Tenax Therapeutics (NASDAQ: TENX) Securities Class Action: TNX-103 LEVEL Trial and December 28, 2026 Lead Plaintiff Deadline

The lawsuit alleges that Tenax overstated the clinical prospects of TNX-103, an oral formulation of levosimendan being developed for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). Plaintiff alleges Tenax repeatedly emphasized positive Phase 2 results, FDA alignment on its Phase 3 program, its patient-selection strategy, the drug's prior clinical experience, and a supposedly 'derisked' development approach — while allegedly overstating how likely TNX-103 was to show clinically meaningful efficacy in the Phase 3 population.

The best description is a Phase 2-to-Phase 3 translation and 'derisked' clinical-development disclosure case — not simply that 'Tenax's drug failed.' Clinical trials fail routinely, and a failed Phase 3 trial does not by itself establish securities fraud. The allegations have not been proven.

Tenax is a development-stage pharmaceutical company focused on cardiopulmonary therapies, incorporated in Delaware and headquartered in Chapel Hill, North Carolina, with no approved drug product for sale. Its prioritized product candidate is TNX-103, an oral formulation of levosimendan.

Levosimendan is a K-ATP channel activator and calcium sensitizer originally developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and intravenous levosimendan has been authorized in roughly 60 countries for that indication. Importantly, it is not approved in the United States or Canada, and Tenax is developing an oral version for a different condition (PH-HFpEF) — so it would be inaccurate to say TNX-103 was 'already FDA-approved.'

PH-HFpEF is pulmonary hypertension associated with heart failure with preserved ejection fraction — a difficult cardiopulmonary condition in which patients have elevated pulmonary pressures and reduced exercise capacity while the heart's left-ventricular ejection fraction remains preserved. According to Tenax, no therapy has yet been approved by the FDA specifically for PH-HFpEF, which is part of why the program drew investor attention.

HELP was a relatively small Phase 2 levosimendan study and is foundational to the securities case. After an initial open-label levosimendan period (44 patients), 37 patients who showed a predefined hemodynamic response were randomized — 18 to levosimendan and 19 to placebo.

Here the balance matters: HELP did not meet its prespecified primary endpoint (exercise pulmonary-capillary wedge pressure, p = 0.65). But it produced a statistically significant, approximately 29.3-meter placebo-adjusted improvement in six-minute walk distance (6MWD, p = 0.033) — a secondary endpoint that later became central to the Phase 3 program. So it would be wrong to say 'HELP was a successful Phase 2 trial that met its primary endpoint.' That ~29-meter result became a central reason for management's optimism: the complaint quotes CEO Christopher Giordano telling investors in November 2024 that roughly 10–15 meters would be clinically beneficial, while 'we got 29 in HELP.'

Six-minute walk distance (6MWD) measures how far a patient can walk in six minutes and is commonly used to assess functional capacity in cardiopulmonary disease. A Phase 2 signal on such a measure can fail to reproduce in a larger Phase 3 trial for many reasons — a larger or different patient population, different dosing or duration, different endpoint construction, regression to the mean, statistical variation, disease heterogeneity, and placebo response, among others.

That general clinical-development risk is especially relevant here because HELP was small and included a responder-enrichment step (randomizing only patients who had already responded in the open-label phase) before randomization — which can make a Phase 2 effect look stronger than what a broader Phase 3 population later shows.

No. The class period begins November 13, 2023, when Tenax announced the FDA had cleared its Investigational New Drug (IND) application for TNX-103 so the LEVEL trial could proceed, with 6MWD as the Phase 3 primary endpoint. But FDA clearance of an IND only permits clinical investigation to proceed — it is not marketing approval, not an efficacy finding, and not a prediction the trial will succeed.

Similarly, Tenax said the FDA agreed that 6MWD could serve as the primary Phase 3 endpoint. That is meaningful regulatory progress, but it means 6MWD was an acceptable efficacy endpoint to evaluate — not that the FDA agreed TNX-103 would actually improve 6MWD. This distinction (FDA endpoint agreement ≠ efficacy agreement) runs throughout the case.

This is the central linguistic issue, and context matters — the word was used in two different senses. In its SEC filings, Tenax often described its strategy as 'derisked' because levosimendan had already been used extensively in humans, was authorized outside the United States for another indication, had an established safety record, and was being developed with experienced cardiopulmonary experts. In that usage, 'derisked' does not necessarily mean Phase 3 efficacy was guaranteed.

