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Tenax Therapeutics' heart failure pill misses primary goal in Phase 3 trial

Tenax Therapeutics announced that its oral levosimendan failed to show a statistically significant benefit in a late-stage study for pulmonary hypertension-related heart failure, sending its shares sharply lower.

The biotech disclosed that the Phase 3 LEVEL trial did not meet its primary efficacy endpoint, as the drug improved six-minute walk distance by 14 meters versus 10.4 meters for placebo, a difference that was not statistically significant. The negative outcome caused Tenax's stock to tumble about 84% to $2 in early trading. The study evaluated an oral formulation of levosimendan for patients with heart failure linked to high lung blood pressure.

Why it matters

The failure delays a potential new therapy and triggers a steep stock drop, affecting investors and patients awaiting treatment.

In this story

heart failurelevosimendanPhase 3LEVEL studysix-minute walk teststock plungebiotechpulmonary hypertension