Polaryx Therapeutics Selects Contract Research Organization for SOTERIA Phase 2 Basket Trial
Rhea-AI Summary
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.
Positive
- FDA safe to proceed letter received in October 2025
- Selected experienced CRO to manage SOTERIA operations
- Phase 2 trial spans four lysosomal storage disorders
- Target initiation in first half of 2026
Negative
- SOTERIA is an open-label, single-arm trial limiting controlled efficacy comparison
- No disclosed financing or enrollment timelines beyond H1 2026
News Market Reaction
On the day this news was published, PLYX gained 64.32%, reflecting a significant positive market reaction. Argus tracked a peak move of +1891.8% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $45M to the company's valuation, bringing the market cap to $114M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 10 | Clinical data update | Positive | -24.1% | Preclinical PLX-200 data for Krabbe disease presented with positive mouse outcomes. |
Recent clinically focused announcements around SOTERIA and PLX-200 have coincided with sharp price declines despite development progress.
Over recent weeks, Polaryx has highlighted progress for PLX-200 and the SOTERIA program. On Feb 3, 2026, it flagged late-breaking preclinical data and plans to start the Phase 2 basket trial in H1 2026, with a -37.29% move. On Feb 10, 2026, additional preclinical data were presented, followed by a -24.11% reaction. Today’s CRO selection further advances SOTERIA toward initiation in the first half of 2026, continuing this clinical-development theme.
Historical Comparison
Past clinical-trial news for PLYX saw a -24.11% move. Today’s -17.47% reaction to another SOTERIA milestone is similarly negative in direction and scale.
Clinical-trial news has evolved from preclinical PLX-200 data and an FDA safe-to-proceed letter toward operational readiness, including CRO selection and planned SOTERIA Phase 2 initiation in H1 2026.
Market Pulse Summary
The stock surged +64.3% in the session following this news. A strong positive reaction aligns with Polaryx’s ongoing advancement of the SOTERIA program, now marked by CRO selection for the Phase 2 basket trial of PLX-200. Historically, clinical-trial news (such as the Feb 10, 2026 update with a -24.11% move) drew selling pressure, so a large gain would have contrasted that pattern. Investors would still need to weigh concentration of ownership and the stock’s proximity to its $2.201 52-week low.
Key Terms
lysosomal storage disorders medical
contract research organization technical
CRO technical
open-label medical
single-arm medical
basket trial medical
key opinion leaders medical
FDA regulatory
AI-generated analysis. Not financial advice.
PARAMUS, NJ, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”), announces it has selected a leading contract research organization (CRO) for SOTERIA, a phase 2, open-label, single-arm trial designed to evaluate the safety, tolerability, and clinical activity of Polaryx’s lead candidate, PLX-200, across four different LSDs.
“Our selection of a CRO partner marks an important milestone for us as we continue to advance the clinical development of SOTERIA and move closer to the clinic,” said Lisa Bollinger, M.D., Chief Medical Officer of Polaryx Therapeutics, Inc. “Our new partner brings meaningful experience working with and managing LSD and rare pediatric trials, as well as deep-rooted relationships with the dedicated key opinion leaders and patient advocacy groups who work closely with patients and their families.”
Polaryx continues to pursue its mission of addressing significant unmet medical needs in rare pediatric disorders by responsibly advancing programs that have the potential to deliver meaningful therapeutic options for patients and their families.
The SOTERIA trial represents a flexible and resource‑efficient mechanism to continue the clinical development of PLX‑200 across multiple LSDs. Polaryx received a safe to proceed letter from the FDA in October 2025 and continues to actively work with its contract research organization (CRO) to initiate the trial in the first half of 2026.
About PLX-200
Polaryx’s lead drug candidate, PLX-200, is an orally available compound comprised of gemfibrozil. Gemfibrozil is an FDA-approved lipid regulating agent in the fibrate family which has only been approved in a capsule form for adult patients with very high elevations of serum triglyceride levels to decrease serum triglycerides and very low-density lipoprotein cholesterol and increase high density lipoprotein cholesterol. The ability of gemfibrozil to cross the blood-brain barrier (“BBB”) has also been documented in third-party preclinical trials and safe use of gemfibrozil in adults has also been well-established over several decades of clinical investigation and commercial use, which we believe accelerates clinical development and reduces associated costs. We believe the unique ability of PLX-200 to cross the BBB, along with its widely applicable mechanism of action, positions PLX-200 to potentially address the immense unmet need in multiple rare, catastrophic LSD indications.
About the SOTERIA Trial
SOTERIA is a Phase 2, open-label, single arm trial intended to assess the safety, tolerability, and clinical activity of Polaryx’s lead drug candidate, PLX-200, in CLN2, CLN3, Krabbe disease, and Sandhoff disease, four different LSDs whose patient populations Polaryx believes represent approximately one quarter of the LSD population. SOTERIA is designed to be flexible, resource-efficient, and provide important data and information important to PLX-200’s future clinical development. Polaryx received a safe to proceed letter in October 2025 from the FDA and plans to initiate SOTERIA in the first half of 2026 in trial sites in the United States as well as in Europe and Asia or other foreign jurisdictions. Designed with a high degree of flexibility, SOTERIA represents a resource-efficient opportunity to validate PLX-200’s preclinical science across multiple LSDs while gathering data that will be invaluable in planning PLX-200’s future development pathway, including the initiation of potentially pivotal trials. For the CLN2 and CLN3 cohorts, although the entire trial is open label, these cohorts will incorporate analyses comparing natural history data as a control arm to PLX-200’s treated arm. A natural history study is a preplanned observational study intended to track the course of the disease. Should the data demonstrate compelling clinical activity, Polaryx may seek conditional marketing authorization.
About Polaryx Therapeutics
Polaryx Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing patient-friendly small molecule and gene therapy treatments for rare orphan lysosomal storage disorders (LSDs). Founded in 2014, Polaryx seeks to deliver safe, effective, and patient-friendly treatments that address the underlying pathophysiology of these catastrophic diseases and their significant unmet need. Our approach integrates small molecule therapies, including a combination therapy, and a gene therapy, positioning us to potentially address both the genetic and downstream pathological features of LSDs. Our small molecule drug candidates share similar modes of action that have been demonstrated to address lysosomal dysfunction, neuroinflammation, and neuronal loss in our validated animal models that closely mimic human clinical phenotypes. Our most advanced product candidate, PLX-200, targets several LSDs and we intend to launch SOTERIA, a Phase 2 basket trial, to evaluate PLX-200’s safety and efficacy. For more information, please visit www.polaryx.com.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Polaryx’s clinical development plans for PLX-200, including the timing for initiation of the SOTERIA trial. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Polaryx believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Polaryx’s filings with the U.S. Securities and Exchange Commission (the SEC), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Polaryx’s clinical trials; expectations regarding the timing, completion and outcome of Polaryx’s clinical trials; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Polaryx’s Registration Statement on Form S-1, as amended, filed with the SEC on January 27, 2026 and subsequent disclosure documents Polaryx may file with the SEC. Polaryx claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Polaryx expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Media Contact:
Jules Abraham
Managing Director, Communications
CORE IR
(212) 655-0924
Julesa@coreir.com
Investor Contacts:
CORE IR
(212) 655-0924
investor@polaryx.com
FAQ
What did Polaryx (PLYX) announce about the SOTERIA Phase 2 trial on February 17, 2026?
What is the design of the SOTERIA trial for PLX-200 (PLYX)?
Has Polaryx (PLYX) cleared regulatory requirements to begin SOTERIA?
How does the selected CRO support Polaryx's (PLYX) SOTERIA development timeline?
What are the limitations of SOTERIA's trial design for investors following Polaryx (PLYX)?
