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Polaryx Therapeutics Says FDA Grants Fast Track Status to PLX-200
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Polaryx Therapeutics Says FDA Grants Fast Track Status to PLX-200
Mar 17, 2026 7:08 AM

09:48 AM EDT, 03/17/2026 (MT Newswires) -- Polaryx Therapeutics ( PLYX ) said Tuesday the US Food and Drug Administration has granted Fast Track designation to PLX-200, a potential treatment for late-infantile neuronal ceroid lipofuscinosis (CLN2) 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 is currently being evaluated in a phase 2 study across four rare lysosomal storage disorders: CLN2, CLN3, Krabbe disease, and Sandhoff disease.

Shares of the company were down 2.4% in Tuesday trading.

Price: 5.81, Change: +0.13, Percent Change: +2.29

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