Orion License Partner Tenax's Pulmonary Hypertension Drug Fails to Improve Walk Distance in Late-stage Trial

09:29 AM EDT, 08/10/2026 (MT Newswires) -- Tenax Therapeutics' oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction missed its primary endpoint of improvement in the six-minute walk distance compared with placebo. Orion (ORNBV.HE) said Monday its license partner Tenax's phase 3 Level trial also showed that the drug did not reach the key secondary endpoint of improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score. As such, Tenax plans to seek a Type C meeting with the US Food and Drug Administration for potential changes to the drug's ongoing registrational development, while also seeking parallel scientific consultation from the European Medicines Agency.