BERKELEY 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 announced that it will host a conference call and webcast to report second quarter 2026 financial results and operational highlights on Monday, August 10, 2026, at 8:30 a.m. ET. To listen to the conference call, register at this link. To view the webcast, register at this link. A replay will be a

Data show clade IIb from 2022 outbreak is 100 to 100,000-fold less virulent than clade IIa from 2003 outbreak

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

Related Stocks: TNXP,

Related Stocks: TNXP, IVV, WBD, NVDA, NSC, SPYM,

Tonix Pharmaceuticals announces management participation at BTIG Infectious Disease Day 2026, with a spotlight on its growing clinical portfolio and imminent Phase 2 trials for a variety of unmet medical needs. The article delves into Tonix’s diversified development strategy and highlights their forward-looking R&D priorities.

BERKELEY 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 announced that the management team will participate in 1x1 meetings at BTIG’s Infectious Disease Day 2026, held virtually on June 16, 2026.

Related Stocks: TNXP,

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP – Get Free Report) CEO Seth Lederman purchased 5,000 shares of the business’s stock in a transaction on Tuesday, June 9th. The shares were bought at an average cost of $11.79 per share, with a total value of $58,950.00. Following the acquisition, the chief executive officer directly owned 9,005 shares […]

No description provided for this story.

Tonix announced a second commercial payer agreement for Tonmya, its fibromyalgia treatment.

No description provided for this story.

No description provided for this story.

Phase 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

By David Bautz, PhD NASDAQ: TNXP READ THE FULL TNXP RESEARCH REPORT Business Update Tonmya™ Update Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is continuing the commercial launch of Tonmya® following its approval in November 2025. Sales metrics for the first quarter of 2026, which is the first full quarter of sales since the launch, include: 2,145 unique healthcare providers prescribed

maverick_1

Tonix Pharmaceuticals is set to share data analyzing real-world fibromyalgia patients in the U.S. at ISPOR 2026, building on TONMYA’s status as the first new fibromyalgia treatment approved in over 15 years. Here’s how this presentation may impact both the company’s clinical outlook and investor interest.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

No description provided for this story.

BERKELEY 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 announced a poster presentation at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, being held May 17-20, 2026, in Philadelphia, Pennsylvania. The retrospective cohort study utilized U.S. claims data from April 2021-April 2024 to analyze adults with fibro

No description provided for this story.

Related Stocks: TNXP,

No description provided for this story.

No description provided for this story.

No description provided for this story.

In 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 organization (GPO) that provides access to TONMYA for approximately 35 million U.S. commercial lives Expect to initiate adaptive Phase 2 field study for the prevention of Lyme disease in the U.S. in the first half of 2027 for TNX-4800, pending FDA agreement Approximately $185.5 million in cash and cash equivalents as of March 31, 2026 BERKELEY HEIGHTS, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced financial results for the quarter ended March 31, 2026, and provided an overview of recent operational highlights. "TONMYA is the first new fibromyalgia medicine in 15 years," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "TONMYA is a non-opioid analgesic designed for bedtime administration and long-term use by adults. Since launch in November 2025, TONMYA has shown growth in prescriptions, new writers, refills, and patient access. Our first managed care partnership was announced in May, providing access to approximately 35 million U.S. commercial lives. We will continue engagement with commercial and government payers to expand patient access. Our focus remains on operational excellence across sales, marketing, medical affairs, and market access to educate and deliver on TONMYA's differentiated potential." Dr. Lederman continued, "We also continue to meaningfully advance our mid-stage clinical programs and our earlier-stage pipeline. For TNX-4800, our investigational long-acting borreliacidal, human monoclonal antibody targeting OspA on Borrelia burgdorferi, which causes the majority of Lyme disease in the U.S., we announced positive Phase 1 data and plans for an adaptive Phase 2 field study in 2027, pending FDA agreement. We look forward to our scheduled Type C meeting with the FDA early in the third quarter of 2026 to discuss the study. We believe TNX-4800 offers several advantages over vaccines in development, including onset of protection within two days and a simpler two-dose regimen with a second booster dose two months after the first. We also expect to begin our Phase 2 study of TONMYA for the treatment of Major Depressive Disorder (MDD) mid-year. Our other programs across CNS, infectious disease, immunology, and rare disease remain well positioned for near-term milestones." Commercial Updates TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults On November 17, 2025, TONMYA became commercially available, following U.S. FDA approval in August 2025 for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical studies of nearly 1,000 patients that demonstrated durable and statistically significant reduction in daily pain scores compared to placebo. There are now approximately 100 TONMYA sales reps in the field. In the first quarter of 2026, the first full quarter since launch, key metrics include: 2,145 unique healthcare providers prescribed TONMYA to patients. 3,588 unique patients initiated treatment with TONMYA. Approximately 5,400 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue. For the period beginning November 17, 2025, through April 24, 2026, cumulative key metrics include: More than 2,700 unique healthcare providers have prescribed TONMYA to patients. Approximately 5,618 unique patients have initiated treatment with TONMYA. For the period beginning November 17, 2025, through May 1, 2026, cumulative key metrics include: Approximately 11,016 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel. Repeat prescriber and patient refill trends are encouraging. The Company is prioritizing engagement with commercial payers, Medicare, and Medicaid to increase access: In May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients (20% of ~177 million commercial lives in the U.S.) To date, TONMYA is covered under Medicaid in 38 states, for approximately 55 million lives, representing 73% of the roughly 75 million Medicaid lives. Tonix has a robust patient access program and support services in place, including a TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization. To educate healthcare providers (HCPs), the Company held a multidisciplinary dialogue about TONMYA via a national webcast. Tonix also launched a national speaker training program with approximately 100 HCPs to maximize peer-to-peer speaker programs expected to occur across target specialties and regions this year. As part of a commitment to continued clinical evidence generation and education, Tonix presented clinical data on TONMYA at the 8th International Congress on Controversies in Fibromyalgia, 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, and 2026 Non-Opioid Pain Therapeutics Summit. The Company also published two articles in the peer-reviewed journal, Clinical Pharmacology in Drug Development. Key Product Pipeline Candidates: Recent Highlights Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD; remains on track to initiate mid-year 2026 In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026. TNX-102 SL in Phase 2 development for the treatment of acute stress disorder (ASD) and acute stress reaction (ASR) The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) study is being conducted by the University of North Carolina under an investigator-initiated IND. The OASIS study examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026. TNX-1300 (double-mutant cocaine esterase) for cocaine intoxication; Phase 2-program has Breakthrough Therapy designation from the FDA, with no products on the market for this indication The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2a study has been completed). TNX-1900 (intranasal potentiated oxytocin): in development for several CNS disorders TNX-1900 is currently being studied in four Phase 2 and one Phase 1 investigator-initiated studies. The Phase 2 investigator-initiated studies include binge-eating disorder (Massachusetts General Hospital, "MGH"), adolescent obesity (MGH), bone health in autism (MGH and University of Virgina), and arginine vasopressin deficiency (MGH). In March 2026, Tonix announced the dosing of the first participant in a Phase 1 investigator-initiated pharmacodynamic study with Erasmus University of TNX-1900 in healthy female volunteers, using capsaicin and electrical stimulation to model trigeminal neurovascular reactivity. Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the U.S., which has no FDA-approved vaccines or prophylactics In March 2026, Tonix presented Phase 1 data at the World Vaccine Congress Washington 2026 and announced plans to initiate an adaptive Phase 2 field study in the first half of 2027, pending FDA agreement. The Company also presented Phase 1 data in April 2026 at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University. TNX-4800 demonstrated encouraging safety, tolerability, pharmacokinetics, and immunogenicity, with serum TNX-4800 measurable at the earlier sampling time of 48 hours and no significant clinical or laboratory safety signals. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. In April 2026, the Company announced it expects to lead a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 subcutaneous (SC) in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose. In Apr

