Polaryx rises after FDA grants fast-track status for rare disease drug

Polaryx Therapeutics

21/04/2026 14:11

** Shares of drug developer Polaryx Therapeutics PLYX.O rise 4.76% to $5.97 premarket

** Company says the U.S. FDA has granted fast-track status to its experimental drug, PLX-200, for CLN3 disease, Krabbe disease and Sandhoff disease — three rare genetic disorders that damage the nervous system

** FDA's fast-track tag is meant to speed up development and review of treatments for serious diseases with unmet medical needs

** With the fast-track grant it received in March for CLN2 disease, PLX-200 now has the designation for all four disorders planned for its next study - PLYX

** Company plans to start a mid-stage study in the second half of 2026, testing PLX-200 across all four disorders in the United States, Europe and Asia

** PLYX shares down 83.7% since their IPO in February

 (Reporting by Kunal Das in Bengaluru)

 ((Kunal.Das2@thomsonreuters.com;))