10:29 AM EDT, 04/21/2026 (MT Newswires) -- 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