$TNXP News
Last published 2d ago
- 2d agoTNXPTonix Pharmaceuticals Holding Corp. - EX-99.01Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 2d agoTNXPTonix Pharmaceuticals Reports Third Quarter 2026 Financial Results and Operational HighlightsGlobeNewswireThird quarter TONMYA® net sales of approximately $15 million, up 37% from the second quarter Approximately $163 million in cash and cash equivalents as of September 30, 2026 Strategic focus on supporting TONMYA growth
- 1w agoTNXPTonix Pharmaceuticals to Present at Guggenheim’s 3rd Annual Healthcare Innovation ConferenceGlobeNewswireBERKELEY HEIGHTS, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or "the Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 1w agoTNXPTonix Pharmaceuticals Appoints George Lederman, Ph.D., as Executive Vice President of Strategy and TransformationGlobeNewswireBERKELEY HEIGHTS, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 2w agoTNXPTonix Pharmaceuticals Presented an Analysis of Phase 3 Data Demonstrating TONMYA® Improved Physical Symptoms and Functional Ability of Patients with Fibromyalgia at the IASP 2026 World Congress on PainGlobeNewswireTONMYA improved Fibromyalgia Impact Questionnaire-Revised (FIQR) symptoms and function scores versus placebo in both domains at Week 14 in RELIEF and RESILIENT Phase 3 pivotal studies Tonix commercially launched
- 2w agoTNXPTonix Pharmaceuticals to Report Third Quarter 2026 Financial Results on November 9, 2026GlobeNewswireBERKELEY HEIGHTS, N.J., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biotechnology company, today
- 3w agoTNXPTonix Pharmaceuticals to Present an Analysis of Phase 3 Data on TONMYA® at the IASP 2026 World Congress on PainGlobeNewswireBERKELEY HEIGHTS, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 3w agoTNXPTonix Pharmaceuticals Announces Presentations at World Vaccine Congress Europe 2026GlobeNewswireBERKELEY HEIGHTS, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or "the Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 2mo agoTNXPTonix Pharmaceuticals Promotes Thomas Englese, MBA, to Chief Commercial OfficerGlobeNewswireBERKELEY HEIGHTS, N.J., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 2mo agoTNXPTonix Pharmaceuticals to Participate in Cantor’s 2026 Global Healthcare ConferenceGlobeNewswireBERKELEY HEIGHTS, N.J., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biopharmaceutical company,
- 3mo agoTNXPCG 46TH ANNUAL GROWTH CONFERENCE - TONIX PHARMACEUTICALS HOLDING CORPEarnings Call TranscriptsI'm Gary Nachman, a senior biopharma biotech analyst at Canaccord Genuity, and we're very excited to have Seth Letterman, CEO of Tonics Pharmaceuticals, with us to discuss some recent exciting developments at the company
- 3mo agoTNXPTonix Pharmaceuticals Q2 2026 Earnings Conference Call - TONIX PHARMACEUTICALS HOLDING CORPEarnings Call TranscriptsGood morning and welcome to Tonics Pharmaceuticals' second quarter 2026 financial results and business update conference call. At this time, all participants are in listen-only mode. Following management's prepared remar
- 3mo agoTNXPTonix Pharmaceuticals Reports Second Quarter 2026 Financial Results and Operational HighlightsGlobeNewswireTONMYA® net sales totaled approximately $11 million, an increase of 197% quarter-over-quarter Commercial and government payer coverage for TONMYA meaningfully expanded, now reaching approximately 136 million covered
- 3mo agoTNXPTonix Pharmaceuticals to Participate in Upcoming Investor ConferencesGlobeNewswireBERKELEY HEIGHTS, N.J., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biotechnology company, today
- 3mo agoTNXPTonix Pharmaceuticals Announces Positive Minutes from Type C FDA Meeting to Discuss Adaptive Phase 2 Field Study of TNX-4800, a Human, anti-OspA Monoclonal Antibody, to Prevent Lyme Disease in the U.S.GlobeNewswireAlignment with FDA on key elements of the study design support planned start of the Phase 2 study in the first quarter of 2027 Long-acting monoclonal antibody TNX-4800 is a rapidly acting alternative to vaccination
- 3mo agoTNXPTonix Pharmaceuticals to Report Second Quarter 2026 Financial Results on August 10, 2026GlobeNewswireBERKELEY HEIGHTS, N.J., July 27, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biotechnology company, today
- 3mo agoTNXPTonix Pharmaceuticals Announces Publication in the Peer-Reviewed Journal of Virology Assessing Virulence of the 2022 Outbreak Strain of Mpox in New Animal ModelsGlobeNewswireData show clade IIb from 2022 outbreak is 100 to 100,000-fold less virulent than clade IIa from 2003 outbreak Three new models for investigating mpox infection and pathogenesis identified Tonix is advancing
