Polaryx Therapeutics Says FDA Grants Fast Track Designation To PLX-200 For Treatment Of JNCL/CLN3 Disease, Krabbe Disease, And Sandhoff Disease

Polaryx Therapeutics, Inc. (NASDAQ:PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, 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.

The Fast Track program is designed to facilitate and expedite the review of therapies intended to treat serious or life-threatening conditions with unmet medical need. Companies receiving Fast Track Designation may benefit from more frequent interactions with the FDA and the potential for rolling review of a future marketing application.