On May 28, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that the U.S. Food and Drug Administration (FDA) recently granted RenovoRx Orphan Drug Designation (ODD) of oxaliplatin for the treatment of pancreatic cancer.
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The designation was issued by the FDA’s Office of Orphan Products Development pursuant to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). Oxaliplatin is an approved and commonly used chemotherapy.
As RenovoRx continues to advance its therapeutic pipeline, it is simultaneously expanding commercialization of RenovoCath as a stand-alone device, driving adoption at leading cancer centers and building strategic and clinical collaborations that can support future revenue growth and broader platform use. RenovoCath, a patented FDA-cleared device, employs a dual-balloon infusion catheter for targeted delivery of therapeutic agents directly near a tumor.
This is RenovoRx’s second ODD in pancreatic cancer, and third designation in total, reflecting the Company’s differentiated approach to targeted intra-arterial drug-delivery using RenovoCath. RenovoRx previously received ODD for intra-arterial gemcitabine delivered via RenovoCath (known as IAG) in locally advanced pancreatic cancer (LAPC) and bile duct cancer. This designation for oxaliplatin, a platinum-based chemotherapy widely used in pancreatic cancer treatment, further supports the versatility of RenovoRx’s novel approach to delivering multiple therapeutic agents directly near the tumor site.
ODD carries meaningful regulatory and financial benefits, including:
Seven years of market exclusivity: Upon FDA approval of the designated indication (in this case, intra-arterial oxaliplatin for pancreatic cancer via RenovoCath), RenovoRx would be entitled to seven years of exclusive marketing rights, during which the FDA cannot approve the same drug for the same orphan indication by another sponsor.
Federal tax credit: A 25% tax credit on qualified clinical research expenses incurred in connection with the designated drug.
FDA application fee waiver: A waiver of the FDA application filing fee, which currently exceeds several million dollars for applications requiring clinical data.
Eligibility for orphan product development grants: Access to grant funding from the FDA’s Orphan Products Development grants program to support clinical development.
"Receiving a third ODD from the FDA is an important milestone as it provides additional validation of our strategy to build a multi-agent, targeted, drug-delivery oncology pipeline enabled by our patented RenovoCath device," said Shaun Bagai, Chief Executive Officer of RenovoRx. "Our differentiated technology is designed to deliver therapeutic agents intra-arterially across the arterial wall directly near the tumor site, with potential applications across multiple therapeutic agents and multiple cancer types. The FDA’s ODD of oxaliplatin not only expands our pipeline, but also provides valuable regulatory incentives, including seven years of potential market exclusivity and a waiver of FDA application fees that can total several million dollars. While we are laser focused on finishing our current Phase III clinical trial and advancing commercialization of RenovoCath as a standalone device, we remain committed to advancing our platform and exploring the full potential of targeted oxaliplatin delivery in patients diagnosed with difficult-to-treat cancers."
Pancreatic cancer remains one of the deadliest malignancies, with an estimated 67,530 new cases and more than 52,740 deaths expected in the United States in 2026, according to the American Cancer Society.[1] Despite advances in oncology, the disease is often diagnosed at a late stage in the majority of patients, and the five-year survival rate remains approximately 13%1, underscoring the profound unmet, yet urgent, medical need for new therapeutic approaches.
Oxaliplatin is a key component of FOLFIRINOX, one of the most widely used chemotherapy regimens for patients with advanced pancreatic cancer. RenovoRx is advancing a differentiated approach by delivering oxaliplatin directly near the tumor site using its RenovoCath device.
"This designation for intra-arterial oxaliplatin highlights the breadth of what RenovoCath may offer to pancreatic cancer patients," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "Intra-arterial oxaliplatin may broaden the range of pancreatic cancer targets beyond LAPC that could benefit from localized drug-delivery with RenovoCath."
This ODD for intra-arterial oxaliplatin is separate from and in addition to RenovoRx’s existing ODD for IAG in LAPC and bile duct cancer, which also carries seven years of market exclusivity upon NDA approval by the FDA. RenovoRx’s TIGeR-PaC Phase III clinical trial evaluating IAG in LAPC continues to advance, with the Company anticipating notification of enrollment closure in June 2026 and final data readout in mid to late 2027.
(Press release, Renovorx, MAY 28, 2026, View Source [SID1234666180])