Tenax Therapeutics reported that its Phase 3 LEVEL trial for TNX-103 (oral levosimendan) failed to meet its primary endpoint. The study showed no statistically significant improvement in exercise capacity for patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The trial also missed its key secondary endpoint for symptom improvement.
Tenax Therapeutics shares plunged more than 85% following the announcement.
Tenax identified a beneficial treatment effect within a prespecified subgroup of patients with more severe disease. The company plans to meet with the FDA to discuss a potential regulatory path for TNX-103 based on this subgroup analysis.