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09.12.2025
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Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel
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Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry...
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24.11.2025
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Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder
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Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026...
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17.11.2025
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Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment
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TONMYA is now available by prescription and available for pharmacy ordering nationwide...
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10.11.2025
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Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights
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Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November...
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04.11.2025
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Tonix Pharmaceuticals Announces Collaboration with Massachusetts General Hospital to Advance Phase 2 Clinical Trial of Dimeric Fc-modified anti-CD40L mAb, TNX-1500, to Prevent Kidney Transplant Organ Rejection
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Planning to initiate an open-label Phase 2 study of TNX-1500 under an investigator-initiated IND to evaluate safety and activity in the first half of 2026 ...
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27.10.2025
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Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence
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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 the...
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22.10.2025
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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
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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...
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21.10.2025
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Tonix Pharmaceuticals to Present Poster on Tonmya™ at the 2025 American College of Rheumatology (ACR) Convergence
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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....
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17.10.2025
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Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025
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TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox...
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09.10.2025
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Tonix Pharmaceuticals to Present and Participate in Panel Discussion at World Vaccine Congress, Europe 2025
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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 a...
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© Globe Newswire
30.09.2025
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Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access
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Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix...
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29.09.2025
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Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of TNX-2900 (Intranasal Potentiated Oxytocin) in 2026
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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...
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18.09.2025
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Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder
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Tonix anticipates filing the IND application in the fourth quarter of 2025...
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17.09.2025
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Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)
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Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1)...
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© Globe Newswire
15.08.2025
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Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia
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Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years...
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© Globe Newswire
11.08.2025
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Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights
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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 ...
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© Globe Newswire
21.07.2025
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Tonix Pharmaceuticals Announces the Launch of the “Move Fibro Forward” Campaign to Bring Awareness to Individuals Impacted by Fibromyalgia
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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 condit...
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© Globe Newswire
10.07.2025
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Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025
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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...
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© Globe Newswire
02.07.2025
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Tonix Pharmaceuticals Announces Peer-Reviewed Publication in Cancer Cell Journal Highlighting Positive Preclinical Data of mTNX-1700 in Gastric Cancer Animal Models
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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...
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© Globe Newswire
30.06.2025
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Tonix Pharmaceuticals Announces Inclusion in the Russell 3000® and Russell 2000® Indexes
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CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000® Index, with automatic inclusion in the small-cap Russell 2000® Index, after the open of U.S. equity markets to...
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© Globe Newswire
13.06.2025
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Tonix Pharmaceuticals Announces Appointment of Commercial Industry Veteran, James “Jim” Hunter, to Board of Directors
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Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis...
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© Globe Newswire
21.05.2025
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Tonix Pharmaceuticals Announces First Patient Dosed in Phase 2 OASIS Study of TNX-102 SL for Reduction of Acute Stress Reaction
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Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD)...
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© Globe Newswire
12.05.2025
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Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights
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FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years...
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© Globe Newswire
16.04.2025
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Tonix Pharmaceuticals Announces Oral Presentation and Panel Participation at the World Vaccine Congress Washington 2025
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CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vacci...
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© Globe Newswire
09.04.2025
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Tonix Pharmaceuticals and Makana Therapeutics Announce Collaboration Combining Tonix’s Anti-CD40L Monoclonal Antibody (TNX-1500) with Makana’s Genetically Engineered Organs in Preclinical and Clinical Xenotransplantation Studies
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Agreement includes the use of Tonix’s TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana’s genetically engineered pig organs in xenotransplantation...
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© Globe Newswire
07.04.2025
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Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting
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TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia...
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© Globe Newswire
18.03.2025
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Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
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August 15, 2025, is the FDA PDUFA goal date for TNX-102 SL for the management of fibromyalgia; If approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years...
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© Globe Newswire
11.03.2025
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Tonix Pharmaceuticals to Present at the Zacks SCR Life Sciences Virtual Investor Forum on March 13th
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CHATHAM, N.J., March 11, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the Zacks SCR Life Sciences V...
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© Globe Newswire
06.02.2025
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Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases
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Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection...
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© Globe Newswire
05.02.2025
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Tonix Pharmaceuticals to Participate in the 2025 BIO CEO & Investor Conference
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CHATHAM, N.J., Feb. 05, 2025 (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 C...
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© Globe Newswire
04.02.2025
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Tonix Pharmaceuticals Promotes Siobhan Fogarty to Chief Technical Officer
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Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development...
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© Globe Newswire
03.02.2025
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Tonix Pharmaceuticals Announces 1-for-100 Reverse Stock Split
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CHATHAM, N.J., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse s...
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© Globe Newswire
23.12.2024
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Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
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Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025...
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© Globe Newswire
03.12.2024
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Tonix Pharmaceuticals Announces Expansion of Leadership Team with Two Strategic Hires
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Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products...
