- In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression - The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM - These results are the first prospective, longitudinal evaluation of cardiac structure and function by CMR imaging in a double-blind, placebo-controlled, interventional study in ATTR-CM - The findings from this study build upon positive results from BridgeBio’s global ATTRibute-CM Phase 3 trial, wherein the primary endpoint was met (Win Ratio of 1.8) with a high statistical significance (p<0.0001); the substudy data are consistent with the cardiovascular clinical benefits observed with acoramidis - Acoramidis was well-tolerated, with no safety signals of potential clinical concern observed - BridgeBio’s New Drug Application (NDA) has been accepted by the U.S.

-在这项探索性亚研究中，与安慰剂相比，使用阿科拉米司治疗可能会改善心脏结构和功能，并可能导致心脏淀粉样蛋白消退-数据表明，使用阿科拉米司靶向接近完全的运甲状腺素蛋白（TTR）稳定可能会使ATTR-CM患者的心脏重塑和功能恢复-这些结果是ATTR-CM双盲、安慰剂对照、介入研究中首次通过CMR成像对心脏结构和功能进行前瞻性纵向评估-这项研究的结果建立在BridgeBio全球属性CM 3期试验的积极结果基础上，其中主要终点得到满足（赢率为1.8），具有很高的统计学意义（p<0.0001））；亚组研究数据与用acoramidis观察到的心血管临床益处一致-acoramidis耐受性良好，没有观察到潜在临床问题的安全信号-BridgeBio的新药申请（NDA）已被美国接受。

Food and Drug Administration (FDA) with a PDUFA action date of November 29, 2024; a Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA), with an expected decision in 2025 PALO ALTO, Calif., April 07, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc.

食品和药物管理局（FDA），PDUFA行动日期为2024年11月29日；欧洲药品管理局（EMA）已接受acoramidis的上市授权申请（MAA），预计2025年将于2024年4月7日在加利福尼亚州帕洛阿尔托（Global NEWSWIRE）——BridgeBio Pharma，Inc.做出决定。

(Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today presented results from the exploratory CMR imaging substudy of ATTRibute-CM, its Phase 3 trial of acoramidis in ATTR-CM. These data were presented at the American College of Cardiology (ACC) Annual Scientific Sessions & Expo in a moderated poster session by Yousef Razvi, M.D.

（Nasdaq:BBIO）（“BridgeBio”或“公司”）是一家专注于遗传疾病和癌症的商业阶段生物制药公司，今天介绍了ATTRibute CM的探索性CMR成像子研究的结果，ATTRibute CM是其在ATTR-CM中对acoramidis进行的3期试验。这些数据在美国心脏病学会（ACC）年度科学会议和博览会上由医学博士Yousef Razvi主持的海报会议上发布。

of University College Lo.

Lo大学学院。