Tonix Pharmaceuticals Hld

Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company, which focuses on the discovery, acquisition, and development of small molecules and biologics to treat and prevent human disease and alleviate suffering. Its portfolio includes TNX-102 SL, TNX-601, TNX-801, and TNX-1800. The company was founded by Seth Lederman and Donald W. Landry on November 16, 2007 and is headquartered in Chatham, NJ.

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The study did not achieve statistical significance on the primary endpoint Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study Tonix expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept double-blind, randomized, multi-center, placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) in patients with major depressive disorder (MDD).

Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital TNX-1500 is currently in Phase 1 Clinical Development Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication; Multiple Other Indications, including Autoimmune Disorders, are Planned CHATHAM, N.J., Oct. 30, 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 data from two oral presentations which were delivered recently at the American College of Surgeons (ACS) Clinical Congress 2023, and The International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in October 2023.

Tonix Pharmaceuticals Announces New Data Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) in Heart Xenotransplantation in Animal Models at the ACS Clinical Congress and IPITA-IXA-CTRMS Joint Congress

Tonix Pharmaceuticals (NASDAQ:TNXP) said it expects to receive the topline results from its 88-patient Phase 2 PREVENTION study of its investigation drug TNX-1900 for the prevention of migraine headaches in chronic migraineurs in early December 2023. “With the last patient now treated, we look forward to analysis of the results of this proof-of-concept study, which will help to inform our plans as we discuss next steps with the U.S. Food and Drug Administration (FDA),” Tomix chief medical officer Dr. Gregory Sullivan said.

Tonix Pharmaceuticals expects topline results from migraine prevention study in December

Topline results expected early December 2023 Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic effects of oxytocin on the oxytocin receptor in animal models TNX-1900 blocks release of CGRP, a key peptide in the pathogenesis of migraine, from trigeminal ganglia neurons while limiting systemic exposure CHATHAM, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 2 proof-of-concept, double-blind, randomized, placebo-controlled PREVENTION1 study of TNX-19002 (intranasal potentiated oxytocin) as a potential treatment for the prevention of migraine headaches in chronic migraineurs.

Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 PREVENTION Study of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs

Tonix's Therapeutic Development Program is Aligned with National Goal for Better Solutions TONIX: Effect of TNX-102 SL on Fatigue in Proof-of-Concept Phase 2 Study Sets Stage for Developing Protocols for Registrational Phase 3 Study in Fibromyalgia-type Long COVID. CHATHAM, NJ / ACCESSWIRE / October 25, 2023 / COVID is an acute disease that comes and goes, but for a growing number of people, the sequelae to the infection - the aftereffects - can become a constellation of symptoms called long COVID that may affect sufferers for years, if not a lifetime.

New Hope for Long COVID Sufferers

Preclinical Data Demonstrate Attenuation of TNX‐801 (horsepox live virus vaccine) Compared to Modern Vaccinia Vaccines

Tonix Pharmaceuticals Presents Data from its Horsepox-Based Vaccine Development Platform at the World Vaccine Congress Europe

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital TNX-1500 is Enrolling in a Phase 1 Clinical Trial Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication: Multiple Other Indications, including Autoimmune Disorders, are Planned CHATHAM, N.J., Oct. 18, 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 a study published in the Journal Nature 1 by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with biotechnology company, eGenesis, utilized TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal antibody [mAb]) as part of the immune modulating regimen to prevent organ transplant rejection.

Tonix Pharmaceuticals Announces Publication of Data in the Journal Nature Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) for the Prevention of Rejection in Kidney Xenotransplantation in Animal Models

Topline Results Expected Early November 2023 Tianeptine, the Active Ingredient in TNX-601 ER, is Not Associated with Sexual Dysfunction or Weight Gain Which are Treatment-Limiting Side Effects of Many Traditional Antidepressants Tianeptine Acts by Directly Restoring Neuroplasticity and Neurogenesis and Limiting the Effects of Oxidative Stress in the Brain CHATHAM, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 potential registration-quality, double-blind, randomized, multicenter, placebo-controlled UPLIFT1 study of TNX-601 ER2 (tianeptine hemioxalate extended-release tablets) as a potential treatment for major depressive disorder (MDD).

Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 UPLIFT Study of TNX-601 ER for the Treatment of Major Depressive Disorder

CHATHAM, N.J., Oct. 12, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Thursday, October 19, 2023, at 8:00 a.m. ET, and host investor meetings. The conference is being held at the Mandarin Oriental, New York in New York City.

Tonix Pharmaceuticals to Present at the 2023 ThinkEquity Conference

CHATHAM, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals, will present at the World Vaccine Congress Europe on Wednesday, October 18, 2023, at 2:45 p.m. CEST in Barcelona, Spain.

Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine Congress Europe

CHATHAM, N.J., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, provided an overview of Tonix's TNX-2900 (potentiated intranasal oxytocin) program at the Foundation for Prader-Willi Research (FPWR) Family Conference in Denver, CO. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. Additional information can be found on the FPWR conference website here.

Tonix Pharmaceuticals Provides Overview of TNX-2900 Program for the Treatment of Prader-Willi Syndrome at the Foundation for Prader-Willi Research Family Conference

New patent expected to expire in 2036 Proof of concept data from Phase 2 study for prevention of migraine headache expected in early December 2023 CHATHAM, N.J., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the European Patent Office (EPO) issued European Patent No.

Tonix Pharmaceuticals Announces Issuance of EU Patent Covering Intranasal Potentiated Oxytocin (TNX-1900) for the Treatment of Pain

Tonix Pharmaceuticals (NASDAQ: TNXP ) stock is falling hard on Friday after the clinical-stage biopharmaceutical company priced a share offering. According to a press release from Tonix Pharmaceuticals, it has entered into a securities purchase agreement with certain healthcare institutional investors.

Why Is Tonix Pharmaceuticals (TNXP) Stock Down 29% Today?

CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into securities purchase agreements with healthcare focused institutional investors for the purchase and sale of 9,000,000 shares of its common stock (or common stock equivalents in lieu thereof) together with Series A warrants to purchase up to an aggregate of 9,000,000 shares of common stock and Series B warrants to purchase up to an aggregate of 9,000,000 shares of common stock in a public offering at a combined offering price of $0.50 per share (or common stock equivalents in lieu thereof) and accompanying Series A and Series B warrant. The Series A and Series B warrants will have an exercise price of $0.50 per share, will be exercisable immediately, and will expire in five years and one year, respectively. The closing of the public offering is expected to take place on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

Tonix Pharmaceuticals Announces Pricing of $4.5 Million Public Offering

$3 million awarded by DoD to University of North Carolina Institute of Trauma Recovery to support a proposed 180-patient, randomized, placebo-controlled trial in acute trauma patients

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

mTNX-1700 (mTFF2-MSA) suppresses tumor growth and increases survival rates in preclinical colorectal cancer models mTNX-1700 shows single agent activity and additive effects in combination with anti-PD-1 mTNX-1700 targets myeloid-derived suppressor cells (MDSCs) in a novel mechanism to treat cancer CHATHAM, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation showing research results for mTNX-1700 (murine trefoil factor family member 2- murine serum albumin, or mTFF2-MSA) at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival, being held September 20-23, 2023, in Milan, Italy.

Tonix Pharmaceuticals Presents New Preclinical Data at Seventh International Cancer Immunotherapy Conference 2023

Oxytocin receptors and CGRP are co-expressed on human trigeminal ganglia neurons and their expression is increased in inflammation

Tonix Pharmaceuticals Announces Presentation of Non-Clinical Studies Supporting the Mechanism of TNX-1900 (Intranasal Potentiated Oxytocin) at the 2023 International Headache Congress

CHATHAM, N.J., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a poster presentation at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival. The Conference is being held September 20-23, 2023, in Milan, Italy. A copy of the poster will be made available on the Tonix Pharmaceuticals website following the presentation at www.tonixpharma.com.

Tonix Pharmaceuticals Announces Poster Presentation Involving TNX-1700 in Preclinical Colorectal Cancer Models at the Seventh International Cancer Immunotherapy Conference 2023

Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND

Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-801 as a Potential Vaccine to Prevent Mpox and Smallpox

CHATHAM, N.J., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present at the August 2023 Virtual Investor Summit on Thursday, August 24, 2023, at 10:00 a.m. ET.

Tonix Pharmaceuticals to Present at the August Virtual Investor Summit

Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500

Tonix Pharmaceuticals Initiates Phase 1 Trial of TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Topline Results from Four CNS Clinical Trials Expected in the Third and Fourth Quarters of 2023 Fibromyalgia Topline Results Expected in the Fourth Quarter of 2023 for Phase 3 Potentially NDA-Enabling Study of the Centrally-Acting Non-Opioid Analgesic TNX-102 SL Completed Strategic Acquisition of Two Marketed Acute Migraine Products: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) CHATHAM, N.J., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2023, and provided an overview of recent operational highlights.

Tonix Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Highlights

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Topline Results Expected Third Quarter 2023 Long COVID Afflicts Approximately 19% of Patients Following COVID-19 1 , and is Expected to be a Global Health Burden Fibromyalgia-Type Long COVID with Multi-Site Pain Affects Approximately 40% of Long COVID Patients CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID.

Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID

CHATHAM, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced the closing of its public offering of 7,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,000,000 shares of common stock in a public offering at a combined offering price of $1.00 per share (or common stock equivalents in lieu thereof) and accompanying warrant. The warrants have an exercise price of $1.00 per share, became exercisable upon issuance, and will expire five years following the issuance date.

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