LEVEL Phase 3 miss forces enriched-population retry; FDA Type C meeting will determine whether a subgroup rescue is registrationally viable

Tenax Therapeutics is a clinical-stage company developing a heart-failure drug for pulmonary hypertension that is not yet approved.

TNX-103, a levosimendag formulation for pulmonary hypertension in heart failure with preserved ejection fraction, missed its Phase 3 primary endpoint decisively (3.5m walk improvement, p=0.63). The thesis now rests entirely on whether FDA accepts a population-enriched LEVEL-2 design built on a post-hoc subgroup, a regulatory path with no written agency endorsement yet. The core risk is that FDA declines to validate the enrichment strategy at the Type C meeting, stranding a running Phase 3 trial with no approvable endpoint.