Phase 3 Trial Failure Sends Tenax Therapeutics Down 85% Premarket
TENX is trading near its 52-week low of $5.78 (65% below the low).
Summary
Tenax Therapeutics' Phase 3 LEVEL trial of TNX-103 for pulmonary hypertension missed its primary endpoint (six-minute walk distance) and key secondary endpoint (KCCQ symptom score). Shares crashed 85% in premarket trading to $2.07, wiping out most of the company's market cap. The company highlighted a potential benefit in a subgroup with greater disease burden and plans to request an FDA Type C meeting to discuss revisions to the registrational program. This follows the July 31 10-Q showing a $17.8M quarterly loss and $118M in cash, with runway to Q2 2028. The trial failure puts the entire oral levosimendan program at risk and raises questions about the company's ability to continue as a going concern if the FDA path is not viable.
Updates
· Benzinga — Shares closed down 89.49% to $1.79. Subgroup with baseline walk distance under 333 meters showed 26.3-meter benefit; NT-proBNP fell 49%.
At the time of this announcement, TENX was trading at $2.03 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $503M. The 52-week trading range was $5.78 to $19.40. This news item was assessed with negative market sentiment and an importance score of 10 out of 10. Source: Dow Jones Newswires.