Unapproved in US for decades, levosimendan stumbles in phase 3 as Tenax eyes narrow FDA path

Tenax Therapeutics' oral levosimendan failed the primary endpoint in a phase 3 trial for pulmonary hypertension due to heart failure, but showed positive results in a prespecified subgroup with greater disease severity, prompting plans for FDA discussions on a narrow approval path.

This Wire brief sits within Fusion42's coverage of Biotech.