Alume Biosciences Granted FDA Fast Track Designation Of ALM-488 For Surgical Nerve Visualization
Fast Track Designation Highlights the Urgent Need for Improved Intraoperative Nerve Identification
[La Jolla, CA] — [May 12, 2021] – Alume Biosciences, Inc., a clinical stage biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound ALM-488. ALM-488 is an investigational fluorescently labelled nerve targeting pharmaceutical being developed as an adjunct for the visualization of nerves at risk for injury during head and neck surgery. The Fast Track designation was approved by the FDA Division of Medical Imaging and Radiation Medicine (DMIRM), which is responsible for drug products used in the image-based diagnosis and monitoring of diseases.