Moleculin Biotech, Inc., a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, announced it has filed a request with the U.S. Food and Drug Administration (“FDA”) for Orphan Drug Status for its drug candidate WP1066.
“Clinical progress with WP1066 has been encouraging,” commented Walter Klemp, Moleculin’s Chairman and CEO. “Given its potential to address rare and difficult to treat cancers, including glioblastoma, we believe WP1066 is well positioned to qualify for Orphan Drug Status.”
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. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
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