{"success":true,"data":{"pressRelease":{"id":"130699","rtpr_id":"nGNX7GQ2s3","ticker":"TENX","exchange":"NASDAQ","all_tickers":["TENX"],"title":"Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026","author":"Globe Newswire","published_at":"2026-08-29T12:21:22.090Z","article_body":"In patients with a baseline 6MWD below the trial median of 333 meters,\ntreatment with TNX-103 resulted in a 26.3-meter improvement compared to\nplacebo (p = 0.0112)\n\nIn the same patient population, TNX-103 produced a 47% reduction in NT-proBNP\n(p < 0.0001) and a 4.9 mmHg reduction in RVSP (p = 0.009) compared to placebo\n\nWith full statistics analysis now complete, Company confirms TNX-103’s\nbiological effects include marked reductions in pulmonary artery pressure and\nNT-proBNP, a biomarker reflecting increased cardiac wall stress. Results will\ninform protocol population enrichment and changes to overall registrational\npath\n\nCHAPEL HILL, N.C., Aug. 29, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc.\n(Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”)\ntoday announced that additional results from the Phase 3 LEVEL clinical trial\nevaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension\ndue to heart failure with preserved ejection fraction (PH-HFpEF) were\npresented in a Late-Breaking Clinical Science session at the European Society\nof Cardiology (ESC) Congress 2026 in Munich, Germany.\n\nData confirmed findings from prespecified analyses which identified a\nfavorable treatment effect in patients with a lower baseline 6MWD, supported\nby consistent changes in prespecified endpoints measuring cardiac stress and\npulmonary pressures.\n\n“The independent analysis of LEVEL data we presented today sharpens what the\nearlier topline results initially indicated: patients with the lowest baseline\nwalking distance had the greatest improvement, on top of state-of-the-art\nbackground therapy. What was particularly striking was that even patients who\ndid not show a significant improvement in exercise capacity had the same\nmagnitude of reduction in cardiac wall stress and pulmonary artery pressures,\nchanges that correspond to a reduction in heart failure hospitalizations over\nlonger follow-up,” said Sanjiv Shah, MD, Director of the HFpEF Program at\nNorthwestern University Feinberg School of Medicine and LEVEL’s Principal\nInvestigator. “The magnitude of the reduction in NT-proBNP and the\naccompanying lowering of pulmonary pressure indicate that TNX-103 may provide\nclinical benefit to the majority of patients with PH-HFpEF independent of its\neffect on walk distance. The data are compelling and consistently point toward\na potential therapeutic benefit in PH-HFpEF patients.”\n\n“The full set of prespecified analyses we completed in the last week, and\nDr. Shah’s presentation of the results today, continue to emphasize that the\ntreatment effect of TNX-103 is concentrated in patients walking less than the\ntrial median of 333 meters at baseline. The finding of biologic efficacy in\nthe majority of patients in LEVEL validates that the unique mechanism of\naction demonstrated in the Phase 2 HELP study can address patient function.\nThat gives us conviction and a clear strategy to enrich LEVEL-2 for a study\npopulation of patients in whom the treatment effect is demonstrable,” said\nStuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. “LEVEL has\nbeen enormously informative in shaping what comes next, and we intend to move\nquickly on behalf of patients who currently have no approved treatment\noptions.”\n\nKey Takeaways from Late-Breaking Presentation\n\nThe Phase 3 LEVEL clinical trial (NCT05983250) randomized 241 patients with\nPH-HFpEF across 41 sites in the United States and Canada. In this population,\nthe primary endpoint of change in 6-minute walk distance (6MWD) at Week 12 did\nnot achieve statistical significance, nor did the key secondary endpoint,\nchange in Kansas City Cardiomyopathy Questionnaire total symptom score\n(KCCQ-TSS); however, marked improvements were noted in exploratory endpoints\nthat demonstrate the biologic effects of the therapy, notably N-terminal\npro-B-type natriuretic peptide (NT-proBNP) and right ventricular systolic\npressure (RVSP).\n\nSeveral key observations made in the trial, and their potential influence on\nthe future development of levosimendan for patients with pulmonary\nhypertension and heart failure, were emphasized:\n* Across the overall trial population (n = 241), TNX-103 was safe and well\ntolerated, with no significant arrhythmias.