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© Globe Newswire
26.11.2024
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Tonix Pharmaceuticals to Participate in the NobleCon20 Investor Conference
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CHATHAM, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present and conduct in...
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© Globe Newswire
18.11.2024
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Tonix Pharmaceuticals to Present at the Winter 2024 Investor Summit Virtual
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CHATHAM, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated 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 Winter...
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© Globe Newswire
13.11.2024
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Tonix Pharmaceuticals Announces Peer-Reviewed Publication in mSphere Journal Highlighting the Tolerability of Company’s Single-Dose Mpox and Smallpox Vaccine Candidate TNX-801, in Immune-Compromised Animals
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The World Health Organization (WHO) declared the spread of new Clade Ib Mpox a public health emergency of international concern (PHEIC): Second Mpox-related WHO PHEIC declaration in two years...
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© Globe Newswire
12.11.2024
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Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights
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Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies...
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© Globe Newswire
01.11.2024
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Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024
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New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals...
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© Globe Newswire
29.10.2024
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Tonix Pharmaceuticals to Present at BIO-Europe® 2024
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CHATHAM, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at BIO-Eu...
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© Globe Newswire
25.10.2024
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Tonix Pharmaceuticals to Present at the 2024 ThinkEquity Conference
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CHATHAM, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated 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 ThinkEq...
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© Globe Newswire
16.10.2024
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Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
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NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated...
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© Globe Newswire
27.09.2024
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Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace® SymTouch® to Treat Migraines
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New patent expected to provide market exclusivity into 2036...
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© Globe Newswire
19.09.2024
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Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office Covering the Intranasal Delivery of FDA-Approved Tosymra® to Treat Migraines
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New patent expected to expire in 2030...
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© Globe Newswire
16.09.2024
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Tonix Pharmaceuticals Announces That its Single Dose Mpox Vaccine Candidate TNX-801 Aligns with WHO’s Newly Issued Preferred Target Product Profile for Mpox Vaccines in Global Health Emergency
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The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30...
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© Globe Newswire
10.09.2024
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Tonix Pharmaceuticals Announces Appointment of Thomas Englese as Executive Vice President of Commercial Operations
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Thomas brings more than 20 years of commercial and operations experience in the biopharmaceutical industry to Tonix...
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© Globe Newswire
06.09.2024
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Tonix Pharmaceuticals Launches National Awareness Campaign on the Impact of Gastroparesis or Stomach Paralysis on the Absorption of Oral Migraine Medications at PAINWeek
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Gastroparesis slows the ability of the stomach to empty into the small intestine and thereby can delay absorption of oral medications into the bloodstream...
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© Globe Newswire
29.08.2024
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Tonix Pharmaceuticals Presented Data from Two Posters on TNX-102 SL for Reduction of Acute Stress Reaction and Prevention of PTSD and One Poster for Wound Healing at the 2024 Military Health System Research Symposium (MHSRS)
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Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024...
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© Globe Newswire
26.08.2024
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Tonix Pharmaceuticals and Bilthoven Biologicals to Collaborate on Advancing Development of Tonix’s Mpox Vaccine, TNX-801
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World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years...
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© Globe Newswire
20.08.2024
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Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 CATALYST Study of TNX-1300 for the Treatment of Cocaine Intoxication
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CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department...
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© Globe Newswire
19.08.2024
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Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights
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On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024...
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© Globe Newswire
16.08.2024
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Tonix Pharmaceuticals Provides Update on the Development of Its Single Dose Live Attenuated Virus Vaccine Candidate for Mpox, TNX-801, as WHO Declares Mpox Outbreak a Global Health Emergency
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World Health Organization (WHO) has declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) 1...
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© Globe Newswire
31.07.2024
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Tonix Pharmaceuticals Announces Potential Positive Impact of the U.S. National Academies (NASEM) New Definition of Long COVID on the Size of the Fibromyalgia Market for Tonmya™
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Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1...
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© Globe Newswire
25.07.2024
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Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia
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Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need...
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© Globe Newswire
10.07.2024
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Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering
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CHATHAM, N.J., July 10, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 3,393,600 shares of its common stock and pre-funded warrants to purchase up to 3,703,140 shares of common stock in a pub...
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© Globe Newswire
09.07.2024
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Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public Offering
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CHATHAM, N.J., July 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 7,096,740 shares of its common stock (or pre-funded warrants in lieu thereof) at...
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© Globe Newswire
08.07.2024
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Tonix Pharmaceuticals Announces Proposed Public Offering
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CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to...
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© Globe Newswire
28.06.2024
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Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering
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CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a pub...
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© Globe Newswire
26.06.2024
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Tonix Pharmaceuticals Announces Proposed Public Offering
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CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to...
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© Globe Newswire
26.06.2024
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Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement
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CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a lett...
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