Orion Oyj B

Orion Corporation's license partner Tenax Therapeutics announced that the Phase 3 LEVEL trial of oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo. The key secondary endpoint of improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score was also not met. Prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration to discuss revisions to the ongoing registrational development of levosimendan for PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency.