Tenax Therapeutics presents LEVEL trial update; primary endpoint missed, LEVEL-2 planned
Tenax Therapeutics furnished an investor presentation at the Cantor Global Healthcare Conference on September 9, 2026, reviewing full results of its Phase 3 LEVEL trial of TNX-103 (oral levosimendan) in PH-HFpEF. The trial did not reach statistical significance on its primary endpoint, the change in 6-minute walk distance, which was a 3.5-meter treatment difference (p = 0.63). The company says the results will guide the design of its follow-on trial, LEVEL-2, and the presentation includes subgroup results for patients with baseline walk distance below the median.
Key points
- Primary endpoint, 6MWD change at week 12: 3.5 m treatment difference vs. placebo (p = 0.63); the company describes the trial as not meeting its primary endpoint.
- Overall population NT-proBNP fell 49% vs. placebo at week 12 (nominal p < 0.0001); RVSP fell 3.5 mmHg vs. placebo.
- Prespecified subgroup with baseline 6MWD below 333 m: +26.3 m treatment effect (95% CI 6.0 to 46.7; nominal p = 0.0112); these are subgroup results from a trial whose primary endpoint was not met.
- Adverse events were higher on TNX-103 (86.7% vs. 71.9% any adverse event); serious adverse events were 10.8% vs. 10.7%.
The filing
Written by AI on Nov 9, 2026, 8:51 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 09, 2026.
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