ORN Orion

levosimendan · NCT07436689 registry update

countries: {'total_sites': 9, 'us_sites': 9} → {'total_sites': 10, 'us_sites': 10}

levosimendan · NCT07288398 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING; countries: {'total_sites': 141, 'us_sites': 46} → {'total_sites': 140, 'us_sites': 45}

Tenax presents Phase 3 LEVEL results at ESC Congress 2026

The company presented full prespecified analyses from the completed Phase 3 LEVEL trial at ESC 2026, confirming that TNX-103 produced statistically significant improvements in 6MWD, NT-proBNP, and RVSP in the subgroup with baseline 6MWD below 333 meters. These data will guide population enrichment and protocol changes for the planned LEVEL-2 registrational trial.

Tenax LEVEL Phase 3 misses primary 6MWD endpoint for TNX-103 in PH-HFpEF

LEVEL Phase 3 trial of oral levosimendan (TNX-103) in PH-HFpEF did not meet the primary endpoint of 6-minute walk distance improvement versus placebo. Prespecified subgroup analyses showed a statistically significant 26.3-meter benefit in patients with baseline 6MWD below the trial median of 333 meters, accompanied by a 49% reduction in NT-proBNP and a 3.5 mmHg reduction in right ventricular systolic pressure. Tenax plans to request a Type C meeting with the FDA to discuss an enrichment strategy for the registrational program.