Moleculin Biotech highlights interim Phase 3 AML data for annamycin showing 36% CR, 54% CRc in pooled arms
MBRX•Commercial outlook
Presentation outlined an estimated 2030 NDA approval timeline; cited peak revenue potential of about $807 million for AML.
Cardiac safety and trial progress
Cardiac-safety review across 90 patients reported zero cardiotoxicity; mean change in LVEF was -0.12% with cumulative exposure up to 2,970 mg/m².
Part A enrollment stood at 75 of 90 patients; full recruitment targeted in 3Q 2026, with an unblinded n=90 readout in 4Q 2026 or 1Q 2027.
Interim Phase 3 MIRACLE data on annamycin
Moleculin Biotech investor presentation highlighted Annamycin as a potentially non-cardiotoxic anthracycline in an FDA-guided pivotal Phase 3 MIRACLE trial.
First interim MIRACLE data (n=45) showed pooled Annamycin arms CR 39% and CRc 54% versus control CR 12% and CRc 29%.
