[8-K] Moleculin Biotech, Inc. Reports Material Event
Moleculin Biotech announced updates to its pivotal Phase 2B/3 trial ("MIRACLE") evaluating Annamycin combined with cytarabine ("AnnAraC") for adults with relapsed or refractory acute myeloid leukemia (R/R AML). The company reported active site status and recruitment updates for the multi-center, randomized, double-blind, placebo-controlled, adaptive-design study. The MIRACLE trial is described as a global approval trial with sites in the U.S., Europe and the Middle East. A press release providing these trial updates is attached to the report as Exhibit 99.1 and is furnished with the filing.
Moleculin Biotech ha comunicato aggiornamenti sul suo trial pivotale di fase 2B/3 ("MIRACLE") che valuta Annamycin in combinazione con citarabina ("AnnAraC") per adulti con leucemia mieloide acuta recidivante o refrattaria (R/R AML). La società ha reso noti lo stato dei siti attivi e gli aggiornamenti sul reclutamento per questo studio multicentrico, randomizzato, in doppio cieco, controllato con placebo e a disegno adattativo. Il trial MIRACLE è presentato come uno studio globale per l'approvazione, con siti negli Stati Uniti, in Europa e in Medio Oriente. Un comunicato stampa contenente questi aggiornamenti è allegato al rapporto come Exhibit 99.1 ed è fornito con il deposito.
Moleculin Biotech anunció actualizaciones de su ensayo pivotal de fase 2B/3 ("MIRACLE") que evalúa Annamycin combinado con citarabina ("AnnAraC") en adultos con leucemia mieloide aguda recidivante o refractaria (R/R AML). La compañía informó sobre el estado de los sitios activos y avances en la incorporación de pacientes para este estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de diseño adaptativo. El ensayo MIRACLE se presenta como un estudio global de aprobación, con centros en EE. UU., Europa y Oriente Medio. Un comunicado de prensa con estas actualizaciones del ensayo figura adjunto al informe como Exhibit 99.1 y se proporciona con la presentación.
Moleculin Biotech는 재발성 또는 불응성 급성 골수성 백혈병(R/R AML) 성인 환자 대상 Annamycin과 시타라빈 병용(“AnnAraC”)을 평가하는 중추적 2B/3상 시험("MIRACLE")에 대한 업데이트를 발표했습니다. 회사는 다기관, 무작위배정, 이중맹검, 위약대조, 적응설계 연구의 활성 사이트 현황 및 모집 진행 상황을 보고했습니다. MIRACLE 임상시험은 미국, 유럽 및 중동에 사이트를 둔 글로벌 승인용 시험으로 설명됩니다. 이 시험 업데이트를 담은 보도자료가 보고서의 Exhibit 99.1로 첨부되어 제출되었습니다.
Moleculin Biotech a annoncé des mises à jour concernant son essai pivot de phase 2B/3 ("MIRACLE") évaluant Annamycin associé à la cytarabine ("AnnAraC") chez des adultes atteints de leucémie myéloïde aiguë récurrente ou réfractaire (R/R AML). La société a communiqué l'état des sites actifs et les avancées du recrutement pour cette étude multicentrique, randomisée, en double aveugle, contrôlée par placebo et en plan adaptatif. L'essai MIRACLE est présenté comme un essai d'approbation à l'échelle mondiale, avec des sites aux États‑Unis, en Europe et au Moyen‑Orient. Un communiqué de presse contenant ces mises à jour est joint au rapport en tant qu'Exhibit 99.1 et est fourni avec le dépôt.
Moleculin Biotech kündigte Aktualisierungen zu seiner wegweisenden Phase‑2B/3‑Studie ("MIRACLE") an, die Annamycin in Kombination mit Cytarabin ("AnnAraC") bei Erwachsenen mit rezidivierter oder refraktärer akuter myeloischer Leukämie (R/R AML) prüft. Das Unternehmen berichtete über den Status aktiver Studienzentren und den Stand der Patientenrekrutierung für diese multizentrische, randomisierte, doppelblinde, placebokontrollierte, adaptiv designte Studie. Die MIRACLE‑Studie wird als globale Zulassungsstudie mit Standorten in den USA, Europa und dem Nahen Osten beschrieben. Eine Pressemitteilung mit diesen Studien‑Updates ist dem Bericht als Exhibit 99.1 beigefügt und mit der Einreichung eingereicht worden.
- Operational progress reported with active site status and recruitment updates for the pivotal trial
- Robust trial design: randomized, double-blind, placebo-controlled, adaptive Phase 2B/3 intended as a global approval study
- Global footprint explicitly includes sites in the U.S., Europe and the Middle East
- No enrollment numbers, timelines, or interim efficacy/safety data provided
- No regulatory submission timing or specific primary endpoint information disclosed
- Financial impact is unspecified; the filing contains no financials or material commercial metrics
Insights
TL;DR: Company reports operational progress in a global pivotal Phase 2B/3 adaptive trial of Annamycin with Ara-C for R/R AML.
