Why Blood Components-Focused Cerus Stock Is Rising Tuesday
Why Blood Components-Focused Cerus Stock Is Rising Tuesday
Tuesday, Cerus Corporation (NASDAQ:CERS) announced topline results for the ReCePI Phase 3 trial of pathogen-reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.
週二，Cerus Corporation（納斯達克股票代碼：CERS）公佈了向複雜心臟外科患者輸注減少病原體的INTERCEPT紅細胞（INTERCEPT RBC）的Recepi三期試驗的主要結果。
The INTERCEPT Blood System for Red Blood Cells is designed to inactivate blood-borne pathogens and donor leukocytes in RBCs intended for transfusion.
INTERCEPT 紅細胞血液系統旨在滅活用於輸血的紅細胞中的血源性病原體和供體白細胞。
The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury (AKI) following transfusion of study RBCs.
該試驗達到了其主要療效終點，根據研究紅細胞輸血後的急性腎損傷（AKI）發生率來衡量，與傳統紅細胞相比，INTERCEPT紅細胞並不遜色。
AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery.
AKI 是紅細胞組織氧氣輸送的敏感輸血療效指標。
In transfused subjects, by modified intent to treat (mITT pre-specified primary endpoint population) the incidence of AKI was 29.3% (46/157) for INTERCEPT RBC recipients compared to 28.0% (45/161) for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14.0% (p = 0.001).
在輸血受試者中，根據修改後的治療意圖（MitT預先指定的主要終點群體），INTERCEPT紅細胞接受者的AKI發病率爲29.3％（46/157），而傳統紅細胞接受者的AKI發病率爲28.0％（45/161），這表明INTERCEPT紅細胞與常規紅細胞相比並不遜色，其置信區間上限爲10.4％，而非劣勢幅度爲14.0％（p = 0.001）。
The safety endpoint of the proportion of patients with any related treatment-emergent adverse events within 28 days of last transfusion was not significantly different for INTERCEPT RBCs (2.5%) compared to conventional RBCs (0.6%) (p = 0.130).
INTERCEPT紅細胞（2.5％）與傳統紅細胞（0.6％）（p = 0.130）相比，在最後一次輸血後28天內出現任何相關治療緊急不良事件的患者比例的安全終點沒有顯著差異。
"We continue to look forward to completing the RedeS clinical trial, Cerus' ongoing pivotal Phase 3 clinical trial for INTERCEPT RBCs enrolling a broader patient population requiring RBC transfusion for acute and chronic anemia," stated Richard Benjamin, Cerus' chief medical officer.
塞魯斯首席醫學官理查德·本傑明表示：“我們繼續期待完成RedES臨床試驗，這是Cerus正在進行的針對INTERCEPT紅細胞的關鍵3期臨床試驗，該試驗招收了更廣泛的急慢性貧血需要紅細胞輸血的患者群體。”
Cerus anticipates initiating a modular PMA application to the FDA in the second half of 2025, with the final PMA module submission planned for the second half of 2026 upon the anticipated completion of the RedeS clinical trial.
Cerus預計將在2025年下半年向美國食品藥品管理局啓動模塊化PMA申請，最終的PMA模塊計劃在RedES臨床試驗預計完成後於2026年下半年提交。
Price Action: CERS shares are up 3.23% at $1.91 on the last check Tuesday.
價格走勢：在週二的最後一次支票中，CERS股價上漲3.23％，至1.91美元。
Photo by Narupon Promvichai from Pixabay
照片由 Pixabay 上的 Narupon Promvichai 拍攝