Time-Sensitive: Allegations Focus on TNX-103 Regulatory and Commercial Prospects Representations. The lawsuit asserts that management overstated the drug's approval pathway before the Phase 3 LEVEL trial missed its primary endpoint.
TENX INVESTOR ALERT
NEW YORK, Nov. 12, 2026 /PRNewswire/ -- SueWallSt alerts investors in Tenax Therapeutics, Inc. (NASDAQ: TENX) of a pending securities class action. Class Period: November 13, 2023 through August 7, 2026. Check if you might be eligible to recover your investment losses or contact Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt.
In this biopharmaceutical securities case, TENX shares fell 89.77% in a single session. As alleged, the decline came after the Company raised approximately $134 million in gross proceeds from offerings and private placements during the Class Period. The Court has set December 28, 2026 as the deadline to apply for lead plaintiff appointment.
"Investors deserve transparency about material risks that could affect their investments, particularly a development-stage company's path to approval. The complaint alleges that Tenax told the market it could win approval on a six-minute walk endpoint and expected to file in the U.S. and abroad, while TNX-103's prospects were allegedly overstated." -- Joseph E. Levi, Esq.
TNX-103 Regulatory and Commercial Prospects: The Alleged Approval-Path Statements
At the November 13, 2024 Guggenheim Healthcare Innovation Conference, management told investors "we were told that we would be able to get approval with six minute walk as a primary endpoint." Management also said a second Phase 3 trial would not wait for LEVEL topline data because "there's not something that we need to learn from the first trial in order to start the second." That same day, management described its goal "to make levosimendan the first approved treatment for the millions of individuals affected with PH-HFpEF" (pulmonary hypertension in heart failure with preserved ejection fraction).
Filing Expectations Allegedly Ran Ahead of the Data
In March 2025, the Company said the FDA had "completed their review" of its updated Phase 3 plan. It also said two registrational studies were expected to "satisfy the requirements, including the safety data expectations, to file in the U.S. and other geographies," and it repeated that message in August 2025. The action claims this outlook was overly aggressive and failed to account for how baseline disease burden would shape treatment response.
Unmet-Need Cardiopulmonary Drugs and the Regulatory Bar
- No FDA-approved drug existed for PH-HFpEF, and the Company highlighted this while positioning TNX-103 as a first-in-disease therapy.
- Management cited a pulmonary hypertension "precedent for six-minute walk as the primary endpoint" and acknowledged that cardiovascular programs typically require an outcomes assessment.
- The Company chose two trials at P05 over a single trial at P01. Management said a successful first trial would allow it to raise money for the second.
- The LEVEL study's statistical power was raised to over 95% under the FDA-reviewed plan.
- The Company said expanded U.S. intellectual property protections secured "the future commercial value of TNX-103."
- LEVEL missed its six-minute walk distance primary endpoint and its key Kansas City Cardiomyopathy Questionnaire secondary endpoint.
Learn more about the case or call (888) SueWallSt.
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Frequently Asked Questions About the TENX Lawsuit
Q: What specific misstatements does the TENX lawsuit allege? A: The complaint alleges Tenax Therapeutics, Inc. made materially false or misleading statements during the Class Period regarding the efficacy and the clinical, regulatory, and commercial prospects of its lead product candidate, TNX-103 (levosimendan). When the Company disclosed that the Phase 3 LEVEL trial did not meet its primary endpoint, the stock price declined sharply.
Q: When did Tenax Therapeutics, Inc. 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 court was the TENX class action filed in? A: The case was filed in the United States District Court for the Middle District of North Carolina, governed by the Private Securities Litigation Reform Act of 1995.
Q: What do TENX investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible as an absent class member.
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 if Tenax Therapeutics, Inc. goes bankrupt before the case resolves? A: Securities class action claims may survive bankruptcy in many circumstances. D&O insurance policies are frequently a potential source of settlement funds.
Q: Can I join a different law firm's lawsuit instead? A: Yes. Investors may choose which law firm to contact. Multiple firms often file competing complaints. The court may consolidate related cases and appoint a single lead counsel.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
Tel: (888) SueWallSt
Fax: (212) 363-7171
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SOURCE SueWallSt.com

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