Tenax says Phase 3 LEVEL trial of TNX-103 in PH-HFpEF misses primary endpoint on 6-minute walk distance

Reuters2026/08/10 11:04

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Tenax Therapeutics reported topline Phase 3 LEVEL results for TNX-103 in PH-HFpEF; full data will be presented at ESC Congress 2026.
The trial missed its main efficacy goal in the overall study population, weakening the near-term regulatory case.
Prespecified analyses pointed to benefit in sicker patients, supporting a narrower target population and a potential revised path to approval.
Exploratory findings indicated favorable effects on cardiac stress and pulmonary pressure signals, despite the primary miss.
Tenax plans an FDA Type C meeting to discuss changes to the registrational program and an enrichment strategy for future studies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tenax Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608100700PRIMZONEFULLFEED9806732) on August 10, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Tenax says Phase 3 LEVEL trial of TNX-103 in PH-HFpEF misses primary endpoint on 6-minute walk distance

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