regulatory
confidence high
sentiment positive
materiality 0.75
Tenax Therapeutics receives USPTO Notice of Allowance for oral levosimendan patent in PH-HFpEF
TENAX THERAPEUTICS, INC.
- Patent covers oral levosimendan (TNX-103) for PH-HFpEF; term through Dec 2040, possible extension beyond.
- No FDA-approved treatments exist for PH-HFpEF, affecting >1.6M North Americans, projected >2M by 2030.
- Phase 2 HELP study showed levosimendan improved 6-minute walk by 29 meters (p=0.03) vs placebo.
- Tenax intends to initiate Phase 3 trial of oral formulation in 2023; FDA agreed 6-minute walk test as primary endpoint.