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Polaryx Therapeutics (Nasdaq: PLYX) will participate in the National Tay-Sachs & Allied Diseases Association Annual Family Conference April 30–May 3, 2026, in Reston, Virginia. Polaryx will engage patients and advocates, share clinical updates on PLX-200 and its Phase 2 SOTERIA basket trial, and discuss its pipeline focused on pediatric lysosomal storage disorders.
Polaryx Therapeutics (Nasdaq: PLYX) announced that the U.S. FDA has granted Fast Track Designation to PLX-200 for CLN3 (JNCL), Krabbe disease, and Sandhoff disease, joining prior FTD for CLN2.
With FTD across all four targeted indications, PLX-200 will be studied in the SOTERIA Phase 2 basket trial, which the company plans to advance into the clinic in the second half of 2026.
Polaryx Therapeutics (Nasdaq: PLYX) was named a Diamond honoree for Excellence in Pediatric Care at the 2026 Pinnacle Awards on April 15, 2026.
The company was recognized for its platform approach to treating rare pediatric lysosomal storage disorders by targeting shared mechanisms such as lysosomal dysfunction and neuroinflammation.
Polaryx Therapeutics (Nasdaq: PLYX) will participate in the 25th Annual Needham Virtual Healthcare Conference, hosting one-on-one investor meetings April 13–16, 2026 and a group presentation on April 16, 2026 at 10:15 a.m. ET.
Live webcasts and archived replays will be available in the Investors Relations "News and Events" section at the company website.
Polaryx Therapeutics (NASDAQ: PLYX) announced that the U.S. FDA granted Fast Track Designation to PLX-200 for Late‑Infantile Neuronal Ceroid Lipofuscinosis (CLN2) on March 17, 2026. The designation may enable more frequent FDA interactions and potential rolling review for a future marketing application.
Polaryx said this regulatory milestone supports initiation of the SOTERIA Phase 2 open-label basket trial evaluating PLX-200 across CLN2, CLN3, Krabbe disease, and Sandhoff disease.
Polaryx Therapeutics (Nasdaq: PLYX) is deepening engagement with the Krabbe disease community through two March 2026 events and by advancing its SOTERIA phase 2 trial of PLX-200.
Executives will attend the KTRN meeting (March 18–20, 2026) and Putt-Putt to #CureKrabbe (March 20, 2026), and the SOTERIA trial will evaluate PLX-200 across CLN2, CLN3, Krabbe, and Sandhoff disease.
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.