Polaryx Therapeutics (Nasdaq: PLYX) marked Rare Disease Day and reaffirmed its commitment to patients with rare pediatric lysosomal storage disorders by advancing the SOTERIA Phase 2 trial of lead candidate PLX-200.
The open-label, single-arm SOTERIA study will evaluate safety, tolerability, and clinical activity across four LSDs: CLN2, CLN3, Krabbe, and Sandhoff disease.
Polaryx Therapeutics (Nasdaq: PLYX) selected a contract research organization to run SOTERIA, a Phase 2, open-label, single-arm basket trial of lead candidate PLX-200 across four lysosomal storage disorders. The company received an FDA safe to proceed letter in October 2025 and aims to initiate the trial in the first half of 2026.
The CRO brings experience in rare pediatric LSD trials and relationships with key opinion leaders and patient advocacy groups to support enrollment and trial operations.
Polaryx (Nasdaq: PLYX) presented preclinical PLX-200 (reformulated gemfibrozil) data for Krabbe disease at WORLDSymposium on February 6, 2026. Findings in GALC-/- mice showed reduced astrogliosis and psychosine, myelin protection, restored motor function and increased lifespan. Polaryx received an FDA safe-to-proceed letter in October 2025 and plans to start the Phase 2 SOTERIA basket trial in H1 2026 to evaluate PLX-200 across multiple lysosomal storage disorders.
Polaryx Therapeutics (Nasdaq: PLYX) announced three new board appointments effective January 29, 2026: Mitchel Berger, M.D., Francis A. Braun III, CPA, and Charles Ryan, J.D., Ph.D., while Andrew O ceased board service on the same date.
The company highlighted these additions as strengthening governance and expertise as its lead candidate, PLX-200, advances into an IND-approved SOTERIA Phase 2 basket trial and as Polaryx continues as a newly listed Nasdaq public company.
Polaryx (NASDAQ: PLYX) will present late-breaking preclinical data on PLX-200 for Krabbe disease at the 22nd Annual WORLDSymposium™ (Feb 2-6, 2026).
Data support advancing the Phase 2 SOTERIA basket trial (CLN2, CLN3, Krabbe, Sandhoff). The company received an FDA safe to proceed letter in October 2025 and plans trial initiation in the first half of 2026. Presentation: Feb 6, 2026, 9:00am PST; presenter Shrijay Vijayan, Ph.D., MBA.
Polaryx Therapeutics (NASDAQ: PLYX) announced a direct listing on the Nasdaq Capital Market effective February 2, 2026, with shares trading under the ticker PLYX. The company is a clinical-stage biotech focused on novel therapies for rare pediatric lysosomal storage disorders.
Polaryx highlighted a planned launch in H1 2026 of SOTERIA, a single-arm, open-label Phase 2 basket trial evaluating lead candidate PLX-200 for multiple LSD indications. Maxim Group served as exclusive financial advisor; Gibson Dunn and Brownstein Hyatt Farber Schreck served as legal and Nevada counsel, respectively.
Polaryx Therapeutics (Nasdaq:PLYX) announced that its common stock has been approved for listing on the Nasdaq Capital Market under the ticker PLYX, with trading expected to begin on or about February 2, 2026. The company plans a direct listing and will launch a new Investor Relations website.
Polaryx said it is preparing to initiate SOTERIA, a single-arm, open-label Phase 2 basket trial of lead candidate PLX-200 assessing safety, tolerability, and clinical activity across multiple lysosomal storage disorder indications.