Tenax Therapeutics plunges 89.49% after Phase 3 TNX-103 trial misses endpoints

Tenax Therapeutics shares fell 89.49% to $1.79 after the Phase 3 LEVEL trial of oral levosimendan, or TNX-103, in PH-HFpEF missed both its primary endpoint and a key secondary endpoint, with a 3.5-meter placebo-corrected improvement in six-minute walk distance at 12 weeks and a p-value of 0.63. The company said prespecified subgroup analyses suggested stronger efficacy in sicker and older patients, including a nominal 26.3-meter gain in patients with baseline walk distances below 333 meters, alongside a 49% reduction in NT-proBNP and a nominally significant 3.5-millimeter-of-mercury improvement in right ventricular systolic pressure, even as adverse events and discontinuations were higher on active treatment. Tenax plans a Type C meeting with the U.S. Food and Drug Administration, consultation with the European Medicines Agency, and potential changes to its ongoing LEVEL-2 study or a new trial, while Johnson Fistel, PLLP has separately opened an investigation into whether the company adequately disclosed risks around LEVEL's design and enrolled population.

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