Tenax Therapeutics Presents Additional Phase 3 LEVEL Data Showing TNX-103 Benefits in PH-HFpEF Patients With Lower Baseline Walk Distance

Tenax Therapeutics presented Phase 3 LEVEL trial results at ESC Congress 2026. TNX-103 showed significant improvements in patients with PH-HFpEF and baseline 6MWD below 333 meters, including a 26.3m walk distance improvement, 47% NT-proBNP reduction, and 4.9 mmHg RVSP reduction. The company plans to enrich the population for the next study.

Tenax Therapeutics (TENX) shares dropped 84-85% after its Phase 3 LEVEL trial for TNX-103 failed primary and key secondary endpoints. The company is pre-revenue, and TNX-103 was its lead program. Levi & Korsinsky is investigating potential securities law violations on behalf of affected investors.

Biotech stocks moved sharply after clinical and guidance updates. Tenax Therapeutics (TENX) fell nearly 90% after its Phase 3 LEVEL trial of TNX-103 missed primary and key secondary endpoints. AbCellera Biologics (ABCL) rose on Phase 2 results for ABCL635 in menopausal vasomotor symptoms. 10x Genomics (TXG) gained after raising full-year revenue guidance and citing strong early Atera demand.

Tenax Therapeutics (Nasdaq: TENX) shares fell about 90% to $1.38 after it reported Phase III LEVEL trial top-line results for TNX-103 (oral levosimendan) in PH-HFpEF. The trial did not meet the primary endpoint of improving 6-minute walk distance versus placebo, nor a key secondary endpoint on Kansas City Cardiomyopathy Questionnaire symptom score, according to the company.

Tenax reported its Phase III LEVEL trial of oral levosimendan missed the primary endpoint. The six-minute walk improvement versus placebo was 3.5 meters but not statistically significant, and the quality-of-life endpoint also failed. Subgroup and biomarker results suggested larger benefits in higher-risk patients. Tenax will consult the FDA and EMA and may adjust LEVEL-2 or run a new study.

US equity futures largely gave back overnight gains after oil hit a one-week high and the yen weakened. Traders await US CPI and PPI, with rate-hike bets cooling after Friday’s jobs report. JPMorgan raised its S&P 500 year-end target to 8000. Corporate movers include AAON (+8%), ABCL (+22%), HZO halted on a $53 buyout, and VREX surging on Teledyne’s $18.90 offer.