Tenax Therapeutics (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases, announced a major clinical milestone in its Phase 3 LEVEL trial.
The company has successfully randomized 230 patients in the study, which is evaluating TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).
The completion of this enrollment phase keeps Tenax on track to release highly anticipated topline results in the third quarter of 2026.
PH-HFpEF represents a significant unmet medical need, as there are currently no FDA-approved therapies specifically indicated for this condition.
To further bolster its clinical footprint, the company has also initiated the global Phase 3 LEVEL-2 study and opened an Open-Label Extension (OLE) study to gather long-term safety and efficacy data.
On the intellectual property front, the USPTO recently issued a Notice of Allowance for a patent covering Tenax’s subcutaneous formulations of levosimendan.
This expands the company’s potential delivery methods beyond oral and intravenous routes, strengthening its long-term competitive position in the heart failure market.
Financially, Tenax reported a net loss of $52.6 million for the full year 2025, compared to a loss of $17.6 million in 2024.
The wider loss was driven by a material increase in R&D and G&A expenses associated with the simultaneous execution of multiple Phase 3 programs.