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 (levosimendan): Type C meeting with FDA to discuss overall development and pathway to regulatory approval (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TNX-103 (levosimendan) — Type C meeting with FDA to discuss overall development and pathway to regulatory approval (Q1 2027). 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) | PH-HFpEF | small molecule | Phase 3 |
| Imatinib | Pulmonary arterial hypertension (PAH) | small molecule | Phase 3 |
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
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.