Moleculin: MIRACLE Part A 90名患者非盲读出 Dec 2026–Feb 2027

A部分前45名患者的积极中期数据显示CR率至少是对照组的三倍。试验正按计划于2026年9月完成90名患者入组，非盲疗效读出定于2026年12月至2027年2月，以支持最佳剂量选择和Part B于1H 2027启动。

关键事实

申报时间: 2026年8月14日 12:30
事件: 顶线结果
方向: 积极
公司: MBRXMoleculin Biotech, Inc.
资产: naxtarubicin
来源: SEC 8-K
可信度: 有来源
完全缓解率: 30%
完全缓解伴血液学改善率: 10%
盲法完全缓解伴细胞遗传学改善率: 40%
分析受试者: 30 例
venetoclax 失败: ~35%

来源摘录

EX-99.1 2 ex_1004839.htm EXHIBIT 99.1 ex_1004839.htm Exhibit 99.1 Moleculin Biotech Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of Pivotal MIRACLE Trial - Positive interim MIRACLE data showed complete remission rates three times higher than control in relapsed/refractory AML - MIRACLE trial advancing toward planned 90-patient enrollment milestone in September 2026 with the unblinded efficacy readout in December 2026 to February 2027 timeframe - MIRACLE trial Part B initiation expected in the first half of 2027 following optimal dose selection - Cash position, including $9.3 million raised after quarter-end, expected to fund operations into the first quarter of 2027 - Absence of cardiotoxicity continues in the MIRACLE trial HOUSTON, August 14,

SEC 8-K