Raised Gross Proceeds of Approximately $100 Million in a Private Placement with Leading Institutional Healthcare Investors Continuing to Enroll Patients in Phase 3 LEVEL Study with 52 Investigative Sites Now Initiated Cash Runway Through End of 2027 CHAPEL HILL, N.C., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying,... Read More

CHAPEL HILL, N.C., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it will participate in the Guggenheim Healthcare Innovation Conference in Boston, Massachusetts, from November... Read More

Raised Gross Proceeds of Approximately $100 Million in a Private Placement with Leading Institutional Healthcare Investors Continuing to Enroll Patients in Phase 3 LEVEL Study with 39 Investigative Sites Initiated In April, Hosted the KOL Event, “LEVEL Setting,” Featuring Four Experts in Heart Failure Discussing the Unmet Medical Need in PH-HFpEF and Potential of Levosimendan to Address Disease CHAPEL HILL, N.C., Aug. 13,... Read More

Funding supports advancement of oral levosimendan (TNX-103) Phase 3 development program, including completion of the ongoing LEVEL Study for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF) Proceeds also will fund the initiation of a second Phase 3 study planned for 2025, shortening timeline to NDA submission; the protocol for this study will be submitted to FDA for... Read More

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (the “Company” or “Tenax Therapeutics”), a Phase 3, development-stage 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 securities purchase agreement for an oversubscribed... Read More

Currently Enrolling Patients in Phase 3 LEVEL Study with 24 Investigative Sites Initiated Secured Global Development and Commercial Rights to Levosimendan for Treatment of PH-HFpEF Expanded Intellectual Property Estate for Levosimendan with Issuance of New U.S. Patent Recently Hosted KOL Event, “LEVEL Setting,” Featuring Four Experts in Heart Failure Discussing the Unmet Medical Need in PH-HFpEF and Potential of Levosimendan... Read More

Broadens IP protection for oral (TNX-103), IV, and subcutaneous use of levosimendan, and its active metabolites (OR1896 and OR1855), in PH-HFpEF Provides U.S. intellectual property (IP) protection until December 2040, and may qualify for additional U.S. patent term extension (PTE) beyond 2040 Expressly provides IP protection for levosimendan at all therapeutic doses for use in PH-HFpEF Expressly provides IP protection for... Read More

Panel of renowned cardiologists, all globally recognized experts in heart failure, will discuss the unmet medical need in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) and the potential role for levosimendan in treating this prevalent, fatal disease Experts will explain pathophysiology of PH-HFpEF, and mechanistic rationale for levosimendan Update on the ongoing Phase 3 LEVEL Study... Read More

First Patient Enrolled in Phase 3 LEVEL Trial Evaluating TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension from Heart Failure with Preserved Ejection Fraction (PH-HFpEF) Expansion of U.S. Intellectual Property Covering the Use of Levosimendan for the Treatment of PH-HFpEF and for Use in Combination with Other Cardiovascular Therapies The Company Secured Global Commercial Rights to Levosimendan for the... Read More

CHAPEL HILL, N.C., March 12, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it will participate in the 36 th Annual Roth Conference in Dana Point, California, from March 17-19, 2024. Tenax’s... Read More

Dr. Sanjiv Shah, a renowned, global expert in the treatment of HFpEF and PH-HFpEF, will present data highlighting the use of levosimendan for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) Presentation will occur at Technology and Heart Failure Therapeutics (THT-2024) – in Boston, MA, on March 6, 2024 THT 2024 is an international conference of leading Heart Failure... Read More

Amendment to existing exclusive license agreement with Orion Corporation expands Tenax’s territory rights from North America, to the entire world Expanded rights position Tenax to engage potential global strategic pharmaceutical partners Improved net sales royalty rate structure, now ranging from high single-digit to low-teen percentages. Lowered maximum cost of goods Modified milestone provisions, including additional... Read More

CHAPEL HILL, N.C., Feb. 08, 2024 (GLOBE NEWSWIRE) -- 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, announced today the pricing of a public offering of (i) 1,600,000 shares of its common stock (or pre-funded warrants in lieu thereof) and (ii) warrants to... Read More

Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations Tenax forecasts topline LEVEL data will be available second half of 2025 CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty... Read More

Once granted, this patent will: provide U.S. intellectual property (IP) protection until December 2040, and may qualify for additional U.S. patent term extension (PTE) beyond 2040 broaden IP protection for oral (TNX-103), IV, and subcutaneous use of levosimendan, and its active metabolites (OR1896 and OR1855), in PH-HFpEF expressly provide IP protection for levosimendan at all therapeutic doses for use in PH-HFpEF expressly... Read More

CHAPEL HILL, N.C., Dec. 29, 2023 (GLOBE NEWSWIRE) -- 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, announced today that it will be executing a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-80. The reverse stock split... Read More

CHAPEL HILL, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- 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 the appointment of Javed Butler, M.D., M.P.H, M.B.A., to the Company’s PH-HFpEF Scientific Advisory Board (SAB). “We are thrilled to... Read More

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 year (minimum requirements per ICH guidelines) No FDA requirement for a cardiovascular outcomes trial Oral levosimendan use in PH-HFpEF... Read More

New U.S. patent provides intellectual property (IP) protection until December 2040, and may qualify for term extension beyond 2040 There are currently no FDA-approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030 Broadens Tenax’s U.S. IP protection for a market with the potential to generate billions in future... Read More

Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond 2040 There are currently no FDA approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030 Once granted, this patent will significantly broaden Tenax’s U.S.... Read More

Company to prioritize the clinical development of TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) PH-HFpEF affects more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030 Strategic decision based upon this significant unmet medical need, no FDA-approved therapies, and an expanding... Read More

Patent provides intellectual property protection until December 2040 PH-HFpEF affects more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030 There are currently no FDA approved treatments for PH-HFpEF Levosimendan combines two MoAs that, for the first time, specifically target the symptoms PH-HFpEF patients suffer. CHAPEL HILL, N.C., March 22, 2023 (GLOBE NEWSWIRE)... Read More

CHAPEL HILL, N.C., Feb. 03, 2023 (GLOBE NEWSWIRE) -- 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, announced today the pricing of a public offering of (i) 8,666,666 shares of its common stock (or pre-funded warrants in lieu thereof) and (ii) warrants to... Read More

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, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products... Read More

MORRISVILLE, N.C., Jan. 04, 2023 (GLOBE NEWSWIRE) -- 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, announced today that it will be executing a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20. The reverse stock split... Read More