Polaryx Therapeutics, Inc. (PLYX) said Tuesday that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate PLX-200 for the treatment of late-infantile neuronal ceroid lipofuscinosis. Shares of Polaryx were more than 7% up in pre-market trading.
According to National Institutes of Health, neuronal ceroid lipofuscinosis (NCL) are a group of genetically mediated neurodegenerative disorders affecting children and young adults.
"Receiving fast track designation represents an important regulatory milestone as we prepare to initiate the SOTERIA Phase 2 basket trial evaluating PLX200 across multiple lysosomal storage disorders," said Alex Yang, Chair and Chief Executive Officer of Polaryx Therapeutics.
Polaryx stock had closed at $5.68 on Monday, down 10.69%.
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