Polaryx Therapeutics receives FDA fast track designation for PLX‑200 for late‑infantile neuronal ceroid lipofuscinosis

Polaryx Therapeutics

17 March 2026 - Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage disorders.

Polaryx Therapeutics today announced that the US FDA has granted fast track designation to PLX-200 for the treatment of late-infantile neuronal ceroid lipofuscinosis.

Read Polaryx Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track