Israel-based specialty biopharmaceutical company RedHill Biopharma Ltd. (Nasdaq: RDHL) announced on Monday that it has received orphan-drug designation from the US Food and Drug Administration (FDA) for Opaganib intended for the treatment of neuroblastoma.

Orphan Drug designation provides a seven-year marketing exclusivity period if Opaganib is approved in neuroblastoma, and can confer additional benefits, like accelerated development and review times, potential grant funding and possible tax credits.

Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection.

Dr Mark Levitt, RedHill chief scientific officer, said, 'RedHill is proud to have received a second orphan-drug designation for opaganib in oncology, following its previous designation for cholangiocarcinoma (CCA, also known as bile duct cancer). This designation for neuroblastoma – the most common infancy malignancy and for which new options are urgently needed – adds to opaganib's potential as a novel oncological agent. Opaganib has broad oncology potential with promising preliminary clinical data in solid tumour cancers such as prostate cancer and CCA, and data from a range of U.S. government supported and Apogee conducted preclinical studies in various indications, including radioprotection, and also in combination with RedHill's RHB-107. We also see such utility extending to the potential for opaganib to have a sensitising effect in hormone receptor pathway inhibition therapy, which the Company expects to test in a planned externally funded Phase 2 study.'