RenovoRx (RNXT) wins FDA orphan drug designation for oxaliplatin in pancreatic cancer

RenovoRx Inc. (NASDAQ: RNXT) secured orphan drug designation from the U.S. Food and Drug Administration for oxaliplatin as a treatment for pancreatic cancer, the company announced May 28. The designation provides incentives for developing therapies for rare diseases, including seven years of U.S. market exclusivity upon approval, tax credits for clinical trial costs, and exemption from certain FDA user fees. Pancreatic cancer, with a five-year survival rate below 13%, represents a high-unmet-need indication. The orphan status applies to oxaliplatin, a platinum-based chemotherapy agent, and does not directly involve RenovoRx’s lead pipeline candidate, RenovoGem, which uses a proprietary trans-arterial delivery platform. The company said the designation strengthens its broader oncology development program, though it did not disclose specific clinical trial timelines for oxaliplatin in this indication.