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Moleculin Biotech highlights interim Phase 3 AML data for annamycin showing 36% CR, 54% CRc in pooled arms

PUBT·09/01/2026 14:37:49
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Moleculin Biotech highlights interim Phase 3 AML data for annamycin showing 36% CR, 54% CRc in pooled arms
  • 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%.
  • 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.
  • Presentation outlined an estimated 2030 NDA approval timeline; cited peak revenue potential of about $807 million for AML.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moleculin Biotech Inc. published the original content used to generate this news brief on September 01, 2026, and is solely responsible for the information contained therein.