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Get filing alertsMoleculin nearing pivotal AML trial data readout, unblinding expected before June 30
Filed May 13, 2026 · Period ending May 13, 2026 · ~1 min read
Key Changes
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First data unblinding from Phase 2B/3 MIRACLE trial testing Annamycin for relapsed/refractory acute myeloid leukemia expected before June 30, 2026, reaffirming prior timeline.
Item 7.01 verify on EDGAR → -
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Trial compares two dose levels of Annamycin plus cytarabine against placebo plus cytarabine in patients who failed initial AML treatment.
Press Release verify on EDGAR →
Summary
Moleculin Biotech announced it is approaching a critical milestone: the first unblinding of data from its pivotal Phase 2B/3 MIRACLE trial. This trial evaluates Annamycin, the company's lead drug candidate, combined with cytarabine for treating acute myeloid leukemia patients who have relapsed or not responded to initial therapy.
The study tests two different Annamycin doses against a control arm, and results are expected before the end of June 2026. For retail investors, this is a binary event that will likely drive significant stock movement. Positive data could validate Annamycin's efficacy and advance the drug toward potential FDA approval in a serious cancer indication. Negative or inconclusive results could derail the program.
The company is reaffirming its previously communicated timeline, suggesting the trial remains on track. Investors should watch for the actual data release in the coming weeks and pay attention to key metrics like response rates and safety profiles compared to the control arm.
Section-by-Section Diff
Event · Item 9.01 — Financial Statements and Exhibits
Moleculin Biotech filed an 8-K attaching a press release dated May 13, 2026; no material business event disclosed in the filing body.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
99.1 Press Releasedated May 13, 2026
The company attached a press release dated May 13, 2026 as Exhibit 99.1. The 8-K body does not describe the content of the press release, so the nature of the disclosure cannot be determined from this filing alone.
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Figures/quotes linked to EDGAR · Narrative written by AI · May 27, 2026 · How we verify