Summary by Moomoo AI
RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced on August 26, 2024, that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to its drug opaganib for the treatment of neuroblastoma, a rare childhood cancer. This designation provides seven years of marketing exclusivity upon approval and may offer additional benefits such as faster development and review times, potential grant funding, and tax credits. Neuroblastoma is the most common cancer in infancy and accounts for 15% of pediatric cancer-related deaths in the U.S. The market for neuroblastoma treatments is expected to reach nearly $1.5 billion by the mid-2030s. Opaganib, which is also designated for cholangiocarcinoma, has shown promise in clinical data for various solid tumor cancers and is in development for multiple indications including COVID-19 and Ebola. RedHill Biopharma focuses on gastrointestinal and infectious diseases and promotes drugs such as Talicia for H. pylori infection and Aemcolo for travelers' diarrhea.
