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RedHill Biopharma Ltd. announced that the FDA has granted rare pediatric disease designation to its investigational…
RDHLRedHill Biopharma Ltd.
RedHill Biopharma Ltd. announced that the FDA has granted rare pediatric disease designation to its investigational drug opaganib for the treatment of neuroblastoma. This designation provides potential benefits such as a Priority Review Voucher, accelerated development and review times, tax credits, and seven-year marketing exclusivity upon approval. The neuroblastoma market is estimated to be valued at $3.5 billion by 2032. RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal, infectious, and oncology-related indications.