Moleculin Biotech Nears First Unblinding Milestone in Pivotal Phase 3 AML Trial

Reuters
2025.11.13 13:36
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Moleculin Biotech Inc. is nearing the first unblinding milestone in its pivotal Phase 3 AML trial. As of November 4, 2025, 60% of the targeted 45 subjects have consented to participate. The company expects to complete treatment of these patients in Q1 2026, with initial unblinded data to follow. The trial spans five countries, with further unblinding anticipated in the first half of 2026.

Moleculin Biotech Inc. has announced an update on the enrollment progress of its pivotal Phase 2B/3 “MIRACLE” clinical trial evaluating Annamycin in combination with cytarabine for adult patients with relapsed or refractory acute myeloid leukemia (AML). As of November 4, 2025, 60% of the targeted 45 subjects for the first planned interim unblinding have consented to participate. The company anticipates completing treatment of these initial 45 patients in the first quarter of 2026, with initial unblinded data expected to be released thereafter. Additional subjects continue to be identified, and the second unblinding is anticipated in the first half of 2026. The trial is being conducted across sites in five countries. Results from this study have not yet been presented. 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 via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001437749-25-034635), on November 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here