Moleculin Biotech reports 60% of first 45 subjects in ‘MIRCALE’ Phase 3 trial

Moleculin Biotech (MBRX) provided an enrollment update with 60% of the target number of subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 “MIRACLE” study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia who are refractory to or relapsed (R/R) after induction therapy. The targeted number for the first unblinding of data is 45 subjects. Additional subjects continued to be identified by site investigators. This update is as of November 4, 2025, as identification and recruitment are ongoing. The Company expects to complete treatment of the first 45 subjects in the first quarter of 2026 with the initial unblinding of data thereafter.