Investors who bought or otherwise acquired Tenax Therapeutics securities between November 13, 2023 and August 7, 2026 may be covered by a proposed class action alleging Tenax overstated the prospects of its heart drug candidate TNX-103 before the Phase 3 LEVEL trial missed its primary endpoint. No class has been certified and there is nothing to file yet.
Allegations Only · No Settlement Yet
This article describes a class action complaint. The statements below are unproven allegations. Tenax Therapeutics and the individual defendants have not been found liable, there is no certified class, and nothing to claim at this time. This page is informational and is not legal advice.
What Is the Tenax Lawsuit About?
Katz v. Tenax Therapeutics, Inc., No. 1:26-cv-01264, was filed October 26, 2026 in the U.S. District Court for the Middle District of North Carolina. Tenax, a development-stage drug company based in Chapel Hill whose stock trades on Nasdaq as TENX, had staked its pipeline on TNX-103, an oral form of the drug levosimendan, for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).The complaint alleges that for nearly three years Tenax and its senior officers described the TNX-103 program as “derisked” and pointed to earlier Phase 2 results as evidence it would work, while failing to disclose that the drug was less effective than investors were led to believe. On August 10, 2026, Tenax reported that the Phase 3 LEVEL trial missed its primary and key secondary endpoints, and the complaint says the stock fell about 90% that day. Pomerantz LLP and Schall, Brown & Schwartz LLP filed the complaint, with Schiller & Schiller, PLLC as local counsel. No judge had been listed on the docket as of October 27, 2026.
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The “Derisked” Statements About TNX-103
The class period starts November 13, 2023, when Tenax announced that the FDA had cleared its investigational new drug application for TNX-103 and that the LEVEL Phase 3 trial would begin. That release said the Phase 3 program had been “designed to exceed the minimal clinically important difference,” and quoted Chief Medical Officer Stuart Rich citing proof-of-concept data from the Phase 2 HELP study.The complaint quotes a series of later statements. At a November 13, 2024 investor conference, Rich said the company had been told it could seek approval with six-minute walk distance as the primary endpoint, and CEO Christopher Giordano said that while 10 to 15 meters would be considered beneficial, “we got 29 in HELP.” In March 2025 Tenax said the FDA had completed its review of an expanded plan that raised the LEVEL study’s statistical power to over 95%, and its annual report filed March 25, 2025 described a “derisked approach” of developing already-approved drugs. On a November 13, 2025 call, Rich gave three reasons the study had been derisked: HELP had confirmed the drug’s effect on heart pressures, LEVEL was enriched with patients resembling the HELP responders, and daily oral dosing was expected to work better than the weekly infusions used in HELP.
During the same period, the complaint says, Tenax raised about $134 million from a February 2024 public offering, a roughly $100 million private placement in August 2024 and a roughly $25 million private placement in March 2025. The complaint offers those raises as motive.
What the Complaint Says Was Misleading
The complaint alleges that the statements were materially false or misleading because the defendants failed to disclose that TNX-103 was less effective than they had led investors to believe, and that its clinical, regulatory and commercial prospects were therefore overstated. It does not cite internal documents or confidential witnesses; the scienter allegations rest on the officers’ positions, their repeated statements about the drug and the capital raised during the class period.The August 10, 2026 LEVEL Results and Stock Drop
On August 10, 2026, Tenax announced topline results showing TNX-103 “did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score.” On the conference call that followed, as quoted in the complaint, Giordano said Tenax “did not anticipate the impact disease burden would have on the treatment response”: patients below the median baseline walk of 333 meters improved by 26.3 meters over placebo, while healthier patients on placebo outwalked those on the drug by 17.6 meters.According to the complaint, Tenax stock fell about $12.06 a share, or 89.77%, to close at about $1.38 on August 10, 2026. The next day, the complaint says, several analysts cut their ratings or price targets, including Guggenheim Securities, which lowered its target from $40 to $4.
Who Is Being Sued and Under Which Laws
The defendants are Tenax Therapeutics, Inc.; President and Chief Executive Officer Christopher T. Giordano; Chief Medical Officer Stuart Rich; Chief Financial Officer Thomas A. McGauley, in that role since December 2, 2024; and two former interim CFOs, Eliot M. Lurier (until December 8, 2023) and Lawrence R. Hoffman (January 9 to December 2, 2024).Count I claims violations of Section 10(b) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 against all defendants. Count II claims the individual defendants are liable as controlling persons under Section 20(a). The complaint relies on the fraud-on-the-market presumption of reliance and seeks damages, interest, fees and costs, and a jury trial.
Who Is in the Proposed Class?
The proposed class is all persons and entities, other than the defendants, who purchased or otherwise acquired Tenax securities between November 13, 2023 and August 7, 2026, inclusive, and were damaged when the alleged truth was revealed. Tenax’s officers and directors, their immediate families and entities the defendants control are excluded. A court has not certified the class.What Happens Next
Under the Private Securities Litigation Reform Act, the court will appoint a lead plaintiff and lead counsel, usually after a 60-day window that opens when notice of the suit is published. A consolidated or amended complaint typically follows, and defendants in securities cases commonly move to dismiss, which pauses discovery while the motion is pending. Tenax had not filed a response as of October 27, 2026.There is nothing to claim in the Tenax case now. If it settles, investors in the settlement class would normally receive a notice and a claim form that asks for their trading records. Other drug-developer investor suits on OCA include the Ardelyx securities class action.
Questions
Is there a Tenax Therapeutics settlement?
No. Katz v. Tenax Therapeutics, Inc. was filed October 26, 2026 in the U.S. District Court for the Middle District of North Carolina and is at the complaint stage. No class has been certified, there is no settlement and there is nothing to claim.
What happened in the Tenax LEVEL trial?
On August 10, 2026, Tenax reported that TNX-103 did not meet the LEVEL trial’s primary endpoint, improvement in six-minute walk distance versus placebo, or its key secondary endpoint, the Kansas City Cardiomyopathy Questionnaire total symptom score. Tenax said patients with lower baseline walk distances improved, while healthier patients on the drug did worse than placebo.
Who is being sued in the Tenax securities case?
The complaint names Tenax Therapeutics, Inc.; President and CEO Christopher T. Giordano; Chief Medical Officer Stuart Rich; current CFO Thomas A. McGauley; and former interim CFOs Eliot M. Lurier and Lawrence R. Hoffman. It claims violations of Section 10(b) of the Securities Exchange Act and Rule 10b-5 against all defendants, and of Section 20(a) against the individual defendants.
How does a lead plaintiff get chosen in a securities class action?
Under the Private Securities Litigation Reform Act, notice of a new securities class action is published, and class members have 60 days from that notice to ask the court to be appointed lead plaintiff. The court generally presumes the movant with the largest financial interest is the most adequate plaintiff. Class members do not need to seek that role to remain part of the proposed class.
