Moleculin Receives Positive FDA Guidance for Acceleration of its Registration-Enabling MIRACLE Trial for R/R Acute Myeloid Leukemia (AML)
Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 HOUSTON, Feb. 13, 2025 -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage...
Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial
First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025...
Moleculin Participates in Virtual Investor “What This Means” Segment
- Walter Klemp, CEO of Moleculin, provides an update on the Company's Phase 3 pivotal trial of Annamycin for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial) - Watch the "What This Means" segment...
Moleculin Highlights Development Progress of Annamycin, Phase 2 Data Outperforms Billion-Dollar Assets in AML, Phase 3 Data Readouts in 2025 & 2026
- Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged leading contract research organization (CRO); On track to begin dosing of Annamycin in combination with cytarabine for the treatment...
Moleculin Announces Online Publication of Preclinical Data Demonstrating Significant Activity of Annamycin in Venetoclax Resistant AML Model
Abstract published as part of the American Society of Hematology (ASH) Annual Meeting Study shows Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant acute myeloid leukemia (AML) cell lines from heavily pretreated relapsed/refractory primary...
New Findings Show Moleculin’s Annamycin Overcomes Resistance to Venetoclax in AML
Preclinical data accepted for online publication at ASH Annual Meeting reveal significant activity of Annamycin in Venetoclax resistant AML model New preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or...
Moleculin Accelerates Planned Unblinded Data Readout for MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial to H2 2025
Amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the...
Moleculin Receives Institutional Review Board Approval for MIRACLE Phase 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R Acute Myeloid Leukemia (AML)
Company on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Trial designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or...
Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update
- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 - Median durability of CRc in MB-106 Annamycin+...
Moleculin to Report Third Quarter 2024 Financial Results on November 8, 2024 and Host Conference Call and Webcast
HOUSTON, Nov. 5, 2024 -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial...