Polaryx Therapeutics Says FDA Grants Fast Track Designation To PLX-200 For Treatment Of Late-Infantile Neuronal Ceroid Lipofuscinosis

Polaryx Therapeutics, Inc. (NASDAQ: PLYX) announced that the FDA has granted Fast Track Designation to its drug PLX-200 for treating Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease). This designation supports the advancement of the SOTERIA Phase 2 basket trial, which evaluates PLX-200 across multiple lysosomal storage disorders. Fast Track status may allow for more frequent interactions with the FDA and the possibility of a rolling review for future marketing applications.