Tenax LEVEL Trial Full Data: 49% NT-proBNP Cut and +26.3m 6MWD in Sicker Patients Reshape LEVEL-2
TENX sits 59% above its 52-week low of $1.31.
Summary
Tenax presented full Phase 3 LEVEL data showing a 49% NT-proBNP reduction and +26.3m 6MWD improvement in patients with baseline 6MWD below 333m, providing a clear enrichment strategy for the LEVEL-2 trial despite the missed primary endpoint.
Key Events · Product Development and Regulatory · TENX
-
Full LEVEL Data Presented
Comprehensive Phase 3 LEVEL results presented at Cantor Global Healthcare Conference on 2026-09-09, following topline disclosure on 2026-08-10.
-
Subgroup Efficacy Signal
Patients with baseline 6MWD <333m showed +26.3m improvement vs placebo (95% CI: 6.0-46.7; nominal p=0.0112), consistent with the Phase 2 HELP trial.
-
Biomarker and Hemodynamic Impact
NT-proBNP reduced 49% vs placebo (geometric LS mean ratio 0.51, p<0.0001) — the largest reduction in an HFpEF RCT to date; RVSP declined 3.5 mmHg (p=0.0045).
-
Safety Profile
Higher treatment-related AEs on TNX-103 (38.3% vs 17.4%), dose reductions (15.0% vs 4.1%), and discontinuations (8.3% vs 1.7%), driven by headache, palpitations, and hypotension.
Analysis · TENX · Life Sciences
The comprehensive LEVEL analysis gives Tenax a credible path forward after the August topline miss. The prespecified subgroup of patients with baseline 6MWD below 333 meters showed a +26.3-meter improvement versus placebo (nominal p=0.0112), and the 49% NT-proBNP reduction is the largest ever seen in an HFpEF randomized trial. Management is using these data to enrich the LEVEL-2 trial design, which materially de-risks the levosimendan program. The safety profile shows higher treatment-related adverse events (38.3% vs 17.4%) driven by headache, palpitations, and hypotension — a tolerability burden that will need to be managed in future trials.
How filings like this one have moved
In the 30 days to Sep 10, 2026, 35.8% of the 1864 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was 0.00%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, TENX was trading at $2.08 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $74.1M. The 52-week trading range was $1.31 to $19.40. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.