Tenax Therapeutics, Inc. TENX
Tenax Therapeutics, Inc. (Nasdaq: TENX) is a cardio-renal-metabolic drug developer. Its lead program, TNX-103 (oral levosimendan), is in Phase 3 for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). Its next catalyst on record is TNX-103 LEVEL: Public release of 12-week randomized treatment period results (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TNX-103 LEVEL — Public release of 12-week randomized treatment period results (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TNX-103 oral levosimendan - LEVEL | PH-HFpEF | small molecule | Phase 3 |
| TNX-103 oral levosimendan - LEVEL-2 | PH-HFpEF | small molecule | Phase 3 |
| TNX-201 (modified-release imatinib) | pulmonary arterial hypertension | small molecule | Phase 1 |
| TNX-102 (subcutaneous levosimendan) | PH-HFpEF | small molecule | Pre-clinical |
Recent results and decisions
- Aug 10, 2026missed Phase 3 LEVEL missed primary endpoint: Week 12 6MWD difference 3.5 m vs placebo (p=0.63) and no KCCQ-TSS difference; subgroup baseline 6MWD <333 m showed +26.3 m (nominal p=0.0112) and NT-proBNP fell 49%.
LEVEL did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score.
Filing - Mar 10, 2026completed enrollment Achieved randomization target of 230 patients in Phase 3 LEVEL; screening closed, remaining screened patients may still qualify.
We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study.
Filing - Dec 17, 2025started Initiated global Phase 3 LEVEL-2 trial of TNX-103 in PH-HFpEF, planning ~540 patients randomized 2:1 with 6MWD at Week 26 as primary endpoint.
The Company also announced today that it has initiated LEVEL-2, the second registrational study of TNX-103 in patients with PH-HFpEF.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.