\n* This population of older, symptomatic patients presented with multiple\ncomorbidities, and was well-treated on guideline-directed medical therapy\n(GDMT): across these categories of increasing disease severity, with emphasis\nplaced on atrial fibrillation and exercise tolerance, and increasing\ntherapeutic intervention like MRAs/diuretics, and SGLT-2 inhibitors,\nlevosimendan’s benefit appears to increase.\n* An inverse linear relationship between baseline 6MWD and treatment effect\nwas described and demonstrated not to be explained by regression to the mean.\nPatients in LEVEL whose baseline 6MWD match those reported in HELP and the\nrecent CADENCE trial with sotatercept (274-285 meters) demonstrated an\napproximate 20-meter placebo-adjusted improvement in 6MWD. The overall trial\npopulation in LEVEL, however, had a median about 50-60 meters higher than in\nthese previous PH-HFpEF trials.\n* Prognostic implications include the impact of levosimendan on NT-proBNP\ncompared to multiple classes of heart failure therapies, including some\ncurrently being tested, with commentary of the magnitude of effect in relation\nto heart failure events. As noted in the presentation, no data from a Phase 3\nrandomized trial has demonstrated even half the impact on this key indicator\nof cardiac wall stress, when compared to placebo. In an analysis of the\nrelationship between heart failure outcomes and NT-proBNP change across these\nclasses, Dr. Shah noted that the magnitude of levosimendan’s effect on\ncardiac wall stress suggests potential impact on outcomes in these HFpEF\npatients.\n* In addition to RVSP, many echocardiographic endpoints show improvement with\nlevosimendan compared to placebo. Across each domain of echocardiography,\napproximately 20 echocardiographic parameters improved, even when adjusting\nfor multiple comparisons.\nDr. Shah referenced these results in the prespecified subgroup of patients\nwith a baseline 6MWD below the trial median of 333 meters (n = 119), at Week\n12:\n* 6MWD: least-squares mean change was +23.7 meters on TNX-103 versus −2.6\nmeters on placebo; treatment difference of +26.3 meters (p = 0.0112).\n* KCCQ-TSS: change was +9.8 points on TNX-103 versus +4.1 points on placebo; a\n5-point threshold is generally considered clinically meaningful.\n* RVSP: change of −4.4 mmHg on TNX-103 versus +0.5 mmHg on placebo;\ntreatment difference −4.9 mmHg (p = 0.009). (post-hoc analysis)\n* NT-proBNP: geometric least-squares mean ratio of 0.53 from baseline on\nTNX-103 (p < 0.0001), corresponding to a 47% reduction compared to placebo.\n(post-hoc analysis)\nThe Company intends that the LEVEL-2 population be enriched on the basis of\nclear evidence provided by the LEVEL results, and in a manner consistent with\nlongstanding FDA guidance for sponsors. Tenax will continue to focus on the\nglobal development of this product for patients with high unmet need.\n\nAbout Levosimendan (TNX-101, TNX-102, TNX-103)\n\nLevosimendan is a novel, first-in-class K-ATP channel activator/calcium\nsensitizer currently being evaluated to treat pulmonary hypertension (PH)\nassociated with heart failure with preserved ejection fraction (PH-HFpEF).\nLevosimendan was first developed for intravenous use in hospitalized patients\nwith acutely decompensated heart failure, and it has received market\nauthorization in 60 countries in this indication, although it is not available\nin the United States or Canada. Tenax’s Phase 2 HELP study, including its\nopen-label extension stage, demonstrated the potential of IV (TNX-101) and\noral (TNX-103) levosimendan to bring durable improvements in exercise capacity\nand quality of life, as well as other clinical assessments, in patients with\nPH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2,\na Phase 3, double-blind, randomized, placebo-controlled clinical trial in\npatients with PH-HFpEF.\n\nAbout Tenax Therapeutics\n\nTenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical\ncompany using clinical insights to develop novel cardiopulmonary therapies.\nThe Company owns global rights to develop and commercialize levosimendan,\nwhich it is developing for the treatment of PH-HFpEF, the most prevalent form\nof pulmonary hypertension globally, for which no product has been approved to\ndate. For more information, visit www.tenaxthera.com. Tenax Therapeutics’\ncommon stock is listed on The Nasdaq Stock Market LLC under the symbol\n“TENX”.\n\nCaution Regarding Forward-Looking Statements\n\nExcept for historical information, all of the statements, expectations and\nassumptions contained in this press release are forward-looking statements.\nThese forward-looking statements may include information concerning our\nclinical data, our regulatory plans, our future trial designs, and our\npossible or projected future business operations. Actual results might differ\nmaterially from those explicit or implicit in the forward-looking statements.