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May 13, 2026
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
Feb 18, 2026
Moleculin Biotech announced a preliminary blinded composite complete remission rate of 40% in the first 30 subjects of its Phase 2B/3 MIRACLE trial testing Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 17, 2026
Moleculin Biotech announced the Japan Patent Office has issued a notice of allowance for a patent covering proprietary methods for reconstituting liposomal Annamycin, strengthening the company's international intellectual property position.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
