TENX stock fell after Tenax Therapeutics said its Phase 3 LEVEL trial of oral levosimendan in PH-HFpEF did not reach its primary endpoint. The result resets the near-term path for the drug program and pushes the next discussion toward regulators, not a filing.
10 August 2026 brought the key readout: the study did not reach its primary endpoint, which was improvement in the 6-minute walk distance versus placebo, and it also missed the key secondary endpoint of Kansas City Cardiomyopathy Questionnaire total symptom score. For investors, that means the lead efficacy case for the program no longer rests on the main trial objective.
Tuukka Hirvonen and Orion
14.05 EEST was when Orion Corporation issued the stock exchange release, naming Tuukka Hirvonen, Head of Investor Relations, as the contact person. That release described the news as inside information, and it put the development setback into the market record alongside Orion Pharma's 2025 net sales of EUR 1,890 million and its about 4,000 professionals worldwide.
Orion's license partner Tenax said oral levosimendan was generally safe and well tolerated. Serious adverse events and adjudicated clinical worsening events were balanced across treatment arms, which matters because the efficacy miss did not come with an offsetting safety problem that would have forced a different kind of decision.
LEVEL subgroup signals
Prespecified subgroup analyses found a substantial beneficial treatment effect in patients with greater disease burden, and the findings were supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. That leaves the program in a narrower position: the broad trial missed, but the signal was not uniform across every patient group.
Tenax now intends to request a Type C Meeting with the FDA to discuss revisions to the ongoing registrational development of levosimendan for PH-HFpEF, and it also plans parallel scientific consultation from the European Medicines Agency. The open issue is simple and commercial at the same time: what exact revisions regulators will be asked to consider for a program that missed its main efficacy bar but still showed subgroup and biomarker signals.
