TNX-103 (oral levosimendan) is a Tenax Therapeutics, Inc. program. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Tenax Therapeutics, Inc. (TENX). Review status: Phase 3 LEVEL did not meet its primary endpoint: patients walked 3.5 metres further than placebo at Week 12 (p=0.63), a difference small enough to be chance; the key secondary (KCCQ-TSS) was also not met. A prespecified subgroup with baseline 6MWD under 333 m improved 26.3 m (nominal p=0.0112) and NT-proBNP fell 49% versus placebo (nominal p<0.0001), but the company states: 'Nominal p-values are not adjusted for multiplicity and these analyses do not establish efficacy.' Tenax intends to request a Type C meeting with FDA. Full results were a Late-Breaking Clinical Science presentation at ESC Congress 2026 (Munich, Aug 28-31). Note: LEVEL-2 is a separate, still-running Phase 3 of the same drug (enrollment completing end of 2027) -- this row previously mis-named the trial. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 1,700,000 | $24.7 million | filed August 14, 2026 |
| RTW Investments | 696,570 | $10.1 million | filed August 14, 2026 |
| BVF Inc. | 339,549 | $4.9 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
TNX-103 (oral levosimendan)'s most recent tracked catalyst has already reported: primary endpoint not met data on Aug 10, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for TNX-103 (oral levosimendan) is in our archive yet.
Tenax Therapeutics, Inc. (TENX).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.