Tenax says Phase 3 LEVEL trial of TNX-103 in PH-HFpEF misses primary endpoint on 6-minute walk distance
TENX•Phase 3 LEVEL trial misses primary endpoint
Tenax Therapeutics reported topline Phase 3 LEVEL results for TNX-103 in PH-HFpEF; full data will be presented at ESC Congress 2026.
The trial missed its main efficacy goal in the overall study population, weakening the near-term regulatory case.
Prespecified analyses pointed to benefit in sicker patients, supporting a narrower target population and a potential revised path to approval.
Exploratory findings indicated favorable effects on cardiac stress and pulmonary pressure signals, despite the primary miss.
Tenax plans an FDA Type C meeting to discuss changes to the registrational program and an enrichment strategy for future studies.
