Tonix Pharmaceuticals Stock Hits New 52-Week Low: What's Driving The Action? - Tonix Pharmaceuticals (NAS Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) shares are trading lower Monday morning, hitting a fresh 52-week low as investors weigh a new SEC filing alongside a biotech pipeline update from late last week.

Tonix Pharmaceuticals Stock Hits New 52-Week Low: What's Driving The Action? Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) shares are trading lower Monday morning, hitting a fresh 52-week l...

#benzai #bzchart #News #TNXP #why #it's #moving #Movers #TNXP #News #Movers

Origin | Interest | Match

Tonix Pharmaceuticals Announces Presentations at World Vaccine Congress Washington 2026 Tonix Pharmaceuticals (Nasdaq: TNXP) announced presentations at World Vaccine Congress Washington 2026 in Washington, D.C., March 30–April 2, 2026. Highlights include a March 30 oral presentation of Phase 1 data on TNX-4800 for seasonal Lyme prevention and April 1 talks on TNX-801 and pox-based antigen delivery.Speakers include Mark S. Klempner, MD, Farooq Nasar, PhD, and Christopher Cooper, PhD, with session times and rooms listed for each presentation.

#TNXP Tonix Pharmaceuticals Announces Presentations at World Vaccine Congress Washington 2026

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights TONMYA™ (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, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative

#TNXP Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Presented Post Hoc Analyses of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in Fibromyalgia Tonix Pharmaceuticals (Nasdaq: TNXP) reported post hoc Phase 3 analyses of TONMYA (cyclobenzaprine HCl sublingual tablets) presented March 9–10, 2026. Key findings include rapid pain relief as early as Day 2, Week 14 primary endpoint superiority (LS mean diff -0.65, p<0.001), and favorable pooled benefit-risk metrics (NNT 7; NNH 26; LHH 3.7).The company noted TONMYA was generally well tolerated; oral cavity reactions were the most common adverse events.

#TNXP Tonix Pharmaceuticals Presented Post Hoc Analyses of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in Fibromyalgia

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 data for TONMYA (cyclobenzaprine HCl sublingual tablets) at the 2026 AAPM PainConnect Annual Meeting. The 14-week RESILIENT trial (n=457) showed statistically significant mean daily pain reduction and higher 30% responder rates versus placebo. TONMYA received FDA approval in August 2025 and launched commercially in November 2025. The drug was generally well tolerated; most adverse events were mild, self-limited oral cavity reactions that rarely caused withdrawal.

#TNXP Tonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Studies of TONMYA™ and Prototype Formulations in the Journal Clinical Pharmacology in Drug Development Commercially 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 years The sublingual TONMYA tablet containing a basifying agent achieved the

#TNXP Tonix Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Studies of TONMYA™ and Prototype Formulations in the Journal Clinical Pharmacology in Drug Development

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select Market Tonix Pharmaceuticals (Nasdaq: TNXP) announced approval to transfer its listing from the Nasdaq Capital Market to the Nasdaq Global Select Market, effective at market open on March 3, 2026, under the existing ticker TNXP.The company says the uplisting reflects compliance with higher financial and governance standards and may enhance visibility, liquidity and institutional access. Tonix is a commercial-stage biotech with recently approved TONMYA™ for fibromyalgia and marketed acute migraine products, plus multiple investigational CNS and immunology programs.

#TNXP Tonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select Market

www.stocktitan.net/news/TNXP/tonix-pharmace...

From gold and uranium to biotech and fintech, Zacks SCR highlights our analysts' best ideas for 2026: buff.ly/gewy0WC

#TRX #SBC #CBAT #TNXP #DYLLF #HITI #BGL #RADX

Tonix Pharmaceuticals Announces Pricing of $20.0 Million Registered Direct Offering Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial stage biotechnology company, today announced it has entered into a securities purchase agreement with Point72 for the purchase and sale of

#TNXP Tonix Pharmaceuticals Announces Pricing of $20.0 Million Registered Direct Offering

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Program Updates on Phase 2/3-Ready Long-Acting Monoclonal Antibody (mAb) Designed for Seasonal Prevention of Lyme Disease (TNX-4800) Tonix Pharmaceuticals (Nasdaq: TNXP) announced program updates for TNX-4800, a long-acting human monoclonal antibody targeting OspA for seasonal Lyme disease prevention.The company plans an FDA meeting in 2026 to explore Phase 2/3 options including a controlled human infection model (CHIM) and an adaptive Phase 2/3 field study. Tonix expects GMP investigational product to be available for clinical testing in early 2027. The company estimates ~70 million people in U.S. Lyme-endemic areas could potentially benefit. The release notes there are no currently marketed FDA-approved vaccines or prophylactics for Lyme disease and describes TNX-4800 as providing near-immediate immunity after one subcutaneous dose for seasonal protection.

