Tenax Therapeutics: pauses enrollment in LEVEL-2 trial

What happened Tenax Therapeutics, Inc. filed an 8-K on Oct 8, 2026, reporting that it is enriching its LEVEL-2 clinical trial based on key learnings from its recently completed Phase 3 LEVEL trial of TNX-103 in PH-HFpEF. The filing states the company intends to amend LEVEL-2 enrollment criteria as set forth in the attached investor presentation and has temporarily paused enrollment in LEVEL-2. The company has requested a Type C meeting with the U.S. Food and Drug Administration. The updated corporate presentation is attached as Exhibit 99.1.

Key details

• The enrichment is based on results from the recently completed Phase 3 LEVEL trial of TNX-103 in PH-HFpEF.
• The company intends to amend LEVEL-2 enrollment criteria per the investor presentation dated Oct 8, 2026.
• Enrollment in LEVEL-2 is temporarily paused and "may resume at each site as the amended protocol goes into effect there."
• The company requested a Type C meeting with the U.S. Food and Drug Administration; Exhibit 99.1 (investor presentation) is attached to the filing.

Why it may matter

• Item 8.01 (Other events) was reported; that item covers events such as changes to clinical trial plans and regulatory interactions.
• Item 9.01 lists exhibits and includes the updated investor presentation as Exhibit 99.1 dated Oct 8, 2026.
• The filing does not show why the company acted.