Shares of Tenax Therapeutics rose 9.85% to $2.175 on September 9, 2026, after the biotech company disclosed its Phase 3 LEVEL trial missed its primary endpoint but generated favorable secondary data, and laid out a more targeted approach for its follow-up study.
Tenax presented the results at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Day One. The company was unblinded for a short window prior to August 10, and the full data package was released publicly roughly 30 minutes before the conference presentation.
The LEVEL trial enrolled 480 patients across 15 to 16 countries in patients with heart failure with preserved ejection fraction and Group 2 pulmonary hypertension. It was the first Phase 3 study in Group 2 pulmonary hypertension to complete enrollment. The 12-week trial used the 6-minute walk test as its primary endpoint and recorded a least-squares mean treatment difference of 8 meters between levosimendan and placebo — not meeting statistical significance.
Median baseline walk distance was 333 meters, and approximately 75% of patients exceeded that threshold at screening. A previous ceiling used in the trial had been 450 meters. Patients below the median baseline walked 26 to 29 meters farther with levosimendan. Those in the same subgroup also using SGLT2 inhibitors achieved an additional 10 meters, totaling 36 meters of improvement. About 60% of the study population was on mineralocorticoid receptor antagonists.
On biomarkers, levosimendan reduced NT-proBNP by roughly 50% versus placebo. Right ventricular systolic pressure fell by about 5 mm Hg in patients below the median baseline walk, with a p-value of 0.009. Echocardiogram analysis covering 25 to 30 parameters showed 23 to 25 moving in a statistically significant, favorable direction, with only two reaching no significance. Clinical worsening did not differ between groups, and KCCQ quality-of-life scores showed only small, non-significant changes.
At the European Society of Cardiology late-breaker presentation two weeks earlier, data on NT-proBNP levels as low as 40 to 50 pg/mL were disclosed.
Tenax plans to narrow enrollment for the LEVEL-2 trial, likely excluding patients who walk more than about 350 to 375 meters at baseline, a move expected to cut the eligible patient pool by roughly half.
The stock had fallen 84% year-to-date and traded near its 52-week low of $1.31 prior to the rally, though it remained about 51% above that level. The company holds more cash than debt with a current ratio of 15.07, and four analysts revised earnings estimates upward for the upcoming period.
