Kintara Therapeutics, Inc. (NASDAQ: KTRA) is engaged as a biopharmaceutical company, which is focused on the research and development of innovative therapies targeting solid tumor cancers. The San Diego-based biopharma company has two late-stage, Phase 3-ready drug programs: VAL-083 for glioblastoma and REM-001 for cutaneous metastatic breast cancer (CMBC).
Shares of the oncology company are rallying 23% through afternoon trading on Thursday, December 15, 2022. Over the past three months, Kintara Therapeutics has seen average daily volume of 379,840 shares. However, volume of 393,415 shares or dollar volume of around $3.86 million, has already exchanged hands through afternoon trading.
Shares of Kintara Therapeutics are gaining after the company announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and very aggressive childhood brain cancer.
VAL-083 is a first-in-class, small-molecule chemotherapeutic with a novel action mechanism that has demonstrated the ability to generate clinical activities in a range of cancers.
Orphan Drug Designation is a major achievement for the company, as it provides several incentives for the company, such as tax credits, development incentives, prescription drug user fee exemptions and a seven-year marketing exclusivity period upon FDA approval. The Orphan Drug program elevates drugs and innovative treatments that are meant to treat, diagnose, or prevent a rare disease that affects fewer than 200,000 people.
“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.”
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