Tenax Therapeutics Inc

Tenax Therapeutics and Sionna Therapeutics shares plunged in premarket trading after their respective clinical trials failed, while MarineMax jumped on a reported buyout by Blackstone-owned Safe Harbor Marinas. Tenax stock fell 84.2% after its Phase 3 LEVEL trial of TNX-103 missed its primary endpoint, showing no statistically significant improvement in six-minute walk distance versus placebo with a p-value of 0.63. Sionna shares dropped 92.1% after its Phase 2a trial of SION-719 failed to demonstrate meaningful CFTR function improvement, with a placebo-adjusted sweat chloride change of just -1.0 mmol/L and a p-value of 0.7. MarineMax surged more than 34% after Reuters reported Safe Harbor is close to acquiring the boat retailer for $1.5 billion including debt, or about $53 per share in cash, a substantial premium to Friday's close of $35.68. AAON gained over 10.6% after its second-quarter results apparently beat expectations, while Silence Therapeutics rose 16.2% ahead of a conference call on its Phase 2 SANRECO trial. Dole fell 4.2% after missing second-quarter earnings and revenue estimates, and AirSculpt Technologies dropped 18.4% on weaker quarterly results with revenue down 3% year-over-year.

Orion Corporation's license partner Tenax Therapeutics announced that the Phase 3 LEVEL trial of oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo. The key secondary endpoint of improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score was also not met. Prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration to discuss revisions to the ongoing registrational development of levosimendan for PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency.

Tenax Therapeutics reported a wider net loss for its fiscal second quarter ended June 30, 2026, with the loss increasing 64% to $17.80 million from $10.85 million a year earlier. Diluted loss per share rose to $0.35 from $0.27 in the prior-year quarter. Cash and cash equivalents stood at $118 million as of June 30, 2026, and following $13.4 million in gross proceeds from warrant exercises during the quarter, the company expects its cash runway to extend through the second quarter of 2028. Tenax anticipates topline data in August 2026 from the Phase 3 LEVEL trial of TNX-103 for pulmonary hypertension associated with heart failure with preserved ejection fraction.