Bay Area Lyme Foundation Raises $900,000 at LymeAid 2026, Presenting Inaugural Neil L. Spector, MD, Legacy Award and $300,000 in Emerging Leader Grants

Bay Area Lyme Foundation raised $900,000 at its annual LymeAid 2026 gala, featuring entertainment by Dana Carvey and Chris Isaak. The foundation presented its inaugural Neil L. Spector, MD, Legacy Award to Timothy Haystead, PhD, and distributed $300,000 in Emerging Leader Awards to researchers studying Lyme disease diagnostics and tick-borne infections. Bay Area Lyme Ventures expanded its portfolio with a new investment in Galaxy Diagnostics.

05/28/2026, 2:00 PM • GlobeNewswire

Tonix Pharmaceuticals to Present Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at ISPOR 2026

Tonix Pharmaceuticals announced a poster presentation at ISPOR 2026 featuring a retrospective U.S. real-world claims analysis of fibromyalgia patients using data from April 2021-April 2024. TONMYA (cyclobenzaprine HCl sublingual tablets), approved by the FDA on August 15, 2025, and commercially launched on November 17, 2025, is the first new prescription medicine for fibromyalgia in over 15 years. The company also reported strong Q1 2026 results with 2,145 healthcare providers prescribing TONMYA, 3,588 patients initiated treatment, and approximately 5,400 prescriptions filled.

05/14/2026, 7:00 AM • GlobeNewswire

Tonix Pharmaceuticals Announces Publication of Steady-State Pharmacokinetics of TONMYA® After 20 Days of Daily Dosing in the Peer-Reviewed Journal, Clinical Pharmacology in Drug Development

Tonix Pharmaceuticals announced the publication of pharmacokinetic data for TONMYA (cyclobenzaprine HCl sublingual tablets) in the peer-reviewed journal Clinical Pharmacology in Drug Development. The study demonstrated that TONMYA, the first new FDA-approved fibromyalgia treatment in over 15 years (approved August 2025, commercially launched November 2025), achieved steady-state pharmacokinetics at Day 20 with rapid absorption and higher bioavailability per dose compared to oral extended-release cyclobenzaprine. The sublingual formulation was generally safe and well-tolerated with no serious adverse events.

04/15/2026, 7:00 AM • GlobeNewswire

Tonix Pharmaceuticals to Present at BIO-Europe Spring 2026

Tonix Pharmaceuticals announced that CEO Seth Lederman will deliver a company presentation at BIO-Europe Spring 2026 in Lisbon on March 24, 2026. The presentation will highlight the company's commercial-stage biotechnology portfolio focused on CNS and immunology treatments, including TONMYA® for fibromyalgia (launched November 2025 with over 1,500 prescriptions), acute migraine products, and pipeline candidates in development.

03/18/2026, 4:58 PM • GlobeNewswire

Tonix Pharmaceuticals Presented Phase 3 RESILIENT Data on TONMYA™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2026 Non-Opioid Pain Therapeutics Summit

Tonix Pharmaceuticals presented Phase 3 RESILIENT trial data for TONMYA, a sublingual cyclobenzaprine formulation for fibromyalgia treatment. The drug demonstrated statistically significant reduction in pain (p<0.0001) and improvements in sleep disturbance, fatigue, and functional outcomes compared to placebo. TONMYA was well-tolerated with minimal weight and blood pressure effects, though oral cavity reactions were the most common adverse events. The drug was FDA-approved in August 2025 as the first new fibromyalgia prescription in over 15 years.

01/30/2026, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals received FDA clearance to proceed with a Phase 2 HORIZON study of TNX-102 SL, a potential new treatment for major depressive disorder, targeting 360 patients across 30 U.S. sites with planned enrollment in mid-2026.

11/24/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals launched TONMYA, the first FDA-approved fibromyalgia treatment in over 15 years, offering a novel, non-opioid, once-daily bedtime analgesic for the estimated 10 million adults suffering from the chronic pain disorder.

11/17/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals is collaborating with Massachusetts General Hospital to conduct a Phase 2 clinical trial of TNX-1500, a monoclonal antibody designed to prevent kidney transplant rejection with potentially reduced immunosuppressive drug side effects.

11/04/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals presented Phase 3 RESILIENT study data on Tonmya, demonstrating significant pain reduction in fibromyalgia patients with minimal side effects. The drug was FDA-approved in August 2025 and shows promise as a well-tolerated, non-opioid treatment.

10/27/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals presented preclinical data for TNX-801, a live virus vaccine candidate designed to protect against mpox and smallpox, demonstrating favorable safety, immunogenicity, and long-term protection across multiple animal models.

10/17/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals plans to initiate a Phase 2 clinical trial in 2026 for TNX-2900, an intranasal oxytocin treatment for Prader-Willi Syndrome in children and adolescents, targeting hyperphagia and behavioral challenges.

09/29/2025, 7:00 AM • GlobeNewswire

Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix Pharmaceuticals successfully completed a Pre-IND meeting with the FDA regarding TNX-102 SL for treating major depressive disorder, with plans to file an IND application in Q4 2025 and potentially develop a novel treatment targeting sleep-related symptoms of depression.

09/18/2025, 8:00 AM • GlobeNewswire

Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)

Tonix Pharmaceuticals has in-licensed TNX-4800, a long-acting monoclonal antibody designed to prevent Lyme disease through a single annual dose. The antibody targets Borrelia burgdorferi and aims to provide protection during the entire tick season in the U.S.

09/17/2025, 7:00 AM • GlobeNewswire

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

Tonix Pharmaceuticals received FDA approval for Tonmya, a first-in-class, non-opioid sublingual tablet for treating fibromyalgia in adults, marking the first new therapy for this condition in over 15 years.

08/15/2025, 3:44 PM • GlobeNewswire

Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators

Pharmaceutical companies are advancing treatments for rare diseases, with Soligenix leading efforts in developing HyBryte, a promising therapy for cutaneous T-cell lymphoma (CTCL), a rare skin cancer affecting older adults.

08/06/2025, 8:30 AM • Benzinga