TENX DEADLINE: Levi & Korsinsky Reminds Tenax Therapeutics, Inc. Investors of Upcoming Securities Class Action Deadline

The lawsuit asserts that Tenax Therapeutics used an FDA-cleared IND and an FDA-reviewed trial expansion to build confidence in TNX-103. The Phase 3 LEVEL study then failed, and TENX shares fell 89.77%

NEW YORK, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies shareholders of Tenax Therapeutics, Inc. (NASDAQ: TENX) that a securities class action is pending on behalf of investors who purchased Tenax securities between November 13, 2023 and August 7, 2026. Submit your information now or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

Tenax shares fell approximately $12.06, or 89.77%, to close at approximately $1.38 on August 10, 2026. The drop came after the Company reported that TNX-103 missed its primary and key secondary endpoints in the Phase 3 LEVEL study. The complaint alleges investors paid inflated prices for a program that management repeatedly tied to FDA clearance and FDA protocol review.

IMPORTANT DATE: December 28, 2026 is the deadline for investors to seek appointment as lead plaintiff.

FDA Milestones Cited in Tenax Disclosures

The lawsuit contends that the Company used regulatory progress to signal clinical confidence. Touchpoints identified in the complaint include:

• November 13, 2023: Tenax announced FDA clearance of its Investigational New Drug Application for TNX-103. It said the Phase 3 program was designed to exceed the minimal clinically important difference.
• Exposure targets: The same release said the program would satisfy the FDA's request for drug exposure in 300 patients for 6 months and 100 patients for 1 year. These are minimum requirements under ICH guidelines.
• March 28, 2024: A Form 10-K cited FDA input on the oral levosimendan protocol and clinical development program.
• March 5, 2025: Tenax announced the FDA had "completed their review" of an updated Phase 3 plan with expanded enrollment. The review also covered the protocol for a second registrational study, LEVEL-2.
• March 25, 2025: A Form 10-K pointed to already-approved drugs with "well-established safety profiles from millions of patients."

Where Regulatory Progress Allegedly Diverged From Clinical Reality

As alleged, none of these milestones showed that TNX-103 would outperform placebo. The complaint also alleges investors were not told the drug was less effective than represented. The topline data then showed TNX-103 did not meet its 6-minute walk distance endpoint versus placebo or its Kansas City Cardiomyopathy Questionnaire total symptom score endpoint.

"An IND clearance or an FDA protocol review tells investors a trial may proceed, not that a drug will succeed. The complaint alleges Tenax's statements about TNX-103 blurred that distinction while the Phase 3 LEVEL study was underway," said Joseph E. Levi, Esq., managing partner of Levi & Korsinsky, LLP.

Exchange Act Claims Before the Middle District of North Carolina

The action asserts claims under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5. It also asserts Section 20(a) claims against individual officers. In practical terms, these provisions let purchasers seek damages tied to materially false or misleading public statements.

Find out if you might qualify to recover losses or call (212) 363-7500.

WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.

Frequently Asked Questions About the TENX Lawsuit

Q: What is the TENX class action lawsuit about? A: A securities class action has been filed against Tenax Therapeutics, Inc. (NASDAQ: TENX) alleging materially false and misleading statements between November 13, 2023 and August 7, 2026. Shares fell approximately 89.77% after the Company disclosed that its Phase 3 LEVEL trial of TNX-103 did not meet its primary endpoint of improvement in 6-minute walk distance versus placebo. Investors who purchased shares during the Class Period and suffered losses may be eligible to seek compensation.

Q: Who is eligible to join the TENX investor lawsuit? A: Investors who purchased TENX stock or securities between November 13, 2023 and August 7, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses -- not on whether you still hold the shares.

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 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, they 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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