regulatory
confidence high
sentiment positive
materiality 0.70
Tenax Therapeutics receives U.S. patent for oral levosimendan (TNX-103) in PH-HFpEF, expiring 2040
TENAX THERAPEUTICS, INC.
- USPTO granted Patent No. 11,701,355 for oral levosimendan (TNX-103) to treat PH-HFpEF, with exclusivity through December 2040.
- No FDA-approved treatments exist for PH-HFpEF, which affects over 1.6 million North Americans, projected to exceed 2 million by 2030.
- Phase 2 HELP study showed statistically significant improvement in 6-minute walk distance for levosimendan.
- Tenax intends to initiate a Phase 3 trial of TNX-103 in 2023, planning to demonstrate efficacy in this underserved patient population.
- Patent builds on existing IP for IV and subcutaneous levosimendan formulations for PH-HFpEF.