Posted by Michael Wonder on 23 Apr 2026
Polaryx Therapeutics receives US FDA fast track designations for all four indications to be evaluated in the SOTERIA basket trial
21 April 2026 - Polaryx Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3 disease), Krabbe disease (globoid cell leukodystrophy), and Sandhoff disease (GM2 gangliosidosis Type II).
Following the March 2026 grant of FTD to PLX-200 in treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease), PLX-200 now holds FTD for all four prospective indications to be studied in the SOTERIA Phase 2 basket trial.