- 4mo agoTNXPTonix Pharmaceuticals Announces Major Managed Medicare Payer Agreement for TONMYA®GlobeNewswireNew agreement, effective January 1, 2027, to add approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.) On top of two previously announced major commercial payer agreements
- 4mo agoTNXPTonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)GlobeNewswireHORIZON is a potentially pivotal, randomized, double-blind, placebo-controlled Phase 2 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg as a first-line monotherapy in adults with MDD Primary
- 5mo agoTNXPTonix Pharmaceuticals to Attend BTIG Infectious Disease Day 2026GlobeNewswireBERKELEY HEIGHTS, N.J., June 11, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial-stage biotechnology company, today
- 5mo agoTNXPTonix Pharmaceuticals Secures Second Commercial Payer Agreement for TONMYA®, Expanding Total Commercial Coverage to ~52 Million U.S. LivesGlobeNewswireAgreement with second leading group purchasing organization (GPO), effective June 1, 2026, provides access to approximately 17 million additional U.S. commercial lives (10% of the ~177 million commercial lives in the
- 5mo agoTNXPTonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis of Opioid Use in Patients with Fibromyalgia at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual MeetingGlobeNewswireReal-world analysis of three years of closed claims data from Symphony Health, focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia Data demonstrate a
- 5mo agoTNXPTonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical ImmunologyGlobeNewswirePhase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection Phase 2 investigator-initiated study in
- 5mo agoTNXPTonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at The Professional Society for Health Economics and Outcomes Research (ISPOR) 2026 Annual MeetingGlobeNewswireReal-world analysis of three years of closed claims data from Symphony Health focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia Data underscore high
- 6mo agoTNXPTonix Pharmaceuticals to Present Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at ISPOR 2026GlobeNewswireBERKELEY HEIGHTS, N.J., May 14, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today
- 6mo agoTNXPTonix Pharmaceuticals to Participate in Two Investor Conferences in MayGlobeNewswireBERKELEY HEIGHTS, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today
- 6mo agoTNXPTonix Pharmaceuticals Reports First Quarter 2026 Financial Results and Operational HighlightsGlobeNewswireIn the first full quarter since launch, 2,145 healthcare providers prescribed TONMYA®, 3,588 patients initiated treatment, and ~5,400 prescriptions were filled Agreement signed in May with leading group purchasing
- 6mo agoTNXPTonix Pharmaceuticals Secures Commercial Payer Coverage for TONMYA®, Providing Access for ~35 Million U.S. PatientsGlobeNewswireAgreement with leading group purchasing organization (GPO) provides access to approximately 35 million U.S. commercial lives (20% of ~177 million commercial lives in the U.S.) TONMYA (cyclobenzaprine HCl sublingual
- 6mo agoTNXPTonix Pharmaceuticals Announces Presentation of Phase 1 Data and Plans for an Adaptive Phase 2 Field Study of TNX-4800 (anti-Borrelia OspA monoclonal antibody) for the Prevention of Lyme Disease at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins UniversityGlobeNewswireCompany on track to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA agreement Phase 2 field study expected to test a two-dose regimen of
- 6mo agoTNXPTonix Pharmaceuticals Presents Updates on Preclinical Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting 2026GlobeNewswireTNX-1700 (TFF2-albumin fusion protein) reversed aging-associated gastric inflammation and significantly attenuated tumor progression in aged gastric microenvironment in preclinical models TNX-1700 exhibited
- 7mo agoTNXPTonix Pharmaceuticals Announces Publication of Steady-State Pharmacokinetics of TONMYA® After 20 Days of Daily Dosing in the Peer-Reviewed Journal, Clinical Pharmacology in Drug DevelopmentGlobeNewswireTONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years TONMYA commercially launched in the U.S. in
- 7mo agoTNXPTonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026GlobeNewswireTNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics
