Moleculin Biotech advances Annamycin for R/R AML treatment, with Phase 3 MIRACLE trial set to begin in Q1 2025. Preliminary results show 60% CR/CRi in Venetoclax-refractory patients. Accelerated data readouts expected in 2H 2025 and 1H 2026, with potential NDA by 2027. Annamycin shows promise as a safer, more effective treatment option.
Moleculin Biotech advances Annamycin in Phase 3 MIRACLE trial for R/R AML, aiming for Q1 2025 dosing. Achieved 60% CR/CRi in Venetoclax-refractory cases, surpassing historical rates. Accelerated data readouts expected by 2H 2025 (n=45) and 1H 2026 (n=75-90), with potential NDA by 2027. Annamycin shows promise as a safer, more effective AML treatment.
Moleculin Biotech advances Annamycin for R/R AML treatment, with Phase 3 MIRACLE trial set to begin dosing in Q1 2025. Preliminary results show 60% CR/CRi in Venetoclax-refractory patients, outperforming historical rates. Accelerated timelines aim for NDA by 2027, highlighting Annamycin's potential as a safer, more effective AML treatment.
Moleculin Biotech received IRB approval for the MIRACLE Phase 3 trial, aiming to treat R/R AML with Annamycin and cytarabine by Q1 2025. Accelerated timelines suggest recruitment updates by 2H 2025 and preliminary readouts by 1H 2026, with potential NDA by 2027. Annamycin showed 60% CR/CRi in Venetoclax-refractory patients, outperforming historical rates, indicating its potential as a game-changing AML treatment.
Moleculin Biotech announced Annamycin's efficacy against Venetoclax-resistant AML, with preclinical data published online. The company also updated its Phase 3 trial timeline to H2 2025, received IRB approval for the MIRACLE trial, and reported Q3 2024 financials. Additionally, Moleculin highlighted Annamycin's potential in AML treatment and its participation in investor conferences.
Annamycin, a non-cardiotoxic anthracycline, shows efficacy against Cytarabine and Venetoclax-resistant AML, with a 60% CRc rate in relapsed/refractory patients. It exhibits synergy with Ara-C, lacks cardiotoxicity, and may induce immune memory, suggesting potential as a treatment option for high-risk AML patients.
Annamycin shows promise in treating Ara-C and Venetoclax resistant AML, with no cardiotoxicity and synergy with Ara-C. Preclinical and preliminary clinical data indicate a 60% CRc rate in relapsed/refractory AML patients. Moleculin Biotech is advancing Annamycin in a Phase 3 trial for R/R AML, with Fast Track and Orphan Drug Designations.
Moleculin Biotech announced Annamycin's effectiveness against resistant AML cell lines, showing no cardiotoxicity and potential immune benefits. A Phase 3 trial for AnnAraC in AML treatment is set for 2025. The study was presented at the American Society of Hematology meeting, with Moleculin's stock rising 13.26% to $2.72.