab的主要統計分析。
Omeros is a first-in-class monoclonal antibody that inhibits the lectin pathway of complement in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
奧麥羅製藥是一種首創單克隆抗體，可抑制造血幹細胞移植相關血栓性微血管病（TA-TMA）中的凝集素通路。
TA-TMA is a complication in adult and pediatric hematopoietic stem cell transplantation (HSCT).
TA-TMA是成人和兒童造血幹細胞移植（HSCT）中的一種併發症。
The analysis compared overall survival in the 28 TA-TMA patients in OMS721-TMA-001, Omeros' previously conducted pivotal trial for narsoplimab in TA-TMA, to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of HSCT patients who did not receive narsoplimab treatment.
該分析比較了28名TA-TMA患者在OMS721-TMA-001試驗中的整體生存率，奧麥羅製藥此前進行的narsoplimab在TA-TMA中的關鍵試驗，超過100名未接受narsoplimab治療的高風險TA-TMA患者在外部對照註冊中的整體生存率。
Narsoplimab met its primary endpoint, with OMS721-TMA-001 patients demonstrating clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 compared to the TA-TMA registry patients.
narsoplimab達到了其主要終點，OMS721-TMA-001的患者在整體生存率上表現出臨床意義和統計學顯著的優越性——與TA-TMA註冊患者相比，風險比爲0.32。
Late last month, Omeros announced that it had received FDA's recommendations on the statistical analysis plan (SAP) for the primary analysis comparing overall survival from the time of first dosing in the 28 narsoplimab-treated TA-TMA patients in the pivotal trial OMS721-TMA-001 to overall survival, adjusted for immortal time bias, of the more than 100 TA-TMA patients in the external control registry, none of whom received narsoplimab.
上個月底，奧麥羅製藥宣佈已收到FDA關於主要分析的統計分析計劃（SAP）的建議，該分析比較了在關鍵試驗OMS721-TMA-001中28名接受narsoplimab治療的TA-TMA患者的生存率，以及在外部對照註冊中超過100名未接受narsoplimab的TA-TMA患者的生存率，已對不朽時間偏倚進行了調整。
To date, narsoplimab has been well tolerated and has shown no safety signal of concern across all its clinical trials in various indications.
迄今爲止，narsoplimab的耐受性良好，在各類適應症的所有臨床試驗中均未出現安全性擔憂的信號。
Given the primary analysis results, we will resubmit the narsoplimab BLA for TA-TMA as quickly as possible, followed by our planned submission of the corresponding European marketing authorization application in the second quarter of 2025.
鑑於主要分析結果，我們將盡快重新提交narsoplimab的TA-TMA生物製劑許可申請，隨後計劃在2025年第二季度提交相應的歐洲市場授權申請。
Additional sensitivity and other analyses are pending and should be available over the next few weeks.
額外的敏感性和其他分析仍在進行中，預計在接下來的幾周內可以獲得。
Price Action: OMER stock is up 54.8% at $11.55 at last check Thursday.
價格走勢：奧麥羅製藥股票在週四最後一次檢查時上漲了54.8%，報11.55美元。
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譯文內容由第三人軟體翻譯。
