Moleculin Biotech (NASDAQ: MBRX) shares are 31% higher mid-morning after the company said it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Annamycin for the treatment of acute myeloid leukemia (AML). This designation will provide the company several benefits, such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. “We are pleased to report this key milestone and the FDA’s decision to grant Annamycin orphan drug designation. We look forward to announcing additional milestones in regard to our clinical pathway as we make further progress,” Moleculin chairman and CEO Walter Klemp stated in the news release.
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About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. The company’s lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. Moleculin also has two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors. For more information about Moleculin, please visit www.moleculin.com.
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