Navidea tumbles on extended US FDA review for radioactive tracing agent
This article was originally published in Clinica
Executive Summary
Shares of Navidea Biopharmaceuticals, formerly known as Neoprobe, tumbled as low as 39 cents, down 12%, on 3 April, after the Dublin, Ohio-based firm said the US FDA extended by three months the Prescription Drug User Fee Act (PDUFA) action date for the new drug application (NDA) for the company's radioactive diagnostic tracing agent Lymphoseek (tilmanocept). The radiotracer is designed for use in intraoperative lymphatic mapping (ILM), a surgical oncology procedure used primarily in patients with breast cancer and melanoma to determine if disease has spread to the lymph nodes.