Pivotal MIRACLE Trial Interim Data Unblinding On Track for Mid-2026, Showing 40% Preliminary CRc Rate
MBRX sits 16% above its 52-week low of $1.79 on light trading volume (0.3× avg).
Summary
Moleculin Biotech reported its full-year 2025 financial results and confirmed that the highly anticipated 45-patient interim data unblinding in its pivotal MIRACLE trial for relapsed or refractory Acute Myeloid Leukemia (R/R AML) is on track for mid-2026. The company highlighted encouraging preliminary blinded efficacy data, including a 40% composite complete remission (CRc) rate in the first 30 treated subjects, which significantly outperforms historical outcomes. This news follows the company's 10-K filing yesterday, which included a going concern warning and noted a short cash runway into Q3 2026, and an 8-K filed concurrently reporting the financial results and general clinical updates. For a small-cap biotech facing significant financial challenges, the confirmed timeline for a pivotal trial's interim data unblinding, coupled with promising preliminary efficacy data, is a critical forward-looking catalyst. Traders will closely monitor the mid-2026 unblinding, as this will be a defining moment for the MIRACLE trial and the company's future prospects.
At the time of this announcement, MBRX was trading at $2.08 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $10.3M. The 52-week trading range was $1.79 to $33.00. This news item was assessed with neutral market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.