Moleculin: MIRACLE Part A, 환자 90명 대상 비맹검 결과 2026년 12월~2027년 2월 발표 예정

Positive interim data from the first 45 patients in Part A showed CR rates at least three times higher than control. The trial is on track to complete 90-patient enrollment in September 2026, with the unblinded efficacy readout scheduled for December 2026 to February 2027 to support optimal-dose selection and Part B initiation in 1H 2027.

핵심 사실

제출: 2026년 8월 14일 오후 12:30
이벤트: 탑라인 결과
방향: 긍정적
기업: MBRXMoleculin Biotech, Inc.
자산: naxtarubicin
출처: SEC 8-K
신뢰도: 출처 확인
CR율: 30%
CRh율: 10%
눈가림 CRc율: 40%
분석 피험자: 30명
venetoclax 실패: 약 35%

출처 발췌

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