Unapproved in US for decades, levosimendan stumbles in phase 3 as Tenax eyes narrow FDA path on August 11, 2026 6-minute walk distance levosimendan Multiple Acyl Coenzyme A Dehydrogenase Deficiency PH-HFpEF primary endpoint Tenax Therapeutics Type C meeting U.S. unapproved United States Food and Drug Administration +