Polaryx Therapeutics Announces Direct Listing on Nasdaq; Shares to Begin Trading Under the Symbol “PLYX”

Rhea-AI Summary

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.

Positive

• Direct listing on Nasdaq effective February 2, 2026, increasing market visibility
• Planned Phase 2 SOTERIA launch in H1 2026 for lead candidate PLX-200
• Advisory team named: Maxim Group (financial) and major law firms engaged

Negative

• SOTERIA is a single-arm, open-label Phase 2 basket trial, which may limit comparative evidence strength
• No financial results, guidance, or capital-raising details disclosed in the announcement

Key Figures

Trial phase: Phase 2 Trial design: Single arm, open-label Planned launch window: First half of 2026

3 metrics

Trial phase Phase 2 SOTERIA trial for lead candidate PLX-200

Trial design Single arm, open-label SOTERIA Phase 2 basket trial structure

Planned launch window First half of 2026 Expected initiation of SOTERIA Phase 2 trial

Market Reality Check

Price: $2.92

normal vol

$2.92 Last Close

Market Pulse Summary

This announcement highlights Polaryx’s transition to trading on the Nasdaq Capital Market under the ...

Analysis

This announcement highlights Polaryx’s transition to trading on the Nasdaq Capital Market under the symbol PLYX and the planned launch of its pivotal Phase 2 SOTERIA trial for PLX-200 in the first half of 2026. Investors may focus on progress toward trial initiation, the basket trial design across lysosomal storage disorders, and subsequent clinical readouts as key markers of execution and development risk.

Key Terms

direct listing, nasdaq capital market, ticker symbol, single arm, +3 more

7 terms

direct listing financial

"Maxim Group LLC acted as the exclusive financial advisor to Polaryx in connection with the direct listing."

A direct listing is a way for a company to become publicly available for trading without issuing new shares or raising additional money beforehand. Instead, existing shares are simply made available for purchase on the stock market, allowing current investors and employees to sell their holdings. This process can offer a simpler and faster way for a company to go public, giving investors quicker access to buy and sell shares.

nasdaq capital market financial

"shares of the Company’s common stock will start trading today on the Nasdaq Capital Market (“Nasdaq”)"

The Nasdaq Capital Market is a platform where smaller, emerging companies can list their shares for trading by investors. It provides these companies with access to funding and visibility, helping them grow, much like a local marketplace where new vendors can introduce their products to potential customers. For investors, it offers opportunities to discover early-stage companies with growth potential.

ticker symbol financial

"will start trading today on the Nasdaq Capital Market (“Nasdaq”) under the ticker symbol “PLYX”."

A ticker symbol is a short, unique code of letters or characters that identifies a publicly traded security on an exchange — like a car’s license plate or a person’s nickname for the market. Investors use ticker symbols to look up live prices, place trades, and follow news; using the correct symbol makes sure you’re tracking or buying the intended stock, bond, or fund and helps avoid costly mix-ups.

single arm medical

"SOTERIA, our single arm, open-label Phase 2 trial with a planned launch in the first half of 2026."

A single-arm study is a clinical trial that tests one treatment group without a separate control or placebo group. For investors, it matters because results from single-arm trials can be quicker and require fewer patients, but they offer less direct evidence of benefit versus alternatives, increasing uncertainty about safety, effectiveness, regulatory approval and the commercial value of the therapy — like judging a recipe by tasting only one version instead of comparing several.

open-label medical

"SOTERIA, our single arm, open-label Phase 2 trial with a planned launch in the first half of 2026."

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

phase 2 medical

"SOTERIA, our single arm, open-label Phase 2 trial with a planned launch in the first half of 2026."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

basket trial medical

"clinical activity for multiple indications within lysosomal storage disorder in a basket trial"

A basket trial is a type of clinical study that tests one treatment across multiple diseases or patient groups that share a common biological feature, like a genetic marker. Think of it as trying one key in several different locks that use the same mechanism; positive results can speed development and expand a drug’s potential market, while mixed results can raise uncertainty about which patient groups will benefit and how regulators will view approvals.

AI-generated analysis. Not financial advice.

PARAMUS, NJ, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics (“Polaryx” or the “Company”) a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”), announced that shares of the Company’s common stock will start trading today on the Nasdaq Capital Market (“Nasdaq”) under the ticker symbol “PLYX”.

“We are pleased to announce that Polaryx’s common stock will begin trading on the Nasdaq Stock Market today,” said Alex Yang, Polaryx’s Chairman and Chief Executive Officer. “This listing is a notable milestone that opens a new and exciting chapter in our development, and we look forward to the many opportunities that lie ahead as we work to develop therapies for devastating rare orphan lysosomal disorders. This achievement is also an important testament to the dedication and hard work of the entire Polaryx team.”

“Polaryx is embarking on a pivotal and promising phase especially due to SOTERIA, our single arm, open-label Phase 2 trial with a planned launch in the first half of 2026. SOTERIA will assess our lead drug candidate PLX-200’s safety, tolerability, and clinical activity for multiple indications within lysosomal storage disorder in a basket trial and represents a particularly unique, powerful and resource-efficient trial design and corporate catalyst.”

Maxim Group LLC acted as the exclusive financial advisor to Polaryx in connection with the direct listing. Gibson, Dunn & Crutcher LLP served as legal advisor and Brownstein Hyatt Farber Schreck, LLP served as Nevada counsel. 

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

When did Polaryx (PLYX) begin trading on Nasdaq and under what ticker?

Polaryx began trading on Nasdaq on February 2, 2026 under the ticker PLYX. According to the company, the direct listing marks a new chapter for its development and public-market access.

What is the SOTERIA trial and when will Polaryx (PLYX) start it?

SOTERIA is a single-arm, open-label Phase 2 basket trial for PLX-200 planned to launch in H1 2026. According to the company, it will assess safety, tolerability, and clinical activity across multiple LSD indications.

What does the Nasdaq direct listing mean for Polaryx (PLYX) shareholders?

The direct listing provides immediate public-market liquidity and visibility without issuing new shares. According to the company, it represents a milestone opening access to public investors and market trading for existing holders.

Who advised Polaryx (PLYX) on the direct listing transaction?

Maxim Group acted as exclusive financial advisor; Gibson Dunn served as legal advisor and Brownstein Hyatt Farber Schreck served as Nevada counsel. According to the company, these advisors supported the direct listing process.

What are the near-term clinical milestones investors should watch for PLYX in 2026?

The primary near-term milestone is SOTERIA’s planned launch in H1 2026 for PLX-200 and initial safety/tolerability readouts thereafter. According to the company, SOTERIA is positioned as a corporate catalyst for multiple LSD indications.