\nImportant factors that could cause actual results to differ materially\ninclude: risks of our clinical trials, including, but not limited to, the\nresults of such trials, and the design, timing, delays, costs, location,\ninitiation, and enrollment of any future trials; any delays in regulatory\nreview and approval of product candidates in development; risks regarding the\nformulation, production, marketing, customer acceptance and clinical utility\nof our product candidates;   risks related to our business strategy,\nincluding the prioritization and development of product candidates; reliance\non third parties, including Orion Corporation, our manufacturers and CROs; our\nestimates regarding the potential market opportunity for our product\ncandidates; cash usage and runway may not be within management’s expected\nranges; the potential advantages of our product candidates; our competitive\nposition; our ability to maintain our culture and recruit, integrate and\nretain qualified personnel and advisors, including our executives and members\nof our Board of Directors; risks associated with our cash needs; intellectual\nproperty risks; volatility and uncertainty in the global economy and financial\nmarkets in light of unexpected changes in tariffs and the possibility of\npandemics, global financial and geopolitical uncertainties, including in the\nMiddle East and the Russian invasion of and war against the country of\nUkraine; changes in legal, regulatory and legislative environments in the\nmarkets in which we operate, and the impact of these changes on our ability to\nobtain regulatory approval for our products; and other risks and uncertainties\nset forth from time to time in our SEC filings. Tenax Therapeutics assumes no\nobligation and does not intend to update these forward-looking statements\nexcept as required by law.\n\nContact:\n\nInvestor and Media:\nArgot Partners\ntenax@argotpartners.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d8c1d3b1-51a5-4835-a9e8-6d5bce14917e)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX7GQ2s3","title":"Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026","author":"Globe Newswire","ticker":"TENX","created":"2026-08-29T12:21:22.090Z","tickers":["TENX"],"exchange":"NASDAQ","article_body":"In patients with a baseline 6MWD below the trial median of 333 meters,\ntreatment with TNX-103 resulted in a 26.3-meter improvement compared to\nplacebo (p = 0.0112)\n\nIn the same patient population, TNX-103 produced a 47% reduction in NT-proBNP\n(p < 0.0001) and a 4.9 mmHg reduction in RVSP (p = 0.009) compared to placebo\n\nWith full statistics analysis now complete, Company confirms TNX-103’s\nbiological effects include marked reductions in pulmonary artery pressure and\nNT-proBNP, a biomarker reflecting increased cardiac wall stress. Results will\ninform protocol population enrichment and changes to overall registrational\npath\n\nCHAPEL HILL, N.C., Aug. 29, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc.\n(Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”)\ntoday announced that additional results from the Phase 3 LEVEL clinical trial\nevaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension\ndue to heart failure with preserved ejection fraction (PH-HFpEF) were\npresented in a Late-Breaking Clinical Science session at the European Society\nof Cardiology (ESC) Congress 2026 in Munich, Germany.\n\nData confirmed findings from prespecified analyses which identified a\nfavorable treatment effect in patients with a lower baseline 6MWD, supported\nby consistent changes in prespecified endpoints measuring cardiac stress and\npulmonary pressures.\n\n“The independent analysis of LEVEL data we presented today sharpens what the\nearlier topline results initially indicated: patients with the lowest baseline\nwalking distance had the greatest improvement, on top of state-of-the-art\nbackground therapy. What was particularly striking was that even patients who\ndid not show a significant improvement in exercise capacity had the same\nmagnitude of reduction in cardiac wall stress and pulmonary artery pressures,\nchanges that correspond to a reduction in heart failure hospitalizations over\nlonger follow-up,” said Sanjiv Shah, MD, Director of the HFpEF Program at\nNorthwestern University Feinberg School of Medicine and LEVEL’s Principal\nInvestigator. “The magnitude of the reduction in NT-proBNP and the\naccompanying lowering of pulmonary pressure indicate that TNX-103 may provide\nclinical benefit to the majority of patients with PH-HFpEF independent of its\neffect on walk distance. The data are compelling and consistently point toward\na potential therapeutic benefit in PH-HFpEF patients.”