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Tenax Therapeutics pauses LEVEL-2 enrollment to implement enrichment after Phase 3 LEVEL learnings
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Tenax Therapeutics temporarily paused LEVEL-2 enrollment to amend inclusion criteria and pursue FDA Type C feedback after Phase 3 LEVEL analyses showed benefit in sicker PH‑HFpEF patients. Key Highlights: LEVEL-2 enrollment paused temporarily to implement data-driven enrichment criteria from LEVEL trial analyses. Amended entry: 6MWD 100–300m OR 300–400m with RAVI ≥25 mL/m2 to target patients likeliest to benefit. LEVEL showed overall primary endpoint missed, but…