#TNXP Tonix Pharmaceuticals Announces Program Updates on Phase 2/3-Ready Long-Acting Monoclonal Antibody (mAb) Designed for Seasonal Prevention of Lyme Disease (TNX-4800)

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain from Rutgers University Tonix Pharmaceuticals Holding

#TNXP Tonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain from Rutgers University

www.stocktitan.net/news/TNXP/tonix-pharmace...

#TNXP: Tonix Now a Commercial Stage Company Following the Launch of Tonmya™ buff.ly/2xePVRe

Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder Tonix Pharmaceuticals (NASDAQ: TNXP) announced FDA clearance of an IND to support clinical development of TNX-102 SL 5.6 mg for adults with major depressive disorder (MDD). The IND enables a potentially pivotal Phase 2 HORIZON study: a 6-week, randomized, double-blind, placebo-controlled trial enrolling ~360 patients at ~30 US sites, with primary endpoint of MADRS total score change at Week 6. Tonix plans to begin enrollment in mid-2026. Prior TNX-102 SL studies in fibromyalgia and PTSD showed signals of depressive-symptom improvement on BDI-II and MADRS. The program targets disturbed sleep associated with depression and the company reports prior tolerability data from fibromyalgia registrational studies.

#TNXP Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment Tonix Pharmaceuticals (Nasdaq: TNXP) announced that TONMYA™ (cyclobenzaprine HCl sublingual tablets) is now commercially available by prescription in U.S. pharmacies as of Nov 17, 2025. TONMYA is presented as a first‑in‑class, non‑opioid, once‑daily bedtime analgesic for adults with fibromyalgia and is the first FDA‑approved fibromyalgia treatment in more than 15 years.The FDA approved TONMYA on Aug 15, 2025 based on two double‑blind Phase 3 trials (nearly 1,000 patients) showing a significant reduction in daily pain at 14 weeks and a higher percentage achieving ≥30% pain improvement; three Phase 3 trials (> 1,400 patients) reported overall tolerability and listed common adverse events.

#TNXP Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights Tonix Pharmaceuticals (Nasdaq: TNXP) reported third-quarter 2025 results and operational highlights on Nov 10, 2025. Key commercial news: Tonmya (cyclobenzaprine HCl sublingual) received FDA approval as the first new fibromyalgia medicine in >15 years and is set to launch in November 2025 with a WAC established and field sales in place.Financials: $190.1M cash as of Sept 30, 2025 and a cash runway expected to fund operations into Q1 2027. Q3 product revenue was $3.3M versus $2.8M a year earlier. Q3 net loss was $32.0M (loss per share $3.59) with 8.92M weighted average shares outstanding.

#TNXP Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Presentation at BIO-Europe 2025 Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman, M.D. will present at BIO-Europe 2025 on November 4, 2025 at 3:00 p.m. CET in Presenting Company Theater 1 at the Vienna Congress and Convention Center.The presentation will overview Tonix’s strategy and pipeline, highlighting near-term clinical, regulatory, and commercial milestones. The company markets approved products including Tonmya for fibromyalgia and two acute migraine treatments, and it disclosed a DTRA contract for up to $34 million for TNX-4200. Management meetings can be requested via the BIO One-on-One Partnering system.

#TNXP Tonix Pharmaceuticals Announces Presentation at BIO-Europe 2025

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 RESILIENT data showing statistically significant pain reduction (p<0.0001) with Tonmya (cyclobenzaprine HCl sublingual tablets) versus placebo in adults with fibromyalgia.The 14-week, randomized, double-blind trial enrolled 456 intent-to-treat participants across 34 U.S. sites. Tonmya also produced meaningful improvements in sleep, fatigue, and fibromyalgia symptoms/function, and exploratory analyses showed sexual function gains in female participants.Tonmya was FDA approved on August 15, 2025. Safety findings included low adverse event–related discontinuations (6.1% on Tonmya vs 3.5% placebo) and mostly mild oral mucosal reactions; labeled risks include embryofetal toxicity and serotonin syndrome drug interactions.

#TNXP Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025 Tonix Pharmaceuticals (Nasdaq: TNXP) presented preclinical data for its investigational live, attenuated vaccine candidate TNX-801 at World Vaccine Congress–Europe 2025 (Oct 14–16, 2025).Presentations reported that a single dose of TNX-801 produced durable immunogenicity for at least 14 months, elicited strong neutralizing antibodies, and protected non-human primate, rabbit, and murine models from clinical disease and mortality after mpox challenge. TNX-801 was described as well tolerated across percutaneous, subcutaneous, and intramuscular routes. The company said the data support advancing TNX-801 toward clinical development and noted interest in evaluating a microneedle patch delivery option.