The complaint leans more heavily on a November 2025 key-opinion-leader (KOL) presentation, where management discussed how LEVEL had been 'derisked' in terms more directly connected to efficacy — citing HELP's results, the enrollment of patients resembling HELP responders, prior oral-dosing experience, and a design intended to give enrolled patients the 'best opportunity to have a favorable response.' Plaintiff alleges that efficacy-oriented language went beyond ordinary optimism; the page keeps the two senses of 'derisked' distinct rather than collapsing them.

In March 2025, Tenax announced that the FDA had reviewed an updated Phase 3 development plan and that an amendment expanded LEVEL enrollment and increased its statistical power to more than 95%. It is important not to misread that: statistical power is not the probability that the drug works. A trial with 95% power generally means that, if the assumed treatment effect and statistical assumptions are correct, the study has roughly a 95% probability of detecting that specified effect at the chosen threshold. It does not mean there was a '95% chance the trial would succeed,' and Tenax did not say there was.

Yes. Tenax's SEC filings repeatedly stated that it had no approved U.S. product, that clinical-trial outcomes were uncertain, that favorable early-stage data might not translate into approval, and that FDA discussions or trial-design agreements did not guarantee success — and its 2025 annual report expressly warned that the LEVEL and LEVEL-2 outcomes were uncertain and that approval was not assured even after extensive testing and regulatory discussions.

Those disclosures are part of the picture, but they do not by themselves resolve the case. Plaintiff's theory is that the specific, optimistic efficacy and 'derisked' statements went beyond these generic warnings and lacked a reasonable basis when made; Tenax will likely emphasize that HELP produced genuine positive data, the Phase 3 design was reviewed with the FDA, the trial was well powered, there is no allegation of fabricated data, and the adverse outcome became knowable only after LEVEL was unblinded. This page does not resolve that dispute.

The proposed class ends August 7, 2026, the last trading day before the August 10 disclosure. On August 10, Tenax reported that the Phase 3 LEVEL trial (241 patients) failed its primary endpoint: at Week 12, TNX-103 patients improved about 14.0 meters on 6MWD versus about 10.4 meters for placebo — a placebo-adjusted difference of only about 3.5 meters, p = 0.63. The key secondary endpoint, the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score, also showed essentially no difference (about 0.1 points). So both headline registrational efficacy measures failed to distinguish TNX-103 from placebo in the overall study population.

Yes — the trial was not biologically 'empty,' and the company's side belongs on the record. Tenax reported that a prespecified subgroup of more-impaired patients (those walking less than the median 333 meters at baseline) showed an approximately 26.3-meter placebo-adjusted improvement (95% CI about 6.0–46.7 meters, nominal p = 0.0112), along with favorable exploratory findings on NT-proBNP (about a 49% greater reduction versus placebo) and right ventricular systolic pressure (about 3.5 mmHg). But these subgroup and exploratory p-values were nominal — not adjusted for multiple comparisons — and Tenax itself cautioned that these analyses do not establish efficacy in the overall population.

Management's explanation was that the trial enrolled too broad a population: CEO Giordano said Tenax 'did not anticipate the impact disease burden would have on treatment response,' with more-impaired patients appearing to benefit more and healthier patients having less room to improve. That cuts both ways — among patients above the median baseline walking distance, placebo patients actually outperformed TNX-103 patients by roughly 17.6 meters, an adverse data point that sits alongside the positive lower-function subgroup. Importantly, the LEVEL failure was an efficacy failure, not a safety failure: TNX-103 was generally described as safe and well tolerated, with serious adverse events roughly balanced (about 10.8% versus 10.7% on placebo).

According to the complaint, TENX fell approximately $12.06 per share, or about 89.8%, to close near $1.38 on August 10, 2026 — an extraordinary one-day decline. Multiple analysts sharply cut their price targets afterward, with reported changes including Guggenheim ($40 → $4), Chardan ($27 → $5), Canaccord ($35 → $4), Evercore ($39 → $5), and Leerink (approximately $26 → $4), and several firms also downgraded their ratings.

Yes. The complaint points to approximately $134 million of financing transactions during the class period — about $9 million in February 2024, about $100 million in August 2024, and about $25 million in March 2025 — and cites them as part of its motive theory (an alleged incentive to keep TENX inflated so the company could raise capital).

One clarification matters: these were principally issuer capital raises, not executives selling their own shares. The proceeds went to Tenax to fund its operations and clinical program, so it would be false to say 'Tenax executives sold $134 million of their own stock.' Capital raising through securities offerings is also ordinary for a pre-revenue, development-stage biotechnology company that funds trials this way — a fact that cuts against reading the financings as evidence of fraud on their own.

