reports
Tonix Pharmaceuticals Announces Presentation at BIO-Europe 2025
Tonix Pharmaceuticals Announces Presentation at BIO-Europe 2025 CHATHAM, N.J., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biopharmaceutical company announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at BIO-Europe 2025, being held November 3–5, 2025, in Vienna, Austria. The Company’s presentation will take place on Tuesday, November 4, at 3:00 p.m. CET in Presenting Company Theater 1 at the Vienna Congress and Convention Center. Dr. Lede...
Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl S...
Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT studyTreatment was well tolerated with minimal effects on weight or blood pressure and discontinuation rate of 19% vs. placebo of 20.8% Data support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic and therapeutic option for adults with fibromyalgia CHATHAM, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -...
Tonix Pharmaceuticals Announces First Patient Dosed in the Investigato...
Tonix Pharmaceuticals Announces First Patient Dosed in the Investigator-Initiated FOCUS Study of Tonix’s Intranasal Potentiated Oxytocin in AVP-D Conducted by Massachusetts General Hospital FOCUS is a randomized, double-blind, placebo-controlled crossover pilot study evaluating Tonix’s investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D)The trial is intended to generate preliminary data to inform future potential clinical studies of oxytocin replacement therapy in AVP-D CHATHAM, N.J., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Tonix Pha...
Tonix Pharmaceuticals to Present Poster on Tonmya™ at the 2025 America...
Tonix Pharmaceuticals to Present Poster on Tonmya™ at the 2025 American College of Rheumatology (ACR) Convergence CHATHAM, N.J., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, announced today that a poster on Tonmya™ (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, will be presented by Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, at the 2025 American College of Rheumatology Convergence, being held October 24–2...
Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World ...
Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025 TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models Data support advancement of TNX-801 toward clinical development CHATHAM, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”) presented data in an oral presentation at the World Vaccine Congre...
Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mA...
Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation CHATHAM, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled “The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Trans...
Tonix Pharmaceuticals to Present and Participate in Panel Discussion a...
Tonix Pharmaceuticals to Present and Participate in Panel Discussion at World Vaccine Congress, Europe 2025 CHATHAM, N.J., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Dr. Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research, will present and Dr. Bavari and Dr. Zeil Rosenberg, M.D., Executive Vice President, Medical will participate in a panel discussion at the World Vaccine C...
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team w...
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Hold...
Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 ...
Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of TNX-2900 (Intranasal Potentiated Oxytocin) in 2026 Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND TNX-2900 granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, providing the potential for a Priority Review Voucher upon approval Magnesium-potentiated intranasal oxytocin formulation designed to reduce dose-related inconsistencies in receptor activity ...
Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for ...
Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder Tonix anticipates filing the IND application in the fourth quarter of 2025 TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression TNX-102 SL is FDA-approved for the treatment of fibromyalgia CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today an...
Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclona...
Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800) Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1) Planning adaptive Phase 2/3 study Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutic...
Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatm...
Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025 Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue Tonmya was well tolerated, supporting its potential as a long-term treatment option for fi...
Tonix Pharmaceuticals to Participate in a Fireside Chat at the Cantor ...
Tonix Pharmaceuticals to Participate in a Fireside Chat at the Cantor Global Healthcare Conference 2025 CHATHAM, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Tonix’s Chief Executive Officer, will be participating in a fireside chat at the 2025 Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025 at 1:35 PM ET. A webcast of the fireside chat will be av...
Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzapri...
Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fourth quarter Company to host webcast and conference call on Monda...
Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results an...
Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights FDA PDUFA goal date of August 15, 2025, for TNX‑102 SL for fibromyalgia: if approved by FDA, TNX‑102 SL would be the first new drug for fibromyalgia in more than 16 years In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution Phase 3 RESILIENT results published in peer-reviewed journal, Pain Medicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102 SL; generally well tolerated Cash and ...
Tonix Pharmaceuticals Announces the Launch of the “Move Fibro Forward”...
Tonix Pharmaceuticals Announces the Launch of the “Move Fibro Forward” Campaign to Bring Awareness to Individuals Impacted by Fibromyalgia CHATHAM, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that Tonix Medicines, Inc., its commercial subsidiary, launched the Move Fibro Forward campaign to bring awareness and support to individuals impacted by fibromyalgia, a debilitating condition with no new FDA-approved treatments in over 15 years. “Millions of individuals impacted by fibromyalgia...
Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and S...
Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025 TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one year) in animals Subcutaneous administration of TNX-801 yielded equivalent protection to the traditional percutaneous administration CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical c...
Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIE...
Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine The previously disclosed and now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint of reducing fibromyalgia pain versus placebo, and was generally well tolerated These results confirm findings from the previously published RELIEF phase 3 trial, which also demonstrated a statistically significant reduction in fibromyalgia pain FDA target PDUFA date for...
Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox...
Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025 Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox TNX-801 confers durable protection after a single dose TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses CHATHAM, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical...
Tonix Pharmaceuticals Announces Peer-Reviewed Publication in Cancer Ce...
Tonix Pharmaceuticals Announces Peer-Reviewed Publication in Cancer Cell Journal Highlighting Positive Preclinical Data of mTNX-1700 in Gastric Cancer Animal Models Combination treatment of mTNX-1700 (mTFF2-MSA fusion protein) with anti-PD1 antibody was associated with increased survival and decreased metastases in animal models of gastric cancer relative to anti-PD1 treatment alone mTNX-1700 treatment was associated with activation of cancer-killing CD8+ T Cells and limiting neutrophil-mediated immune evasion TNX-1700 (hTFF2-HSA fusion protein) is in preclinical development for gastr...
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