FDA Approves Tenax’s Dual Phase 3 Trials Tenax Therapeutics has received FDA approval to expand its Phase 3 LEVEL program for TNX-103. Enrollment will increase from 152 to 230 patients, enhancing statistical power. A second global trial, LEVEL-2, will also launch in 2025. The trials aim to address PH-HFpEF, a condition with no approved treatments, by mid-2026.45