UPDATE: Moleculin Biotech (MBRX) Announces $6M Registered Direct Offering at $0.80/Unit
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Moleculin Biotech (MBRX) to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial
February 5, 2020 7:34 AM ESTMoleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it intends to discuss with the FDA and EMA (European Medicines Agency) plans to conduct a single arm Phase 2 trial that would serve as the basis for accelerated approval of Liposomal Annamycin ("Annamycin") to treat relapsed or refractory acute myeloid leukemia ("AML"). This will follow the establishment of a recommended Phase 2 dose ("RP2D") in the Company's ongoing Phase 1 dose escalation trial in Europe. The FDA has... More
