Why Did TENX Stock Crash 89% Today?

• The Phase 3 LEVEL trial enrolled 241 patients and evaluated whether TNX-103 could improve how far patients could walk in six minutes after 12 weeks of treatment.
• Patients receiving TNX-103 improved their six-minute walk distance by 14 meters, compared with 10.4 meters for placebo, which is not considered statistically significant.
• Tenax said it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the full results and potentially adjust future trials.

Shares of Tenax Therapeutics (TENX) crashed nearly 89% to a record low in early trading on Monday, after the biotech firm’s experimental drug TNX-103 failed to meet the main goal of a late-stage study in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction, or PH-HFpEF.

PH-HFpEF is a condition in which pressure in the blood vessels of the lungs increases while the heart has difficulty filling properly.

Phase 3 Trial Misses Primary And Secondary Goals

The Phase 3 LEVEL trial enrolled 241 patients and evaluated whether TNX-103, an oral form of Levosimendan, could improve how far patients could walk in six minutes after 12 weeks of treatment.

Patients receiving TNX-103 improved their six-minute walk distance by 14 meters, compared with 10.4 meters for placebo. The 3.5-meter difference was not statistically significant, meaning the study did not show convincing evidence that the improvement was caused by the drug.

TNX-103 also failed to significantly improve a key questionnaire measuring heart failure symptoms.

However, the trial also showed that patients who could initially walk less than 333 meters improved by 26.3 meters compared with placebo.

Why Management Remains Bullish

TNX-103 also produced a 49% 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, a measure of pressure on the right side of the heart, by 3.5 millimeters of mercury compared with placebo. Tenax said TNX-103 was generally well tolerated with no new safety signals.

Tenax said it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the full results and potentially adjust future trials to focus on patients who showed a stronger response to TNX-103. The company will also seek guidance from European regulators.

“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,” said Chris Giordano, President and CEO.

MLTX Traders Mixed On Phase 3 Data

Despite the sharp slump, retail sentiment surrounding TENX on Stocktwits turned ‘extremely bullish’ from ‘bullish’ over the past 24 hours, amid a 1,350% increase in message volumes.

One user called the selloff an “overreaction.”

Another user said the reduction in NT-proBNP is potentially “much more interesting” than the walking data.

The stock is down 86% so far this year.

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