Tenax Therapeutics, Inc. is a pharmaceutical company engaged in the development and commercialization of products for cardiovascular and pulmonary diseases. The company was founded on May 26, 1967 and is headquartered in Chapel Hill, NC.
Clinical Trials
9
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1967
Active, not recruiting
1
11.1%
Completed
3
33.3%
Enrolling By Invitation
1
11.1%
No Longer Available
1
11.1%
Recruiting
1
11.1%
Terminated
2
22.2%
No approval data available
- Tenax Therapeutics' oral levosimendan (TNX-103) failed to improve 6-minute walk distance versus placebo in the Phase 3 LEVEL trial for pulmonary hypertension due to HFpEF. - The drug also missed the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score. - A subgroup of patients with more severe disease showed a 26-metre improvement in walk distance and a 49% decrease in NT-proBNP, prompting the company to seek FDA and EMA guidance. - Tenax shares fell more than 85% following the readout, with full results expected at the ESC congress in Munich.
- LifeSci Capital analyst Gaurav Maini reiterated a Buy rating on Tenax Therapeutics (TENX) with a $35.00 price target. - The broader analyst consensus rates Tenax Therapeutics as a Strong Buy with an average price target of $37.40. - Tenax Therapeutics reported a GAAP net loss of $15.72 million for the quarter ending March 31, compared to a $10.41 million loss in the prior-year period. - Analyst Gaurav Maini holds a 4-star rating on TipRanks with a 30.8% average return and a 100% success rate.
- The European Patent Office has issued an intention to grant Tenax Therapeutics patent protection for levosimendan use in pulmonary hypertension with heart failure and preserved ejection fraction through December 2040. - The patent covers TNX-103 oral levosimendan and other formulations across multiple administration routes, strengthening Tenax's intellectual property portfolio for this first-in-disease drug candidate. - This European protection comes as Tenax prepares to initiate its second Phase 3 registrational study LEVEL-2, which will recruit patients across Europe this year. - The patent provides commercial protection in a European market where patient prevalence estimates approximate those in North America for this condition with no approved treatments.
• Tenax Therapeutics has secured a $25 million private placement from RTW Investments to fund ongoing and planned Phase 3 clinical trials for novel cardiopulmonary therapies. • The financing includes 378,346 shares of common stock and pre-funded warrants for 3,760,726 shares, with Leerink Partners leading the placement alongside Guggenheim Securities and William Blair. • The strategic investment will strengthen Tenax's position in developing innovative cardiopulmonary treatments, with proceeds directed towards clinical advancement and general corporate operations.
- Tenax Therapeutics receives FDA approval to expand its ongoing LEVEL study to 230 patients, increasing statistical power to over 95% for their oral levosimendan (TNX-103) trial in PH-HFpEF treatment. - The company secured FDA agreement to initiate LEVEL-2, a second global Phase 3 study, with patient enrollment expected to begin in 2025, strengthening their clinical development program. - Initial blinded data shows promising safety profile with over 95% patient retention and therapy continuation rates, supported by $100 million financing secured in August 2024.
• Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103). • Ms. Andor brings over 20 years of experience in clinical operations, including NDA submissions and approvals, to accelerate the Phase 3 LEVEL study. • Her expertise will be crucial as Tenax Therapeutics advances oral levosimendan for pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). • The appointment signifies Tenax's commitment to strengthening its clinical development capabilities as it prepares for potential global regulatory filings.
- Tenax Therapeutics is developing levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition affecting over 2 million U.S. patients. - Phase II HELP trial data indicated levosimendan prevented increased stress blood volume during exertion, significantly improving six-minute walk distance. - The company is currently enrolling patients in the Phase III LEVEL trial, with results expected in the second half of 2025, potentially de-risking the program. - Levosimendan has demonstrated unique properties including inotropic support and vasodilation across multiple heart failure indications.
