MBRX - Moleculin Bio's Annamycin an Orphan Drug in U.S. for soft tissue sarcomas

The FDA has granted an Orphan Drug Designation ((ODD)) to Moleculin Biotech's (MBRX) Annamycin for treatment of soft tissue sarcomas. Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.Also, the Agency has recently signed off Moleculin's IND for Annamycin to launch a Phase 1B/2 trial in U.S. for patients with soft tissue sarcoma."This is now the second Orphan Drug designation for Annamycin, as Annamycin previously received ODD for the treatment of relapsed or refractory acute myeloid leukemia," commented Walter Klemp, Chairman and CEO.MBRX shares up 7% premarket

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Moleculin Bio's Annamycin an Orphan Drug in U.S. for soft tissue sarcomas