\n\n“The full set of prespecified analyses we completed in the last week, and\nDr. Shah’s presentation of the results today, continue to emphasize that the\ntreatment effect of TNX-103 is concentrated in patients walking less than the\ntrial median of 333 meters at baseline. The finding of biologic efficacy in\nthe majority of patients in LEVEL validates that the unique mechanism of\naction demonstrated in the Phase 2 HELP study can address patient function.\nThat gives us conviction and a clear strategy to enrich LEVEL-2 for a study\npopulation of patients in whom the treatment effect is demonstrable,” said\nStuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. “LEVEL has\nbeen enormously informative in shaping what comes next, and we intend to move\nquickly on behalf of patients who currently have no approved treatment\noptions.”\n\nKey Takeaways from Late-Breaking Presentation\n\nThe Phase 3 LEVEL clinical trial (NCT05983250) randomized 241 patients with\nPH-HFpEF across 41 sites in the United States and Canada. In this population,\nthe primary endpoint of change in 6-minute walk distance (6MWD) at Week 12 did\nnot achieve statistical significance, nor did the key secondary endpoint,\nchange in Kansas City Cardiomyopathy Questionnaire total symptom score\n(KCCQ-TSS); however, marked improvements were noted in exploratory endpoints\nthat demonstrate the biologic effects of the therapy, notably N-terminal\npro-B-type natriuretic peptide (NT-proBNP) and right ventricular systolic\npressure (RVSP).\n\nSeveral key observations made in the trial, and their potential influence on\nthe future development of levosimendan for patients with pulmonary\nhypertension and heart failure, were emphasized:\n* Across the overall trial population (n = 241), TNX-103 was safe and well\ntolerated, with no significant arrhythmias.\n* This population of older, symptomatic patients presented with multiple\ncomorbidities, and was well-treated on guideline-directed medical therapy\n(GDMT): across these categories of increasing disease severity, with emphasis\nplaced on atrial fibrillation and exercise tolerance, and increasing\ntherapeutic intervention like MRAs/diuretics, and SGLT-2 inhibitors,\nlevosimendan’s benefit appears to increase.\n* An inverse linear relationship between baseline 6MWD and treatment effect\nwas described and demonstrated not to be explained by regression to the mean.\nPatients in LEVEL whose baseline 6MWD match those reported in HELP and the\nrecent CADENCE trial with sotatercept (274-285 meters) demonstrated an\napproximate 20-meter placebo-adjusted improvement in 6MWD. The overall trial\npopulation in LEVEL, however, had a median about 50-60 meters higher than in\nthese previous PH-HFpEF trials.\n* Prognostic implications include the impact of levosimendan on NT-proBNP\ncompared to multiple classes of heart failure therapies, including some\ncurrently being tested, with commentary of the magnitude of effect in relation\nto heart failure events. As noted in the presentation, no data from a Phase 3\nrandomized trial has demonstrated even half the impact on this key indicator\nof cardiac wall stress, when compared to placebo. In an analysis of the\nrelationship between heart failure outcomes and NT-proBNP change across these\nclasses, Dr. Shah noted that the magnitude of levosimendan’s effect on\ncardiac wall stress suggests potential impact on outcomes in these HFpEF\npatients.\n* In addition to RVSP, many echocardiographic endpoints show improvement with\nlevosimendan compared to placebo. Across each domain of echocardiography,\napproximately 20 echocardiographic parameters improved, even when adjusting\nfor multiple comparisons.\nDr. Shah referenced these results in the prespecified subgroup of patients\nwith a baseline 6MWD below the trial median of 333 meters (n = 119), at Week\n12:\n* 6MWD: least-squares mean change was +23.7 meters on TNX-103 versus −2.6\nmeters on placebo; treatment difference of +26.3 meters (p = 0.0112).\n* KCCQ-TSS: change was +9.8 points on TNX-103 versus +4.1 points on placebo; a\n5-point threshold is generally considered clinically meaningful.\n* RVSP: change of −4.4 mmHg on TNX-103 versus +0.5 mmHg on placebo;\ntreatment difference −4.9 mmHg (p = 0.009). (post-hoc analysis)\n* NT-proBNP: geometric least-squares mean ratio of 0.53 from baseline on\nTNX-103 (p < 0.0001), corresponding to a 47% reduction compared to placebo.\n(post-hoc analysis)\nThe Company intends that the LEVEL-2 population be enriched on the basis of\nclear evidence provided by the LEVEL results, and in a manner consistent with\nlongstanding FDA guidance for sponsors. Tenax will continue to focus on the\nglobal development of this product for patients with high unmet need.