• Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage disorders

     

PARAMUS, NJ, March 17, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (NASDAQ:PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric lysosomal storage disorders ("LSDs"), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease).

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.