Polaryx Says PLX-200 Granted FDA Fast Track Designations for Neurodegenerative Conditions
Polaryx Therapeutics (PLYX) said Tuesday the US Food and Drug Administration granted Fast Track designation to PLX-200 to potentially treat neurodegenerative conditions, including juvenile neuronal ceroid lipofuscinosis, krabbe disease, and sandhoff disease.The designation allows for more frequent interaction with the agency and the possibility of a rolling review for a future marketing application, the company said.Polaryx said PLX-200 now holds Fast Track designation for all four prospective indications that are a part of the SOTERIA phase 2 basket trial. It secured the designation to treat late-infantile neuronal ceroid lipofuscinosis disease in March.Shares of the company were down over 7% in Tuesday's trading.Price: $5.38, Change: $-0.32, Percent Change: -5.65%