Moleculin gets Georgia RAMPA approval for MIRACLE Phase 2B/3 trial of Annamycin in R/R AML

Moleculin Biotech, Inc.

Regulation Agency for Medical and Pharmaceutical Activities in Georgia approved CTA for AnnAraC (Annamycin + cytarabine) in R/R AML.
Enrollment: 7 subjects treated in Part A (Ukraine); 1 in screening; 16 new EU/US sites expected by end of August.
Part A data readout on first 45 subjects remains on track for 2H 2025; second unblinding expected 1H 2026.
Trial builds to 30+ sites globally; first patient in Georgia expected by end of August.
Annamycin has FDA Fast Track and Orphan Drug Designation, plus EMA Orphan Drug Designation for R/R AML.

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