Polaryx Shares Rise As FDA Grants Fast-track Status Across All SOTERIA Trial Indications

(RTTNews) - Shares of Polaryx Therapeutics, Inc. (PLYX) were up 10% after the company announced that the U.S. FDA has granted Fast Track Designation for all four indications to be evaluated in its upcoming SOTERIA Phase 2 basket trial. With this decision Polaryx now holds Fast Track status for PLX-200 in Late-Infantile Neuronal Ceroid Lipofuscinosis (CLN2), Juvenile Neuronal Ceroid Lipofuscinosis (CLN3), Krabbe disease, and Sandhoff disease- all rare, progressive lysosomal storage disorders that currently have limited or no disease-modifying treatment options. CLN2 and CLN3 are progressive childhood neurodegenerative disorders that impair movement, vision, and cognitive development, while Krabbe disease and Sandhoff disease are lysosomal storage disorders that cause rapid buildup of harmful cellular waste. PLX-200, Polaryx's lead candidate, is an orally available formulation of Gemfibrozil, a long-established lipid-regulating therapy that has shown the ability to cross the blood-brain barrier in preclinical studies. The company believes this property, combined with decades of known safety data in adults, may help accelerate clinical development timelines. The SOTERIA trial is designed as an open-label, single-arm Phase 2 study that will evaluate safety, tolerability, and clinical activity across the four indications. Polaryx plans to initiate the trial in the second half of 2026 in the U.S., Europe, and Asia. For the CLN2 and CLN3 cohorts, the study will incorporate comparisons to natural history data to contextualize treatment effects. "We are delighted by the FDA's decision to further extend Fast Track Designation to CLN3, Krabbe disease, and Sandhoff disease," said Alex Yang, Chair and Chief Executive Officer of Polaryx Therapeutics. PLYX has thus far hit a low of $2.20 and a high of $48.91. The stock closed Monday's trading at $5.70, down 6.86%. In pre-market trading the stock is at $6.25, up 10%. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.