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Moleculin Stock Rises After FDA Grants Annamycin Orphan Drug Designation For Soft Tissue Sarcomas

Moleculin Biotech, Inc., (MBRX), a clinical stage pharmaceutical company, said Tuesday that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. The company's shares are rising more than 8 percent in pre-market activity.

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.

"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," said Walter Klemp, Chairman and CEO of Moleculin.

Moleculin recently said that the FDA accepted its request for Investigational New Drug or IND status for Annamycin, allowing the company to commence a Phase 1B/2 clinical trial in the U.S. for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease.

The rationale for this clinical trial includes recent animal data, including data presented at the American Association of Cancer Research (AACR) Annual Meeting held from June 22 to 24, 2020.

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