Heart failure drug from Tenax Therapeutics fails in pivotal study

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

Tenax Therapeutics reported negative results Monday from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.

Shares of the biotech company plunged 84% to $2 in early trading. 

In the Phase 3 study called LEVEL, Tenax’s drug, an oral formulation of levosimendan, improved exercise capacity by 14 meters on a six-minute walking test compared to an improvement of 10.4 meters for a placebo. The difference was not statistically significant, failing to achieve the study’s primary efficacy goal, the company said.