Korea Stem's 'Neuronata-RJ' Receives Non-Designation Response for R-MAT from US FDA

[Asia Economy Reporter Kum Bo-ryeong] Corestem announced on the 11th that the U.S. Food and Drug Administration (FDA) responded with an undesignated result regarding the R-MAT application for the Neuronata-RJ Phase 3 clinical trial.

The target disease is amyotrophic lateral sclerosis (ALS).

Corestem stated, "We applied for R-MAT (Regenerative Medicine Advanced Therapy designation) to the U.S. FDA on September 14 for the Neuronata-RJ Phase 3 clinical trial, and the FDA responded with an undesignated status. R-MAT is a means to receive some convenience during the Phase 3 clinical trial process, and the undesignated status of R-MAT does not affect the progress of the Phase 3 trial itself."