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Tenax endures (another) clinical catastrophe as its PhIII flops, shares blitzed

Another biotech day, another biotech microcap disaster.

Today’s turn goes to Tenax Therapeutics $TENX, a Morrisville, NC company which reported this morning that its Phase III study of its lead drug levosimendan “did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days.”

Tenax, with a market cap that started this morning at $54 million, still asserts that it may be able to blaze a path forward, focusing on two positive secondary endpoints for a “reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes.”

That would be a rare event, though. And investors weren’t going for the ride. The company’s stock was eviscerated, dropping 75% into penny stock territory.

This isn’t the first brush with disaster for Tenax. Formerly known as Oxygen Bio, the company had to endure a clinical hold on a drug aimed at speeding recovery for brain injuries, only to scrap the effort a little more than two years ago citing enrollment woes.

As Tenax, the company moved on to levosimendan, which it in-licensed for $5 million in company stock. The drug is marketed in 50 countries, outside the US.


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RAPS Regulatory Convergence 2017