Alert: Claims Focus on Alleged Misrepresentations About the Phase 3 LEVEL Trial of TNX-103. Tenax shares lost nearly 90% of their value after an upsized study powered above 95% missed both its 6-minute walk primary endpoint and its key secondary endpoint.

NEW YORK, Nov. 11, 2026 /PRNewswire/ — Levi & Korsinsky, LLP reminds purchasers of Tenax Therapeutics, Inc. (NASDAQ: TENX) securities that a biotech securities class action is pending on behalf of investors who bought between November 13, 2023 and August 7, 2026. You may be entitled to compensation without payment of any out-of-pocket fees. Find out if you might qualify for recovery or call (212) 363-7500.

Tenax shares lost 89.77% of their value on August 10, 2026, when the Company reported that TNX-103 (oral levosimendan) missed both the 6-minute walk distance (6MWD) primary endpoint and the Kansas City Cardiomyopathy Questionnaire (KCCQ) key secondary endpoint in its Phase 3 LEVEL trial. That Phase 3 endpoint failure followed an expansion of the study’s enrollment target from 152 to 230 patients and an increase in its statistical power to over 95%. Investors have until December 28, 2026 to seek lead plaintiff status.

How a Phase 3 Endpoint Failure Became a Biotech Securities Case

A development-stage drug company with no approved product generates no product sales, so its valuation rides on whether a pivotal study clears its prespecified endpoint. Tenax prioritized the 12-week LEVEL trial ahead of its imatinib program, staking its lead asset on a placebo-corrected 6MWD gain in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The action contends that investors were not told TNX-103 was less effective than represented, leaving its clinical prospects overstated while the trial advanced.

Enrollment Expansion and the Alleged Efficacy Gap

The Phase 2 HELP study had produced a reported 29-meter 6MWD treatment effect in 36 patients receiving weekly intravenous levosimendan. As pleaded, the Company built its oral Phase 3 program on those results and activated more than 50 North American sites. Plaintiffs allege the August 2026 readout exposed an efficacy gap that the Company’s prior statements had not disclosed.

“The complaint raises serious questions about whether investors received accurate information about how TNX-103 would perform on the 6-minute walk endpoint. The LEVEL study was enlarged and powered above 95%, yet it missed both its primary and key secondary endpoints, according to the Company’s own topline report.” — Joseph E. Levi, Esq.

Alleged LEVEL Trial Shortfall by the Numbers

• Trial execution: 241 patients randomized in about 24 months, with 2% missing primary endpoint data
• Primary endpoint (6MWD versus placebo): not met
• Key secondary endpoint (KCCQ total symptom score): not met
• Patients below the 333-meter median baseline walk: 26.3-meter placebo-corrected improvement (95% confidence interval of 6 to 47 meters)
• Patients above the median: the placebo group outwalked the levosimendan group by 17.6 meters

Submit your information now or call (212) 363-7500.

WHY LEVI & KORSINSKY — Ranked in ISS Securities Class Action Services’ Top 50 Report for seven consecutive years, Levi & Korsinsky, LLP is a nationally recognized leader in shareholder rights litigation. With a team of over 70 professionals, the firm has recovered hundreds of millions of dollars for investors. Investors who suffered losses have until December 28, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the TENX Lawsuit

Q: How much did TENX stock drop? A: Shares fell approximately 89.77%, a decline of $12.06 per share, after the Company disclosed on August 10, 2026 that its Phase 3 LEVEL trial of TNX-103 did not meet its primary endpoint of improvement in 6-minute walk distance versus placebo or its key secondary endpoint. Investors who purchased shares during the Class Period at allegedly artificially inflated prices and suffered losses may be eligible to seek compensation.

Q: What specific misstatements does the TENX lawsuit allege? A: The complaint alleges Tenax Therapeutics, Inc. made materially false or misleading statements regarding the efficacy of TNX-103 and the claimed “derisked” status of the Phase 3 LEVEL study, while failing to disclose that the drug was less effective than represented and that its clinical, regulatory, and commercial prospects were overstated. When the Company disclosed that LEVEL missed its primary and key secondary endpoints, the stock price declined sharply.

Q: When did Tenax Therapeutics allegedly mislead investors? A: The Class Period runs from November 13, 2023 to August 7, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.

Q: What documents do I need to submit my information? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

Q: What happens after I contact Levi & Korsinsky? A: An attorney will review your trading history at no cost and provide an initial assessment of your potential eligibility.

Q: What if I already sold my TENX shares — can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.

Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, such cases are generally handled on a contingency basis, with any attorneys’ fees and expenses subject to court approval.

Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of the investor’s country of residence.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171

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