Market reactionShares fell 11% on Nov 5.
Tenax Therapeutics is developing TNX-103, oral levosimendan, for pulmonary hypertension caused by heart failure with preserved ejection fraction (PH-HFpEF); it is not approved.
Phase 3 LEVEL of TNX-103 missed its primary endpoint: walk distance improved 3.5 meters more than placebo (p=0.63). Patients who walked less than 333 meters at baseline improved 26.3 meters (nominal p=0.0112), and NT-proBNP fell 49%. Tenax paused LEVEL-2, its second Phase 3, to enrol patients with low walk distance, or moderate walk distance with an enlarged right atrium. It has requested an FDA Type C meeting. Cash of $118.0 million funds operations through the second quarter of 2028.
Thesis checklist
2 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA supports the amended LEVEL-2
Does FDA accept an enriched LEVEL-2 as a path to approval for TNX-103 in PH-HFpEF?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
LEVEL missed; Tenax amends LEVEL-2 to enrol sicker PH-HFpEF patients
LEVEL Phase 3 miss forces enriched-population retry; FDA Type C meeting will determine whether a subgroup rescue is registrationally viable
LEVEL Phase 3 randomization target achieved
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Lung and respiratory diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
7 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.