- In August 2024, RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for the treatment of neuroblastoma, a childhood cancer that originates from immature nerve cells and is responsible for 15% of pediatric cancer-related deaths. This designation will help the company by providing regulatory benefits such as market exclusivity, tax incentives, and reduced development costs, accelerating the potential for opaganib to reach the market and offer new treatment options for pediatric neuroblastoma patients.
- In August 2024, the FDA has granted both rare pediatric disease designation and orphan drug designation to INV724 for treating neuroblastoma patients. These designations will benefit the company by providing regulatory advantages such as market exclusivity, financial incentives, and expedited development processes, helping accelerate the treatment's path to market.
- In February 2024, NBUK and SKCUK, two of the U.K.'s largest funders of neuroblastoma research, have formed a new partnership with a clear plan to work more closely and regularly together to improve outcomes for children with the condition of neuroblastoma. This collaboration will help the company by increasing research funding, fostering innovation, and accelerating the development of effective treatments.
