Phase 3 Heart Drug Trial Misses Primary Endpoint, Stock Plunges 89%
TENX is trading near its 52-week low of $1.31 (6.5% above the low) on elevated volume (25× avg).
Summary
Tenax's Phase 3 LEVEL trial of oral levosimendan (TNX-103) for PH-HFpEF missed its primary endpoint — a 3.5-meter improvement in six-minute walk distance vs placebo, not statistically significant. The key secondary symptom score endpoint also failed, with a 0.1-point difference. Shares crashed 89.49% to $1.79, wiping out most of the company's ~$500M market cap. Despite the miss, prespecified subgroup analyses showed a 26.3-meter benefit in patients with baseline walk distance under 333 meters, and exploratory biomarkers revealed a 49% reduction in NT-proBNP and significant drops in right ventricular systolic pressure. The company plans to request a Type C meeting with the FDA to discuss an enriched study design and will seek European scientific consultation. This follows the earlier Dow Jones report of the trial miss, but adds granular data and the massive intraday price move. With $118M in cash and runway to Q2 2028, Tenax has time to pivot, but the core asset's future is now highly uncertain.
At the time of this announcement, TENX was trading at $1.40 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $503M. The 52-week trading range was $1.31 to $19.40. This news item was assessed with negative market sentiment and an importance score of 10 out of 10. Source: Benzinga.