The filing provides an operational update confirming active site status and recruitment activity for a multi-center, randomized, double-blind, placebo-controlled adaptive-design study. This design and global footprint (U.S., Europe, Middle East) are appropriate for seeking broad regulatory approvals if the trial meets endpoints. The disclosure, however, contains no enrollment figures, timelines, interim results, or safety/efficacy data, limiting near-term interpretability of clinical risk or probability of success.
TL;DR: The trial's global, adaptive Phase 2B/3 structure supports regulatory engagement but the filing supplies only procedural updates.
An adaptive, randomized, placebo-controlled pivotal study is aligned with regulatory expectations for a global approval pathway. Inclusion of multiple regions suggests intent to support submissions in several jurisdictions. The report merely references site activation and recruitment updates via an attached press release; there is no regulatory filing, endpoint description, or timeline disclosed here to assess regulatory milestones or filing strategy.
Moleculin Biotech ha comunicato aggiornamenti sul suo trial pivotale di fase 2B/3 ("MIRACLE") che valuta Annamycin in combinazione con citarabina ("AnnAraC") per adulti con leucemia mieloide acuta recidivante o refrattaria (R/R AML). La società ha reso noti lo stato dei siti attivi e gli aggiornamenti sul reclutamento per questo studio multicentrico, randomizzato, in doppio cieco, controllato con placebo e a disegno adattativo. Il trial MIRACLE è presentato come uno studio globale per l'approvazione, con siti negli Stati Uniti, in Europa e in Medio Oriente. Un comunicato stampa contenente questi aggiornamenti è allegato al rapporto come Exhibit 99.1 ed è fornito con il deposito.
Moleculin Biotech anunció actualizaciones de su ensayo pivotal de fase 2B/3 ("MIRACLE") que evalúa Annamycin combinado con citarabina ("AnnAraC") en adultos con leucemia mieloide aguda recidivante o refractaria (R/R AML). La compañía informó sobre el estado de los sitios activos y avances en la incorporación de pacientes para este estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de diseño adaptativo. El ensayo MIRACLE se presenta como un estudio global de aprobación, con centros en EE. UU., Europa y Oriente Medio. Un comunicado de prensa con estas actualizaciones del ensayo figura adjunto al informe como Exhibit 99.1 y se proporciona con la presentación.
Moleculin Biotech는 재발성 또는 불응성 급성 골수성 백혈병(R/R AML) 성인 환자 대상 Annamycin과 시타라빈 병용(“AnnAraC”)을 평가하는 중추적 2B/3상 시험("MIRACLE")에 대한 업데이트를 발표했습니다. 회사는 다기관, 무작위배정, 이중맹검, 위약대조, 적응설계 연구의 활성 사이트 현황 및 모집 진행 상황을 보고했습니다. MIRACLE 임상시험은 미국, 유럽 및 중동에 사이트를 둔 글로벌 승인용 시험으로 설명됩니다. 이 시험 업데이트를 담은 보도자료가 보고서의 Exhibit 99.1로 첨부되어 제출되었습니다.
Moleculin Biotech a annoncé des mises à jour concernant son essai pivot de phase 2B/3 ("MIRACLE") évaluant Annamycin associé à la cytarabine ("AnnAraC") chez des adultes atteints de leucémie myéloïde aiguë récurrente ou réfractaire (R/R AML). La société a communiqué l'état des sites actifs et les avancées du recrutement pour cette étude multicentrique, randomisée, en double aveugle, contrôlée par placebo et en plan adaptatif. L'essai MIRACLE est présenté comme un essai d'approbation à l'échelle mondiale, avec des sites aux États‑Unis, en Europe et au Moyen‑Orient. Un communiqué de presse contenant ces mises à jour est joint au rapport en tant qu'Exhibit 99.1 et est fourni avec le dépôt.
Moleculin Biotech kündigte Aktualisierungen zu seiner wegweisenden Phase‑2B/3‑Studie ("MIRACLE") an, die Annamycin in Kombination mit Cytarabin ("AnnAraC") bei Erwachsenen mit rezidivierter oder refraktärer akuter myeloischer Leukämie (R/R AML) prüft. Das Unternehmen berichtete über den Status aktiver Studienzentren und den Stand der Patientenrekrutierung für diese multizentrische, randomisierte, doppelblinde, placebokontrollierte, adaptiv designte Studie. Die MIRACLE‑Studie wird als globale Zulassungsstudie mit Standorten in den USA, Europa und dem Nahen Osten beschrieben. Eine Pressemitteilung mit diesen Studien‑Updates ist dem Bericht als Exhibit 99.1 beigefügt und mit der Einreichung eingereicht worden.
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))
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Regulation FD Disclosure
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Exhibit
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Description
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Press Releasedated September 9, 2025
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104
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MOLECULIN BIOTECH, INC.
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Date:
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September 9, 2025
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/s/ Jonathan P. Foster
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Jonathan P. Foster
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FAQ
What did Moleculin Biotech (MBRX) report in this 8-K?
What is the design of the MIRACLE trial mentioned by MBRX?
Which regions are included in the MIRACLE trial?
Does the filing include clinical results or enrollment numbers?
Where can I find the full press release referenced in the 8-K?
