Why Is Blood Cancer Focused Moleculin Biotech Stock Trading More Than 400% On Thursday?

On Thursday, Moleculin Biotech, Inc., MBRX stock is surging with a strong session volume of 64.85 million compared to an average volume of 157.048K, as per data from Benzinga Pro.

The company received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as Ara-C and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for refractory/relapsed Acute Myeloid Leukemia patients.

“While all of the major aspects of the trial remain unchanged, guidance from the FDA recommended an alteration to the statistical plan that will allow us to reduce the size of Part B of our trial by approximately 10%.  Moreover, the nature of the feedback helps us move forward quickly to open sites in the US, in addition to the sites we are expecting to open in Europe and the Middle East. All of this supports the pursuit of an accelerated timeline for new drug approval,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

The MIRACLE Phase 3 study utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized in Part A of the trial to receive high-dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were recommended by the FDA in the company’s end of Phase 1B/2 meeting.

The amended protocol allows for unblinding preliminary primary efficacy data and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects).

This early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC.

The company expects to reach the first unblinding (45 subjects) in the second half of 2025 and the second unblinding, which is expected in the first half of 2026.

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.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory acute myeloid leukemia and soft tissue sarcoma.

Furthermore, Annamycin has an Orphan Drug Designation for relapsed or refractory acute myeloid leukemia from the European Medicines Agency.

Price Action: MBRX stock is up 426% at $2.21 at last check Thursday.

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