Key Takeaways:
Tenax Therapeutics shares fell roughly 85 percent after its Phase 3 LEVEL trial of TNX-103 missed primary and key secondary endpoints in PH-HFpEF patients.
"We believe the data from LEVEL provide new information that will guide us toward approval. Our mission is to bring the first approved therapy to patients with PH-HFpEF," Chris Giordano, president and CEO of Tenax Therapeutics, said.
The 241-patient trial evaluated whether levosimendan (TNX-103), an oral formulation of a calcium sensitizer, could improve how far patients could walk in six minutes after 12 weeks of treatment. PH-HFpEF is a condition in which pressure in the blood vessels of the lungs increases while the heart has difficulty filling properly. Patients receiving the drug improved their six-minute walk distance by 14 meters versus 10.4 meters for placebo — a 3.5-meter difference that was not statistically significant, meaning the study did not show convincing evidence the improvement was caused by the drug. TNX-103 also failed to significantly improve the Kansas City Cardiomyopathy Questionnaire symptom score, a key measure of heart failure symptoms.
Exploratory results showed a 49 percent greater reduction in NT-proBNP, a biomarker that rises when the heart is under stress, compared with placebo. The drug also reduced right ventricular systolic pressure by 3.5 mmHg versus placebo. Patients who could initially walk less than 333 meters improved by 26.3 meters compared with placebo. Tenax said TNX-103 was generally well tolerated with no new safety signals.
Tenax is pre-revenue, and TNX-103 was its lead clinical program. The stock's collapse erases most of the company's clinical value proposition. Levi & Korsinsky has opened a securities investigation into whether Tenax adequately disclosed risks tied to the program before the LEVEL results were released. The firm is examining potential securities law violations on behalf of TENX investors who suffered losses, and shareholders who purchased shares and lost money are encouraged to have their losses reviewed at no cost.
Tenax plans to meet with the FDA to discuss the full results and potentially adjust future trials to focus on patients who showed a stronger response. The company will also seek guidance from European regulators. Topline LEVEL data had been guided to August 2026, after previously being guided to the third quarter of 2026.
The decline puts the stock at its lowest level on record, down 86 percent so far this year. Retail sentiment on Stocktwits turned "extremely bullish" from "bullish" over the past 24 hours, with message volumes up 1,350 percent, as some traders called the selloff an overreaction. One user said the reduction in NT-proBNP is potentially "much more interesting" than the walking data.
The failed trial leaves Tenax without a lead clinical program and raises questions about the company's path forward. Investors will watch for the FDA meeting outcome and any regulatory pathway decisions as the company's next catalysts.
This article is for informational purposes only and does not constitute investment advice.
