Tenax Pauses LEVEL-2 Enrollment to Amend Protocol After LEVEL Data
TENX sits 41% above its 52-week low of $1.31.
Summary
Tenax paused LEVEL-2 enrollment to amend the protocol with enrichment criteria from LEVEL data, and requested an FDA Type C meeting to discuss levosimendan development.
Key Events · Product Development and Regulatory · TENX
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LEVEL-2 Enrollment Paused
Tenax temporarily paused screening and randomization in the Phase 3 LEVEL-2 trial to implement a protocol amendment enriching for patients most likely to respond to levosimendan.
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New Enrichment Criteria
Amended entry criteria: baseline 6MWD ≤300m, or 300–400m with RAVI ≥25 mL/m². In LEVEL, patients meeting these criteria showed >34m placebo-adjusted improvement (95% CI +15 to +53m; p=0.001).
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FDA Type C Meeting Requested
Tenax requested a Type C meeting with the FDA to discuss the overall development of levosimendan in PH-HFpEF, following sharing of topline LEVEL results in mid-August.
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Minimal Enrollment Impact
Company estimates less than 5% of LEVEL-2 patients in the primary efficacy analysis will have been enrolled without meeting the stricter amended criteria.
Analysis · TENX · Life Sciences
Tenax is temporarily pausing enrollment in its Phase 3 LEVEL-2 trial to implement a data-driven enrichment strategy based on the failed LEVEL trial. The amended criteria target patients with baseline 6MWD ≤300m, or 300–400m with RAVI ≥25 mL/m² — the subgroup that showed a +34m placebo-adjusted improvement in LEVEL. The company has requested a Type C meeting with the FDA to discuss the overall levosimendan development path. This is a pivotal operational decision: it signals management's confidence that the drug works in a narrower, sicker population, but it also delays the trial and adds execution risk. The pause is explicitly not safety-related and affects fewer than 5% of planned primary-analysis patients.
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At the time of this filing, TENX was trading at $1.85 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $69.6M. The 52-week trading range was $1.31 to $19.40. This filing was assessed with neutral market sentiment and an importance score of 7 out of 10.