\n\nAbout Levosimendan (TNX-101, TNX-102, TNX-103)\n\nLevosimendan is a novel, first-in-class K-ATP channel activator/calcium\nsensitizer currently being evaluated to treat pulmonary hypertension (PH)\nassociated with heart failure with preserved ejection fraction (PH-HFpEF).\nLevosimendan was first developed for intravenous use in hospitalized patients\nwith acutely decompensated heart failure, and it has received market\nauthorization in 60 countries in this indication, although it is not available\nin the United States or Canada. Tenax’s Phase 2 HELP study, including its\nopen-label extension stage, demonstrated the potential of IV (TNX-101) and\noral (TNX-103) levosimendan to bring durable improvements in exercise capacity\nand quality of life, as well as other clinical assessments, in patients with\nPH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2,\na Phase 3, double-blind, randomized, placebo-controlled clinical trial in\npatients with PH-HFpEF.\n\nAbout Tenax Therapeutics\n\nTenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical\ncompany using clinical insights to develop novel cardiopulmonary therapies.\nThe Company owns global rights to develop and commercialize levosimendan,\nwhich it is developing for the treatment of PH-HFpEF, the most prevalent form\nof pulmonary hypertension globally, for which no product has been approved to\ndate. For more information, visit www.tenaxthera.com. Tenax Therapeutics’\ncommon stock is listed on The Nasdaq Stock Market LLC under the symbol\n“TENX”.\n\nCaution Regarding Forward-Looking Statements\n\nExcept for historical information, all of the statements, expectations and\nassumptions contained in this press release are forward-looking statements.\nThese forward-looking statements may include information concerning our\nclinical data, our regulatory plans, our future trial designs, and our\npossible or projected future business operations. Actual results might differ\nmaterially from those explicit or implicit in the forward-looking statements.\nImportant factors that could cause actual results to differ materially\ninclude: risks of our clinical trials, including, but not limited to, the\nresults of such trials, and the design, timing, delays, costs, location,\ninitiation, and enrollment of any future trials; any delays in regulatory\nreview and approval of product candidates in development; risks regarding the\nformulation, production, marketing, customer acceptance and clinical utility\nof our product candidates;   risks related to our business strategy,\nincluding the prioritization and development of product candidates; reliance\non third parties, including Orion Corporation, our manufacturers and CROs; our\nestimates regarding the potential market opportunity for our product\ncandidates; cash usage and runway may not be within management’s expected\nranges; the potential advantages of our product candidates; our competitive\nposition; our ability to maintain our culture and recruit, integrate and\nretain qualified personnel and advisors, including our executives and members\nof our Board of Directors; risks associated with our cash needs; intellectual\nproperty risks; volatility and uncertainty in the global economy and financial\nmarkets in light of unexpected changes in tariffs and the possibility of\npandemics, global financial and geopolitical uncertainties, including in the\nMiddle East and the Russian invasion of and war against the country of\nUkraine; changes in legal, regulatory and legislative environments in the\nmarkets in which we operate, and the impact of these changes on our ability to\nobtain regulatory approval for our products; and other risks and uncertainties\nset forth from time to time in our SEC filings. Tenax Therapeutics assumes no\nobligation and does not intend to update these forward-looking statements\nexcept as required by law.\n\nContact:\n\nInvestor and Media:\nArgot Partners\ntenax@argotpartners.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d8c1d3b1-51a5-4835-a9e8-6d5bce14917e)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-29T12:21:22.139881723Z","server_sent_at_ms":1788006082139},"received_at":"2026-08-29T12:21:22.320Z","source_url":null},"analysis":{"id":"119609","press_release_id":"130699","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Primary endpoint of 6MWD did not achieve statistical significance in the overall trial population","Key secondary endpoint of KCCQ-TSS did not achieve statistical significance in overall population"],"eventType":"clinical_trial","narrative":"Tenax Therapeutics presented data from the Phase 3 LEVEL trial of TNX-103 in PH-HFpEF patients at the ESC Congress, revealing a statistically insignificant result on the primary endpoint in the overall population.