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Later this month, Tenax Therapeutics will report results from a Phase 3 study evaluating an oral treatment for a type of heart failure associated with high blood pressure in the lungs. The study outcome might be one of the biggest binary stock events remaining on the biotech docket this year. Tenax’s stock price could double or more if the study hits, or sink to cash levels if it fails.
Adding to the fun is the crapshoot nature of the study readout. This is a complicated disease, the proposed mechanism by which Tenax’s drug might work is unproven, and data from a prior study were mixed. Lastly, Tenax’s entire future rests on this one drug and indication. It has no fallback plan.
Tenax declined an interview request.
The company’s Phase 3 LEVEL study is evaluating an oral formulation of levosimendan versus placebo in patients with pulmonary hypertension due to heart failure with preserved ejection fraction, or PH-HFpEF. It’s a chronic, progressive disease in which the heart pumps normally but muscles on the left side (where oxygenated blood is received and pumped to the rest of the body) are too stiff to fill properly. As a result, a backup of blood raises pressure in the lungs, further stressing the heart. Patients with PH-HFpEF experience shortness of breath when performing daily activities or exercise, fluid buildup, and fatigue. The disease can progress to heart failure.