- 7mo agoTNXPTonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) to Assess Potential for Treating Migraine and Craniofacial PainGlobeNewswireIntranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia
- 7mo agoTNXPTonix Pharmaceuticals Announces Presentations at World Vaccine Congress Washington 2026GlobeNewswireMonday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease Wednesday, April 1: Animal and in vitro studies on TNX-801 (horsepox,
- 8mo agoTNXPTonix Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational HighlightsGlobeNewswireTONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients,
- 8mo agoTNXPTonix Pharmaceuticals Presented Post Hoc Analyses of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in FibromyalgiaGlobeNewswireCompany launched TONMYA, approved by the FDA as a treatment for fibromyalgia, in November 2025 In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with
- 8mo agoTNXPTonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual MeetingGlobeNewswireTONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, was commercially launched in November 2025 Treatment with TONMYA provided statistically significant pain reduction in two
- 8mo agoTNXPTonix Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Studies of TONMYA™ and Prototype Formulations in the Journal Clinical Pharmacology in Drug DevelopmentGlobeNewswireCommercially launched in the U.S. in November 2025, TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime is the first new FDA-approved treatment for fibromyalgia in adults in more than 15
- 8mo agoTNXPTonix Pharmaceuticals to Present Poster on Tonmya™ at the 2026 American Academy of Pain Medicine PainConnect Annual MeetingGlobeNewswireCHATHAM, N.J., March 03, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial biotechnology company, announced today that a poster on
- 8mo agoTNXPTonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select MarketGlobeNewswireBERKELEY HEIGHTS, N.J., March 03, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today
- 8mo agoTNXPTonix Pharmaceuticals to Participate in Two Investor Conferences in MarchGlobeNewswireBERKELEY HEIGHTS, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today
- 9mo agoTNXPTonix Pharmaceuticals Presented Phase 3 RESILIENT Data on TONMYA™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2026 Non-Opioid Pain Therapeutics SummitGlobeNewswireTONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study Unique sublingual formulation designed for bedtime dosing bypasses first-pass metabolism, optimizing
- 10mo agoTNXPTonix Pharmaceuticals Announces Pricing of $20.0 Million Registered Direct OfferingGlobeNewswireCHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated commercial stage biotechnology company, today announced it has entered
- 10mo agoTNXPTonix Pharmaceuticals Announces Program Updates on Phase 2/3-Ready Long-Acting Monoclonal Antibody (mAb) Designed for Seasonal Prevention of Lyme Disease (TNX-4800)GlobeNewswireExploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive field study Expect to have investigational product of TNX-4800 (anti-Borrelia OspA mAb) available
- 11mo agoTNXPTonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain from Rutgers UniversityGlobeNewswireNon-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies
- 11mo agoTNXPTonix Pharmaceuticals Appoints Irina Ishak as General CounselGlobeNewswireCHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated commercial-stage biotechnology company today announced the appointment
- 11mo agoAMGNCTORFOLDSNGX+1Breakthrough Therapies Advance as Rare Disease Burden Intensifies Across Aging PopulationsGlobeNewswireAUSTIN, Texas, Dec. 04, 2025 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Chronic illnesses and rare disorders among older Americans represent a rapidly intensifying challenge for the U.S. healthcare system, with
- 11mo agoTNXPTonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive DisorderGlobeNewswireTonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026 More than 21 million US adults experience a major depressive episode each year
- 11mo agoTNXPTonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia TreatmentGlobeNewswireTONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years TONMYA is a unique, non-opioid, once-daily
- 1y agoTNXPTonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational HighlightsGlobeNewswireTonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash