On December 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and highly-aggressive childhood brain cancer (Press release, Kintara Therapeutics, DEC 15, 2022, View Source [SID1234625312]).

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The FDA’s ODD program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people. ODD provides the sponsor of the drug with development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

"This is another important step for us in evaluating VAL-083 as a treatment for brain tumors in addition to our lead indication of glioblastoma," said Robert E. Hoffman, Kintara’s President and CEO. "We will continue with our clinical advancement of the drug candidate with our objective of delivering a much-needed new treatment that can benefit patients."