Polaryx Therapeutics Inc. (NASDAQ:PLYX) shares are up on Tuesday as the company has made significant strides in advancing its clinical programs.
The positive movement follows the announcement that Polaryx has selected a contract research organization for its SOTERIA Phase 2 basket trial, which aims to evaluate its lead candidate, PLX-200, across multiple lysosomal storage disorders.
The SOTERIA trial represents a flexible and resource-efficient mechanism for the clinical development of PLX-200.
Polaryx’s selection of a leading contract research organization marks a pivotal milestone as it prepares to initiate the SOTERIA trial in the first half of 2026. The trial is designed to assess the safety, tolerability, and clinical activity of PLX-200 across four different lysosomal storage disorders, with the company having received a safe to proceed letter from the FDA in October 2025.
The SOTERIA trial will incorporate analyses comparing natural history data as a control arm to the treated arm of PLX-200, which is an orally available compound derived from gemfibrozil. This trial is expected to gather crucial data that will inform the future clinical development pathway for PLX-200, potentially leading to conditional marketing authorization if compelling clinical activity is demonstrated.
PLYX Price Action: Polaryx Therapeutics shares were up 46.06% at $3.52 at the time of publication on Tuesday. The stock is trading near its 52-week low of $2.20, according to Benzinga Pro data.
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