synopsis

The trial, which will involve sites in the U.S., Europe, and the Middle East, aims to combine Phase 2B and Phase 3 data for efficacy evaluation of the Miracle trial of Annamycin for relapsed or refractory acute myeloid leukemia.

Retail chatter around Moleculin Biotech surged on Monday after the company said the European Medicines Agency had approved its Clinical Trial Application for a pivotal Phase 2B/3 study of Annamycin in combination with cytarabine for patients with relapsed or refractory acute myeloid leukemia.

The European Medicines Agency approved the randomized, placebo-controlled trial in all nine European Union countries where Moleculin Biotech filed it. 

It will include research locations in the U.S. and the Middle East. 

Moleculin Biotech shares closed 2.86% higher at $1.08 on Monday, before slipping 3.7% to $1.04 in after-hours trading.

Researchers will combine the Phase 2B study with Phase 3 testing to measure primary efficacy according to international regulatory requirements.

Part A of the trial will recruit between 75 and 90 patients randomly assigned to receive HiDAC with a placebo or one of two FDA-approved Annamycin doses of 190 mg/m² or 230 mg/m². 

The initial patient data set from 45 participants will become available during the second semester of 2025, and researchers anticipate the second unblinding to occur at the beginning of 2026. 

The trial will expand to include approximately 220 patients during Phase 3 enrollment (Part B).

EMA approval depends on Moleculin providing nonclinical GLP data before starting Part B, necessitating protocol modifications afterward. 

The trial uses an adaptive design that supports the FDA’s Project Optimus goal of improved oncology dose selection.

The company remains on course to deliver its expected interim readout this year, as patient dosing has already started.

On Stocktwits, retail sentiment was ‘bullish’ amid a 3,700% surge in 24-hour message volume.

Some traders expressed appreciation for the stock’s steady performance, with one noting that market makers were doing a good job “keeping it tight” for those accumulating shares of Moleculin.

Another described the 2.86% rise of the stock as “decent” and said “low and slow will win the race.”

The stock has declined nearly 39% so far in 2025.

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