#TNXP Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation 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

#TNXP Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of TNX-2900 (Intranasal Potentiated Oxytocin) in 2026 Tonix Pharmaceuticals (NASDAQ:TNXP) has announced plans to initiate a Phase 2 clinical trial for TNX-2900, its intranasal potentiated oxytocin treatment for Prader-Willi Syndrome (PWS), in 2026. The trial will evaluate the drug in children and adolescents aged 8-17.5 years.TNX-2900 has received both Orphan Drug and Rare Pediatric Disease designations from the FDA, making it eligible for a Priority Review Voucher upon approval. The drug features a magnesium-potentiated formulation designed to improve receptor binding and reduce dose-related inconsistencies. The Phase 2 study will be randomized, double-blind, and placebo-controlled, with participants receiving either TNX-2900 at three different dose levels or placebo for 12 weeks.PWS affects 1 in 10,000 to 1 in 30,000 births and is the leading cause of life-threatening childhood obesity. The trial's primary endpoint will measure changes in hyperphagia severity using the HQ-CT questionnaire, with secondary objectives assessing behavior, caregiver burden, and quality of life measures.

#TNXP Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of TNX-2900 (Intranasal Potentiated Oxytocin) in 2026

www.stocktitan.net/news/TNXP/tonix-pharmace...

#TNXP: Tonmya™ Approved by FDA… buff.ly/zkg2hHJ

JUST IN: ( NASDAQ: #TNXP ) Tonix Pharmaceuticals Announces FDA Approval of Tonmya(TM) (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

First New Fibromyalgia Drug in 15 Years: Tonix's Tonmya Approved for 10M+ US Patients After Strong Trial Results Tonmya, a non-opioid sublingual tablet, showed significant pain reduction in 1,000+ patient trials. Targets 10M+ US adults with fibromyalgia. Commercial launch set for Q4 2025.

#TNXP Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q2 2025 financial results and operational highlights, with key focus on their lead candidate TNX-102 SL for fibromyalgia, which has an FDA PDUFA date of August 15, 2025. The company reported $125.3 million in cash and cash equivalents as of June 30, 2025.Q2 2025 financial results showed net product revenue of $2.0 million and a net loss of $28.3 million ($3.86 per share). The company's cash runway is expected to extend into Q3 2026, supported by recent equity offerings that raised $51.5 million in net proceeds.Notable developments include the company's addition to the Russell 3000® and Russell 2000® Indexes, publication of positive Phase 3 RESILIENT trial results in Pain Medicine, and progress across their CNS and immunology pipeline, including TNX-1500 and TNX-801.

#TNXP Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights

www.stocktitan.net/news/TNXP/tonix-pharmace...

#TNXP: 2Q25 Financial Update and Deep Dive Into TNX-1500… buff.ly/24LNtmt

Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025 Tonix Pharmaceuticals (Nasdaq: TNXP) presented new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025. The vaccine shows promising characteristics including up to 100,000-fold less virulence than traditional smallpox vaccines while providing robust protection. Key findings demonstrate that subcutaneous administration offers equivalent protection to traditional percutaneous delivery.TNX-801 demonstrated strong binding and neutralizing antibody responses across multiple animal species, with macaques showing 100% survival against lethal mpox challenge without lesions. The vaccine provided protection lasting over 14 months in rabbit models. The company plans to advance TNX-801 to clinical trials using subcutaneous delivery, positioning it as a potential single-dose solution for mpox and smallpox prevention.

#TNXP Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025

www.stocktitan.net/news/TNXP/tonix-pharmace...

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 Tonix Pharmaceuticals (NASDAQ:TNXP) has published results from its Phase 3 RESILIENT trial of TNX-102 SL for fibromyalgia in Pain Medicine journal. The trial demonstrated statistically significant improvement in reducing fibromyalgia pain compared to placebo, with a 1.8-point reduction versus 1.2-point for placebo on the daily pain scale.The study, involving 457 adults across 33 U.S. sites, showed significant improvements across all six key secondary endpoints. TNX-102 SL was generally well-tolerated, with mild side effects. The FDA's PDUFA decision date is set for August 15, 2025, and if approved, it would be the first new fibromyalgia treatment in over 15 years.

#TNXP 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

www.stocktitan.net/news/TNXP/tonix-pharmace...

Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025 Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Sina Bavari will present new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025 in Vienna, Austria. TNX-801 is a minimally replicative, attenuated live virus vaccine that has shown promising preclinical results, demonstrating protection against mpox and other orthopoxviruses after a single dose.The presentation, scheduled for July 10th at 11:20am GMT+2, will highlight TNX-801's safety, immunogenicity, and efficacy findings. The vaccine has demonstrated durable protection and good tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at high doses. TNX-801 also serves as a platform that can deliver multiple protective antigens against diverse viral pathogens. Additionally, Tonix has a $34 million contract with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.

#TNXP Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025

www.stocktitan.net/news/TNXP/tonix-pharmace...