Polaryx Receives FDA Fast Track Designation for PLX-200
Polaryx announced that the FDA has granted Fast Track Designation to PLX-200 for the treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis, or 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.
