Tenax Therapeutics Stock Collapses After Phase 3 Levosimendan Trial Misses Endpoints

Overview

• The LEVEL Phase 3 trial of oral levosimendan (TNX-103) failed to meet its primary endpoint of 6‑minute walk distance and its key secondary Kansas City Cardiomyopathy Questionnaire symptom score, producing a least‑squares mean difference of 3.5 meters with p=0.63.
• Investors reacted sharply, sending Tenax shares down roughly 84% in pre‑market trading and wiping away the company’s pre‑readout market value that stood at about $503 million.
• Exploratory analyses showed possible benefits in specific measures, including a 49% fall in NT‑proBNP, a 3.5 mmHg reduction in right ventricular systolic pressure, and a 26.3‑meter 6MWD improvement in patients below the trial median, but those findings were not part of the prespecified primary analysis.
• Safety data were reported as generally acceptable and well tolerated across the study population, leaving a limited positive datapoint for future discussions with regulators.
• Tenax said it is preparing regulatory discussions and may seek a narrowed development or approval path focused on more severely affected PH‑HFpEF patients while its cash position, lack of revenue, and recent analyst optimism put near‑term strategy and valuation in flux.