Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with …

First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study) • FDA agreement that 6MWD will be the primary endpoint for both Phase 3 studies • Phase 3 program designed to satisfy FDA's request for subject drug exposure of 300 patients for 6 months, 100 patients for 1…#firstphase3 #fda #6mwd #phase3 #oral #uspto #hill #tenaxtherapeuticsinc #levosimendan #chrisgiordano
Source: Reuters: Health - Category: Consumer Health News Source Type: news