SQUAWK/NEWS
Account
Theme
Account
Menu
Live News EQUITY FLASH L impact

TENX As previously announced, Tenax Therapeutics, Inc. (the "Company") is enriching its LEVEL-2 clinical trial based on key learnings from i

TENX As previously announced, Tenax Therapeutics, Inc. (the "Company") 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 Company intends to amend LEVEL-2 enrollment criteria, as set forth in the attached Investor Presentation. To maximize the enrollment of these patients, whom LEVEL results suggest are those most likely to demonstrate improved exercise tolerance in the primary endpoint of LEVEL-2, the Company has temporarily paused enrollment in LEVEL-2. Enrollment may resume at each site as the amended protocol goes into effect there. The Company has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The Company's corporate presentation, which it intends to use with investors and analysts, has been updated to address these matters and is attached hereto as Exhibit 99.1 and incorporated herein by reference.