Tag: Tenax Therapeutics

Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023

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 […]

Tenax Granted Notice of Allowance for U.S. Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF)

Patent is expected to provide additional intellectual property protection until 2040 Prevalence estimates indicate that PH-HFpEF affects over 1,500,000 patients in the U.S. There are currently no FDA approved treatments for PH-HFpEF CHAPEL HILL, N.C., Feb. 01, 2023 (GLOBE NEWSWIRE) — […]

Tenax Therapeutics Announces Successful Comparative Pharmacokinetic Study of TNX-201 for the Treatment of Pulmonary Arterial Hypertension

TNX-201 (oral imatinib modified release tablets) Formulation Development has been Successfully Completed Manufacturing Underway to Support Phase 3 PAH Study (IMPROVE) MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that […]

Tenax Therapeutics Announces $8 Million PIPE Offering Priced At-the-Market under Nasdaq Rules

MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a definitive agreement with […]