HEPA - VBI Vaccines Hepion win FDA Orphan Drug Designations for cancer candidates

VBI Vaccines (NASDAQ:VBIV) and Hepion Pharmaceuticals (HEPA) are trading sharply higher on Friday after the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designations for two of thier cancer candidates. According to a federal register, the FDA has granted the designation for a bivalent cytomeglaovirus gB/pp65 enveloped virus-like particles designed by VBI Vaccines (VBIV) for the treatment of glioblastoma. Hepion (HEPA) has earned the designation for rencofilstat as a treatment for hepatocellular carcinoma. With its orphan drug designation, the FDA aims to offer financial incentives to drug developers targeting rare diseases and conditions. In addition to tax credits for clinical trial costs and waiver of the user fee for marketing applications, the developers of orphan drugs can claim seven years of marketing exclusivity upon regulatory approval of the treatment.

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VBI Vaccines, Hepion win FDA Orphan Drug Designations for cancer candidates