GlobeNewswire·May 28, 2026, 8:30 AM ET

RenovoRx Announces FDA Orphan Drug Designation Granted: Oxaliplatin for the Treatment of Pancreatic Cancer

RNXT

RenovoRx, Inc. (NASDAQ: RNXT) announced that the FDA granted Orphan Drug Designation (ODD) for intra-arterial oxaliplatin delivered via the RenovoCath device for the treatment of pancreatic cancer.
This marks the company's second ODD specifically for pancreatic cancer and its third total ODD, following previous designations for intra-arterial gemcitabine (IAG) in locally advanced pancreatic cancer and bile duct cancer.
The ODD provides seven years of market exclusivity upon FDA approval, a 25% federal tax credit on qualified clinical research expenses, a waiver of the FDA application filing fee (which can exceed several million dollars), and eligibility for orphan product development grants.
RenovoRx is simultaneously advancing the commercialization of the RenovoCath device as a stand-alone product, reporting $563,000 in sales for the first quarter of 2026.
The company's Phase III TIGeR-PaC clinical trial evaluating IAG in locally advanced pancreatic cancer anticipates enrollment closure in June 2026, with final data readout expected in mid to late 2027.
CEO Shaun Bagai stated the designation validates the strategy to build a multi-agent, targeted drug-delivery pipeline using the patented RenovoCath platform to treat difficult-to-act cancers.
Chief Clinical Officer Leesa Gentry noted that intra-arterial oxaliplatin may expand the range of pancreatic cancer targets beyond locally advanced disease that could benefit from localized delivery.
Oxaliplatin is a platinum-based chemotherapy widely used in the FOLFIRINOX regimen for advanced pancreatic cancer, which has a five-year survival rate of approximately 13% in the United States.
RenovoRx's TAMP™ therapy platform utilizes the RenovoCath dual-balloon infusion catheter to deliver therapeutic agents directly near the tumor site, aiming to minimize systemic toxicities while improving efficacy.