Tenax Therapeutics LEVEL Trial Shows Over 90% Power to Detect 25m Change
Tenax Therapeutics announced that the prespecified Blinded Sample Size Re-estimation of LEVEL demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance, the primary endpoint. Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026. LEVEL is an ongoing, registrational Phase 3 clinical trial evaluating TNX-103 in patients with pulmonary hypertension in heart failure with preserved ejection fraction in the United States and Canada. The prespecified, blinded review of the standard deviation in 6MWD change observed in the first 150 randomized, placebo-controlled patients, yielded a result of less than the assumed 55 meters. The Company also announced that it has initiated LEVEL-2, the second registrational study of TNX-103 in patients with PH-HFpEF. LEVEL-2 is a global, Phase 3, double-blind, randomized, placebo-controlled study of TNX-103. The clinical trial plans to enroll approximately 540 PH-HFpEF patients, randomized 2:1 to receive TNX-103 or placebo. The primary endpoint of the study is change from baseline in 6MWD at Week 26. Secondary endpoints include change from baseline in Kansas City Cardiomyopathy Questionnaire and New York Heart Association Functional Class. In addition, Tenax announced it will initiate a global, multi-center, long-term, open-label extension study. The OLE study will provide patients enrolled in levosimendan clinical trials continued access to TNX-103 after study completion and until potential availability of a commercialized product.
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Tenax Therapeutics (TENX) Price Target Raised by 12.22% to 25.76
Price Target Update: The average one-year price target for Tenax Therapeutics (NasdaqCM:TENX) has been revised to $25.76 per share, reflecting a 12.22% increase from the previous estimate of $22.95, with a potential range between $20.20 and $31.50 per share.
Fund Sentiment: There are currently 48 funds reporting positions in Tenax Therapeutics, marking a 20% increase in ownership over the last quarter, with total shares owned by institutions rising by 109.94% to 4,753K shares.
Significant Shareholder Activity: Ikarian Capital and Boothbay Fund Management both increased their holdings by 100%, while VR Adviser raised its stake by 77.48%, indicating strong interest from institutional investors.
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Tenax Initiates Global LEVEL-2 Study, Enrollment Expected by 2027
- Trial Design Confirmation: Tenax Therapeutics' LEVEL study underwent a Blinded Sample Size Re-estimation, demonstrating over 90% statistical power to detect a 25-meter change in 6-minute walk distance, which bolsters confidence in the company's drug development in heart failure.
- Enrollment Progress: The LEVEL study is expected to complete enrollment in the first half of 2026, indicating smooth clinical trial progress in cardiopulmonary therapies, allowing timely access to critical data to support further development.
- New Study Initiation: The LEVEL-2 study has been initiated, aiming to enroll approximately 540 patients, with completion expected by the end of 2027, which will provide crucial data to support the market potential of TNX-103.
- Long-term Study Plan: Tenax will also conduct a long-term open-label extension study to ensure participants continue receiving TNX-103 after trial completion, enhancing patient reliance on the company's product.
