other material
confidence high
sentiment positive
materiality 0.65
Tenax Therapeutics enrolls first patient in Phase 3 LEVEL study for TNX-103 in PH-HFpEF; topline data expected H2 2025
TENAX THERAPEUTICS, INC.
- First patient enrolled in Phase 3 LEVEL study of oral TNX-103 (levosimendan) for PH-HFpEF; 152-patient trial.
- Over 40 U.S. and Canadian sites agreed to participate, including Mayo, Harvard, Northwestern.
- Topline data forecast for second half of 2025.
- FDA does not require long-term CV outcomes trial, reducing cost and time to registration.
- Patent estate protects TNX-103 through at least 2040.