other material
confidence high
sentiment neutral
materiality 0.60
Tenax prioritizes oral levosimendan Phase 3 for PH-HFpEF in 2023
TENAX THERAPEUTICS, INC.
- Company to initiate Phase 3 trial of TNX-103 (oral levosimendan) for PH-HFpEF in 2023.
- PH-HFpEF affects >1.6M North Americans; no FDA-approved therapy exists.
- Patent estate expanded; protection through at least 2040 with additional IP expected in 2023.
- FDA agreed Phase 3 endpoints: 6-minute walk distance at 12 weeks or clinical worsening at 24 weeks.
- Imatinib Phase 3 deferred beyond 2023 pending fundraising and strategic review.