TNX-102

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
  • LINK TO REGISTER
    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.

Tonix Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy

Retrieved on: 
Thursday, March 7, 2024
Incidence, TNX-102, Tonix Pharmaceuticals, ASR, University, Safety, Index, ASD, Trauma, SL2, OASIS, Efficacy, IND, Parmenter, Research, Pharmaceutical industry

CHATHAM, N.J., March 07, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the publication of a research paper in the Journal Psychiatry Research. The article titled, “A Phase 3, Randomized, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic Stress Disorder,” by Parmenter, et al. found that bedtime TNX-102 SL* treatment is well-tolerated and showed nominal improvement in PTSD severity and sleep quality measures in the first four weeks in military-related posttraumatic stress disorder (PTSD).1 The Company believes these findings suggest a potential role for short-term bedtime TNX-102 SL treatment in the immediate aftermath of traumatic events.

Key Points: 
  • The IND supporting the OASIS trial was recently cleared,3 and the trial is expected to begin enrolling in the second quarter.
  • In the OASIS study, 14 days of bedtime TNX-102 SL 5.6 mg will be tested in the immediate aftermath of motor vehicle collision.
  • “We believe the results in the published paper suggest that bedtime TNX-102 SL has short-term activity on improving PTSD symptom severity and sleep quality in military-related PTSD.
  • The upcoming OASIS trial will test a 14-day short-course of bedtime TNX-102 SL therapy beginning within 24 hours of index trauma for effects on ASR symptoms and incidence of PTSD development.

Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference

Retrieved on: 
Tuesday, February 20, 2024
Infection, Therapy, Fibromyalgia, TNX-102, Tonix Pharmaceuticals, Orphan drug, Smallpox, NIAID, Research, Annual report, NIH, CD40L, FDA, BIO, Prader–Willi syndrome, Sumatriptan, Government, Upsher-Smith Laboratories, Conference, Disease, Autoimmunity, University, COVID-19, PWS, Patient, Acute stress disorder, Security (finance), Long, Breakthrough therapy, Risk, IND, NDA, Failure, Long COVID, Cancer, Pharmaceutical industry

CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.

Key Points: 
  • CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.
  • Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
  • Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024.
  • A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024.

Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD

Retrieved on: 
Monday, February 12, 2024
Bangladesh Technical Education Board, School, TNX-102, ASR, Investigational New Drug, Survivor, Woman, Medical school, NIH, University, FDA, Partnership, Emergency medicine, Food, Sleep, ED, ASD, Trauma, Health, Safety, Observation, Patient, Acute stress disorder, UNC, Clinical trial, Knowledge, PTSD, Veteran, Psychiatry, IND, Verily, Pharmaceutical industry

CHATHAM, N.J., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL1 in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). The trial is sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).

Key Points: 
  • “There is an unmet need for treating ASR after traumatic events such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater.
  • Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.
  • The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative.
  • AURORA is a major national research initiative to improve the understanding, prevention, and recovery of individuals who experience a traumatic event.

Tenax Therapeutics Announces USPTO Grants Notice of Allowance for U.S. Patent Application, Significantly Broadening IP Protection for Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Retrieved on: 
Tuesday, February 6, 2024
Mortality, Patent, News, TNX-102, Exercise, Patient, PTE, Incidence, Intellectual property, Physician, Therapy, Heart failure, IP, Pharmaceutical industry

CHAPEL HILL, N.C., Feb. 06, 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 that the United States Patent and Trademark Office (USPTO) has allowed its patent application with claims covering the use of TNX-103 (oral levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients and, titled: ”LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).”

Key Points: 
  • It also indicates that IP protection will be provided for the use of combinations with various cardiovascular drugs, when used in PH-HFpEF patients.
  • This provides additional rationale for the future development of various drug-drug combinations with levosimendan,” said Chris Giordano, President & Chief Executive Officer of Tenax Therapeutics.
  • With no drugs yet approved for PH-HFpEF, levosimendan has already demonstrated its unique mechanism of action, K+ATP activation, in these patients.
  • Patients who transitioned to the oral daily formulation after a lengthy treatment with the weekly IV formulation improved further in their 6-minute walk results.

Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia

Retrieved on: 
Tuesday, January 9, 2024
Fibromyalgia, Woman, Biotechnology, Hydrogen chloride, Patient, Weight gain, Sleep, Female, Fatigue, TNX-102, Quality of life, Food, NDA, Safety, Human, Tonix Pharmaceuticals, FDA, Tablet, Pain, New Drug Application, Gabapentinoid, Blood pressure

CHATHAM, N.J., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at Biotech Showcase™ 2024 in San Francisco, January 8-10.

Key Points: 
  • As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.
  • RELIEF, the first Phase 3 trial of TNX-102 SL 5.6 mg in fibromyalgia, was completed in December 2020.

Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia

Retrieved on: 
Wednesday, December 20, 2023
Psychiatry, Quality of life, Abbreviation, Caregiver, Absorption, FDA, Pain, Fatigue, Tonix Pharmaceuticals, Medicine, University, NRS, Fibromyalgia, TNX-102, PROMIS, Sleep, Patient

CHATHAM, N.J., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia (Table 1). Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. Additionally, as it relates to improving daily pain, treatment with TNX-102 SL showed a robust and clinically meaningful analgesic effect size of 0.38, with rapid onset of action, separating from placebo for each week of the study. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed. Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. An estimated 6 million to 12 million U.S. adults are living with fibromyalgia, the majority of whom are women.

Key Points: 
  • TNX-102 SL is a non-opioid, centrally-acting analgesic, the active ingredient of which has a known, favorable safety profile from decades of use.
  • “The sublingual formulation of TNX-102 SL, which uses our proprietary Protectic® and Angstro® technologies, is integral to our treatment paradigm.
  • Consistent with the proposed mechanism that TNX-102 SL acts in fibromyalgia through improving sleep quality, TNX-102 SL showed statistically significant improvement of sleep by two main measures.
  • Adverse events resulted in premature study discontinuation in 6.1% of those who received TNX-102 SL compared with 3.5% of placebo recipients.

Tonix Pharmaceuticals Completes Clinical Stage of Phase 3 RESILIENT Study of TNX-102 SL for the Management of Fibromyalgia

Retrieved on: 
Wednesday, November 15, 2023
NDA, Tonix Pharmaceuticals, Sleep, Woman, TNX-102, Fibromyalgia, Food, SL2, Tablet, Fatigue, Patient, New Drug Application, FDA, Hydrogen chloride, Phase 3, COVID, Pharmaceutical industry, Delta

CHATHAM, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023.
  • “There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia.
  • TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies.

Tonix Pharmaceuticals Announces Department of Defense Grant to Support the University of North Carolina’s Proposed Investigator Sponsored OASIS Trial of TNX-102 SL for Treatment of Acute Stress Reaction, Acute Stress Disorder, and Posttraumatic Stress Dis

Retrieved on: 
Wednesday, September 27, 2023
OASIS, National Center for Telehealth & Technology, Survivor, Trauma, Medical school, Acute stress disorder, Traffic, UNC School of Medicine, Emergency medicine, University, Traumatic stress, Prevalence, UNC, United States Department of Defense, Food and Drug Administration, AURORA, One Mind, Woman, SL, University of North Carolina at Charlotte shooting, Veteran, Bangladesh Technical Education Board, Tablet, Hydrogen chloride, Investigational New Drug, Verily, Patient, Post-traumatic stress disorder, ASD, Risk, School, Alphabet, Psychiatry, Knowledge, Health, FDA, ASR, Safety, NIH, IND, Food, PTSD, TNX-102, Hospital, Meat, Pharmaceutical industry, Nursing, Tonix Pharmaceuticals, Medicine

CHATHAM, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that the University of North Carolina (UNC) Institute for Trauma Recovery has been awarded a $3 million grant from the Department of Defense (DoD) to investigate the potential of Tonix’s TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to reduce the frequency and severity of adverse effects of acute trauma. Such adverse effects include acute stress reaction (ASR), acute stress disorder (ASD), and posttraumatic stress disorder (PTSD). ASR refers to the body’s immediate response to trauma, whereas ASD represents the short-term effects of trauma, and PTSD represents the long-term effects of trauma.

Key Points: 
  • Such adverse effects include acute stress reaction (ASR), acute stress disorder (ASD), and posttraumatic stress disorder (PTSD).
  • ASR refers to the body’s immediate response to trauma, whereas ASD represents the short-term effects of trauma, and PTSD represents the long-term effects of trauma.
  • Participants will be randomized in the emergency department to receive a two-week course of either TNX-102 SL or placebo.
  • The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative.

Tenax Therapeutics Reports Fiscal Year 2021 Results and Provides Business Update

Retrieved on: 
Thursday, March 31, 2022
Health, Research, Pharmaceutical, Cardiology, Science, Biotechnology, Chronic kidney disease, Company, Risk, Therapy, Exercise, Journal, United States Patent and Trademark Office, Heart, Population, Splanchnic, PAH, Patent, Marketing, Hypertensive emergency, Heart Failure Society of America, Pulmonary hypertension, No, Board, TNX-102, Stomach, Culture, Cros, SEC, Program, Research, Patient, Cardiovascular disease, Levosimendan, Heart failure, U.S. Securities and Exchange Commission, USPTO, Board of directors, PH, OLE, Pharmacotherapy, IV, Safety, Stroke, American College, Orion Corporation, ATP, Nasdaq, COVID-19, Time, Imatinib, CRO, KOL, Annual report, Uncertainty, Disease, Security (finance), Heart failure with preserved ejection fraction, Pharmaceutical industry, Online gambling, Tenax

On January 12, announced that the United States Patent and Trademark Office (USPTO) granted Tenax a patent (No.

Key Points: 
  • On January 12, announced that the United States Patent and Trademark Office (USPTO) granted Tenax a patent (No.
  • In January 2021, Tenax purchased PHPrecisionMed Inc., a clinical stage biotechnology company focused on pulmonary hypertension, reflected in the operating results for the year ended December 31, 2021.
  • Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of levosimendan.
  • Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.