The currently reviewed SEC Forms 4 do not support describing this as a classic executive stock-dumping case. For example, a pre-results July 2026 filing for CEO Giordano reflects stock-option exercises rather than a discretionary open-market sale, and reviewed filings for the other named executives principally show option activity and existing holdings. Notably, after LEVEL failed, Giordano purchased additional TENX shares in September 2026. That does not decide the merits, but the stronger scienter theories here are the repeated efficacy statements, the 'derisked' narrative, the centrality of TNX-103, and the capital-raising activity — not insider selling — and Julie & Holleman does not market this as an insider-trading case.

No. Drug development is inherently uncertain, and a trial can fail even where earlier data were encouraging and management genuinely believed in the program. A securities plaintiff must separately establish that earlier statements were materially false or misleading when made and that defendants acted with the state of mind required by the federal securities laws. The Katz complaint alleges Tenax crossed that line by repeatedly characterizing the program as unusually 'derisked'; Tenax had also repeatedly disclosed that clinical-trial results and FDA approval remained uncertain.

Tenax has not abandoned TNX-103. After analyzing LEVEL — including August 29 and September 9 presentations supporting its view that more-impaired patients benefited more — the company decided to 'enrich' LEVEL-2 by narrowing the future study population toward patients it believes are more likely to respond (based on baseline exercise limitation and disease burden). To implement revised criteria, Tenax temporarily paused LEVEL-2 enrollment on October 8, 2026 and requested a Type C meeting with the FDA to discuss the overall levosimendan development program.

A few cautions: Tenax did not cancel LEVEL-2 — the pause was described as temporary — and, as of the public information reviewed for this page, the FDA has not approved any revised LEVEL-2 strategy. The honest framing is in the middle: Tenax believes LEVEL identified a potentially responsive patient population and is seeking FDA feedback on a revised approach, but whether that strategy will support an eventual approval remains uncertain. It would overstate the record to say either that 'TNX-103 has no path to approval' or that 'the subgroup guarantees an approval path.'

The proposed class period is November 13, 2023 through August 7, 2026. The complaint broadly refers to Tenax 'securities' and expressly alleges that investors acquired securities and options at artificially inflated prices, so the precise scope of any ultimately certified class is not yet determined — investors in TENX stock or options should preserve their records and obtain case-specific advice rather than assume inclusion or exclusion.

The current published PSLRA lead plaintiff deadline is December 28, 2026.

Do I Have to Become Lead Plaintiff?

Generally, no. A lead plaintiff is the investor or investor group the court appoints to actively supervise the proposed class and proposed lead counsel. Most investors remain passive class members.

Lead Plaintiff Deadline ≠ Settlement Claim Deadline

These are different dates. An eligible investor ordinarily does not need to seek lead-plaintiff appointment merely to remain a potential passive class member.

Generally, no, for the federal securities claim — an investor who sold TENX may still have a potential claim depending on matters including purchase date, sale date, the corrective disclosure, and the recognized loss. Current ownership is separately relevant to potential derivative or corporate-governance rights, discussed below.

Potentially. Tenax is incorporated in Delaware, so any shareholder derivative or internal-affairs analysis generally begins with Delaware law. Julie & Holleman LLP is evaluating whether current shareholders who owned shares at the time of potentially actionable conduct and have continued to hold may have separate corporate-governance rights relating to clinical-development disclosures and controls, board oversight of TNX-103, statements concerning trial risk, the capital-raising disclosures, and oversight of regulatory communications.

We note candidly that, compared with cases built on regulatory admissions, obvious insider selling, or accounting restatements, this is a more investigatory, weaker derivative posture — the existence of a failed trial alone does not establish a viable derivative claim, and standing depends on the specific challenged conduct and a shareholder's ownership timeline. Counsel may evaluate whether a Delaware books-and-records investigation or other steps are appropriate for a qualifying current shareholder; such an investigation would not provide access to blinded trial data, FDA communications, or privileged regulatory advice. No determination has been made that viable derivative claims exist.

Julie & Holleman LLP is investigating allegations involving Tenax Therapeutics, TENX, TNX-103, oral levosimendan, the Phase 2 HELP and Phase 3 LEVEL and LEVEL-2 trials, PH-HFpEF, six-minute walk distance, FDA clinical-development discussions, the 'derisked' clinical-development statements, patient enrichment, the biotechnology securities disclosures, the capital raises, and corporate governance. We are interested in hearing from:

Investors With Securities Losses

Investors who purchased or otherwise acquired Tenax securities between November 13, 2023 and August 7, 2026 and suffered losses, including investors evaluating lead-plaintiff appointment before December 28, 2026.

Current Tenax Shareholders

Current shareholders who owned shares during potentially actionable conduct and have continued to hold them, and who wish to evaluate whether separate Delaware corporate-governance rights may exist.