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.

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