Core Insights - Moleculin Biotech, Inc. (MBRX) stock has experienced a significant surge, increasing by 426% to $2.21 with a trading volume of 64.85 million shares compared to an average of 157.048K shares [1][7]. Company Developments - The company received FDA feedback on its IND amendment, allowing a reduction in the size of its Phase 3 pivotal trial for Annamycin in combination with Cytarabine for refractory/relapsed Acute Myeloid Leukemia patients [2][3]. - The FDA's guidance recommended an alteration to the statistical plan, enabling a 10% reduction in the size of Part B of the trial, facilitating quicker site openings in the US, Europe, and the Middle East [3]. - The MIRACLE Phase 3 study employs an adaptive design, with the first 75 to 90 subjects randomized to receive high-dose cytarabine combined with either placebo or two different doses of Annamycin [4]. - The amended protocol allows for early unblinding of preliminary primary efficacy data and safety/tolerability results at 45 subjects, with expectations for the first unblinding in the second half of 2025 and the second in the first half of 2026 [5]. Trial Details - For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin [6]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory acute myeloid leukemia and soft tissue sarcoma, as well as Orphan Drug Designation from the European Medicines Agency for the same conditions [6].
Why Is Blood Cancer Focused Moleculin Biotech Stock Trading More Than 400% On Thursday?