No description provided for this story.

Tonix Pharmaceuticals has secured commercial payer coverage for TONMYA, its newly FDA-approved fibromyalgia treatment, granting access to around 35 million U.S. patients. This major milestone could reshape the landscape for fibromyalgia care, addressing a critical need among patients dissatisfied with existing therapies.

No description provided for this story.

No description provided for this story.

No description provided for this story.

TD Cowen raised Tonix Pharmaceuticals to a "strong-buy" rating in a report on Tuesday.

Tonix Pharmaceuticals (NASDAQ:TNXP) will be releasing its Q1 2026 earnings before the market opens on Monday, May 11. (View Earnings Report at

No description provided for this story.

Related Stocks: TNXP,

No description provided for this story.

Company 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 TNX-4800 subcutaneous with an initial Spring dose followed by a Summer booster two months later; the primary endpoint is Lyme disease prevention for six months TNX-4800 is expected to provide protection against Lyme disease within two days of the first dose for the peak of the U.S. Lyme season BERKELEY HEIGHTS, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 (formerly known as mAb 2217LS)1,2 for the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is expected to initiate in the first half of 2027, pending FDA agreement. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025. TNX-4800 is a long-acting bactericidal (or borreliacidal), human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the spirochete bacteria that causes 99.9% of Lyme disease cases in the U.S.3,4 TNX-4800 was engineered to include a crystallizable fragment (Fc) domain that provides an extended half-life. Tonix is developing TNX-4800 for the prevention of Lyme disease during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease. "We plan to initiate an adaptive Phase 2 field study in the first half of 2027 pending FDA agreement," said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. "We intend to test a two-dose regimen of TNX-4800, with the first dose administered in the Spring and a second dose administered two months later, for protection against Lyme disease for six months following the initial dose as the primary endpoint. We believe the Phase 1 pharmacokinetic (PK) data support this study design. Each fixed subcutaneous (SC) dose is expected to provide exposures comparable to the 5 mg/kg SC dose evaluated in Phase 1. We have scheduled a meeting with the FDA early in the third quarter of 2026. We look forward to advancing the clinical investigation of TNX-4800 as we strive to overcome the major public health challenges posed by Lyme disease." Dr. Lederman continued, "As a long-acting monoclonal antibody that offers passive immunity against the Lyme-causing bacteria within two days, we believe TNX-4800 offers significant advantages over the alum-based combination multi-OspA subunit vaccine in late-stage clinical development. Lyme disease vaccines that elicit antibodies to OspA take more than six months to offer protection and require complex immunization schedules which are obstacles to adherence. A previously approved alum-based OspA subunit vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization schedule. We believe TNX-4800's differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease." A copy of the poster is available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com. Adaptive Phase 2 Field Study PlansPending FDA agreement, the Company plans to initiate an adaptive field study in the first half of 2027. The Company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in ...Full story available on Benzinga.com

Wall Street Zen cut shares of Tonix Pharmaceuticals from a "hold" rating to a "sell" rating in a research report on Sunday.