USFDAMay 28, 2026, 08:32 AM
RenovoRx Gets FDA Orphan Drug Designation for Oxaliplatin in Pancreatic Cancer
AI Summary
RenovoRx, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for oxaliplatin for the treatment of pancreatic cancer. This is the company's second ODD in pancreatic cancer and third overall, underscoring its targeted intra-arterial drug-delivery approach using the RenovoCath device. The ODD provides significant regulatory and financial benefits, including seven years of market exclusivity upon FDA approval, a 25% federal tax credit on clinical research expenses, and a waiver of FDA application fees. RenovoRx continues to advance its therapeutic pipeline, including the Phase III TIGeR-PaC trial, and expand commercialization of RenovoCath.
Key Highlights
- FDA granted Orphan Drug Designation for oxaliplatin for the treatment of pancreatic cancer.
- This marks RenovoRx's second ODD in pancreatic cancer and third overall.
- The ODD provides seven years of market exclusivity upon FDA approval of the designated indication.
- It also includes a 25% federal tax credit on qualified clinical research expenses.
- The designation waives FDA application filing fees, which can total several million dollars.
- RenovoRx anticipates enrollment closure for its TIGeR-PaC Phase III trial in June 2026.
- Final data readout for the TIGeR-PaC trial is expected in mid to late 2027.
- Pancreatic cancer is projected to have 67,530 new cases and over 52,740 deaths in the US in 2026.
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