RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug Designation
RedHill Biopharma (RDHL) announced that the FDA granted rare pediatric disease designation to its investigational drug opaganib for the treatment of neuroblastoma. This designation, added to existing orphan drug status, provides potential benefits including a Priority Review Voucher, accelerated review times, and seven years of marketing exclusivity if approved. Cumberland Pharmaceuticals (CPIX) is the U.S.
Key figures
- Drug Name
- opaganib
- Us diagnoses per year
- ~750
- High risk survival rate
- ~50%
- Global pediatric cases per year
- ~5,500
- Neuroblastoma market value 2032
- $3.5 billion
AI analysis
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