TENAX THERAPEUTICS, INC. 8K

Tenax Therapeutics announced that its Phase 3 LEVEL trial of oral levosimendan in PH-HFpEF failed to meet the primary endpoint in the overall population but showed meaningful efficacy signals and biomarker improvements in higher-burden patients, prompting plans to refine its development and regulatory strategy.

Tenax Therapeutics reported topline results from its Phase 3 LEVEL registrational trial of oral levosimendan (TNX-103) in PH-HFpEF, disclosing that while the study did not meet its primary endpoint of improving 6-minute walk distance in the overall population, the drug demonstrated a strong treatment effect and pronounced biomarker and hemodynamic benefits in patients with higher disease burden, evidenced by substantial NT‑proBNP reductions and RVSP improvements, along with a safety profile characterized as generally safe and well-tolerated despite higher rates of treatment-related adverse events versus placebo; based on these data, Tenax plans to modify its Phase 3 development strategy, cap baseline 6MWD for future enrollment, and seek regulatory feedback through an FDA Type C meeting and parallel EMA scientific consultation to guide potential regulatory pathways.

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0001193125-26-341236

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