Tenax Therapeutics confirms LEVEL Phase 3 trial enrollment on track; initiates global LEVEL-2 study

TENAX THERAPEUTICS, INC.

Blinded Sample Size Re-estimation (BSSR) shows LEVEL is powered >90% to detect 25m change in 6MWD primary endpoint.
LEVEL enrollment completion reaffirmed for H1 2026; topline data expected in H2 2026.
Global Phase 3 LEVEL-2 study initiated targeting ~540 PH-HFpEF patients; enrollment completion estimated by end of 2027.
Company plans to launch a long-term open-label extension (OLE) study for continued access to TNX-103.
Results confirm standard deviation lower than assumed 55 meters, de-risking trial design.

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