\n\nHowever, prespecified subgroup analyses identified patients with a baseline 6-minute walk distance below 333 meters who experienced significant benefits, including a 26.3-meter improvement in walk distance and a 47% reduction in NT-proBNP.\n\nThe biomarker and echocardiographic data also demonstrated marked reductions in cardiac wall stress and pulmonary artery pressure in this subgroup.\n\nBased on these findings, the company plans to enrich the population for the upcoming LEVEL-2 trial to focus on patients with lower baseline exercise capacity.","sentiment":"mixed","agentHooks":{"shouldPost":true,"suggestedAngle":"Phase 3 primary endpoint miss salvaged by robust subgroup efficacy; company pivots strategy to enrich next trial."},"keyFigures":{"drugName":"TNX-103 (oral levosimendan)","phaseOfTrial":"Phase 3","customDimensions":{"subgroup_patients":119,"p_value_6mwd_subgroup":0.0112,"p_value_rvsp_subgroup":0.009,"overall_trial_patients":241,"baseline_6mwd_cutoff_meters":333,"p_value_nt_pro_bnp_subgroup":"< 0.0001","subgroup_rvsp_reduction_mmhg":4.9,"subgroup_6mwd_improvement_meters":26.3,"subgroup_kccq_improvement_points":9.8,"subgroup_nt_pro_bnp_reduction_percent":47}},"quotedText":"The magnitude of the reduction in NT-proBNP and the accompanying lowering of pulmonary pressure indicate that TNX-103 may provide clinical benefit to the majority of patients with PH-HFpEF independent of its effect on walk distance.","namedEntities":{"people":[{"name":"Sanjiv Shah","role":"Principal Investigator"},{"name":"Stuart Rich","role":"Chief Medical Officer"}],"products":["TNX-103","TNX-101","TNX-102","levosimendan"],"companies":[{"name":"Tenax Therapeutics, Inc.","ticker":"TENX"},{"name":"Northwestern University Feinberg School of Medicine","relationship":"research partner"},{"name":"European Society of Cardiology","relationship":"conference host"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Phase 3 LEVEL trial results showed a missed primary endpoint in the overall population, a typically negative event for a development-stage biotech. However, strong, statistically significant efficacy signals in a prespecified subgroup (lower baseline 6MWD) and biomarker validation (NT-proBNP) provide a clear path forward for the LEVEL-2 trial, sustaining the company's development thesis."},"tickerRelevance":{"others":[],"primary":"TENX"},"globalImportance":35,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small_cap_biotech","eventGravity":"mixed_phase_3_results","sectorWeight":"health_care"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"mixed","material_impact_score":4,"narrative":"Tenax Therapeutics presented data from the Phase 3 LEVEL trial of TNX-103 in PH-HFpEF patients at the ESC Congress, revealing a statistically insignificant result on the primary endpoint in the overall population.\n\nHowever, prespecified subgroup analyses identified patients with a baseline 6-minute walk distance below 333 meters who experienced significant benefits, including a 26.3-meter improvement in walk distance and a 47% reduction in NT-proBNP.\n\nThe biomarker and echocardiographic data also demonstrated marked reductions in cardiac wall stress and pulmonary artery pressure in this subgroup.\n\nBased on these findings, the company plans to enrich the population for the upcoming LEVEL-2 trial to focus on patients with lower baseline exercise capacity.","key_figures":{"drugName":"TNX-103 (oral levosimendan)","phaseOfTrial":"Phase 3","customDimensions":{"subgroup_patients":119,"p_value_6mwd_subgroup":0.0112,"p_value_rvsp_subgroup":0.009,"overall_trial_patients":241,"baseline_6mwd_cutoff_meters":333,"p_value_nt_pro_bnp_subgroup":"< 0.0001","subgroup_rvsp_reduction_mmhg":4.9,"subgroup_6mwd_improvement_meters":26.3,"subgroup_kccq_improvement_points":9.8,"subgroup_nt_pro_bnp_reduction_percent":47}},"named_entities":{"people":[{"name":"Sanjiv Shah","role":"Principal Investigator"},{"name":"Stuart Rich","role":"Chief Medical Officer"}],"products":["TNX-103","TNX-101","TNX-102","levosimendan"],"companies":[{"name":"Tenax Therapeutics, Inc.","ticker":"TENX"},{"name":"Northwestern University Feinberg School of Medicine","relationship":"research partner"},{"name":"European Society of Cardiology","relationship":"conference host"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-29T12:23:07.683Z","global_importance":35,"audience_relevance":30,"importance_components":{"tickerTier":"small_cap_biotech","eventGravity":"mixed_phase_3_results","sectorWeight":"health_care"}},"durationMs":105351,"modelName":"glm-4.7"}}