Tenax reports U.S. Phase 3 results for oral levosimendan; injectable approved in Europe

Tenax Therapeutics will soon report Phase 3 results for oral levosimendan in PH-HFpEF, a potential binary event that could double the stock or sink it to cash levels. LEVEL, a Phase 3 trial, tests oral levosimendan versus placebo for PH-HFpEF, a disease with no approved drugs. Its primary endpoint is six-minute walk distance; a benefit of about 15 meters should be statistically significant. Prior Phase 2 data were mixed: an intravenous version showed a walk improvement over placebo but did not affect heart pressure. An injectable levosimendan is approved in Europe; analysts estimate billions in potential U.S. sales.