Tonix Pharmaceuticals Holding CORP 8-K filings

Tonix Pharmaceuticals announces FDA approval for TONMYA, its fibromyalgia treatment, and provides updates on a diverse pipeline of drug candidates.

Tonix Pharmaceuticals announced the appointment of Ganesh Kamath as Head of Market Access and set the wholesale acquisition cost for its recently FDA-approved fibromyalgia drug, Tonmya.

Tonix Pharmaceuticals announced plans to initiate a Phase 2 clinical trial for TNX-2900, its magnesium-potentiated intranasal oxytocin formulation, for the treatment of Prader-Willi syndrome in 2026.

Tonix Pharmaceuticals announced positive feedback from the FDA on its Pre-Investigational New Drug meeting for TNX-102 SL in Major Depressive Disorder, planning an IND filing in Q4 2025.

Tonix Pharmaceuticals in-licenses worldwide rights to TNX-4800, a Phase 2/3-ready monoclonal antibody for seasonal Lyme disease prevention.

Tonix Pharmaceuticals Holding Corp. announced the U.S. Food and Drug Administration (FDA) has approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults.

Tonix Pharmaceuticals announced FDA approval of Tonmya (cyclobenzaprine HCl sublingual tablets) for adult fibromyalgia, marking the first new therapy in over 15 years.

Tonix Pharmaceuticals reported Q2 2025 financial results, highlighted progress on its fibromyalgia drug TNX-102 SL with an August 15, 2025 FDA PDUFA goal date, and maintained cash runway into Q3 2026.

Tonix Pharmaceuticals Holding Corp. disclosed preliminary second-quarter 2025 financial results, highlighting a significant reduction in net operating loss and an extended cash runway into the third quarter of 2026.

Tonix Pharmaceuticals Holding Corp. announced the launch of its 'Move Fibro Forward' campaign, aimed at raising awareness and providing support for individuals living with fibromyalgia.

Tonix Pharmaceuticals Holding Corp. is preparing for a potential Q4 2025 commercial launch of its fibromyalgia drug candidate TNX-102 SL, with an FDA PDUFA goal date set for August 15, 2025, and plans for a 70-90 person sales force.

Tonix Pharmaceuticals announced new preclinical findings for its TNX-801 vaccine candidate, demonstrating durable immunity and high attenuation, alongside a strategic shift to subcutaneous administration.

Tonix Pharmaceuticals announced the online publication of full positive results from its confirmatory Phase 3 RESILIENT trial for TNX-102 SL in fibromyalgia, reinforcing its New Drug Application with an FDA PDUFA target date of August 15, 2025.

Tonix Pharmaceuticals announced the publication of preclinical data in Cancer Cell journal, demonstrating that its investigational drug mTNX-1700 significantly improved survival and reduced metastases in animal models of gastric cancer when combined with anti-PD-1 immunotherapy.

Tonix Pharmaceuticals Holding Corp. announced positive Phase 3 clinical data for its investigational fibromyalgia treatment, TNX-102 SL, at the Annual European Congress of Rheumatology, with an FDA Prescription Drug User Fee Act (PDUFA) goal date set for August 15, 2025.

Tonix Pharmaceuticals Holding Corp. has appointed James Hunter, a seasoned commercial industry veteran, to its Board of Directors, strengthening its commercial strategy as it prepares for the potential launch of TNX-102 SL for fibromyalgia.

Tonix Pharmaceuticals Holding Corp. has entered into two new equity financing agreements, an At-The-Market (ATM) facility for up to $150 million and a purchase agreement for up to $75 million, to bolster its working capital and general corporate purposes.

Tonix Pharmaceuticals has initiated a Phase 2 trial to assess TNX-102 SL for reducing acute stress reaction and acute stress disorder, supported by a $3 million grant from the U.S. Department of Defense.

Tonix Pharmaceuticals announces the appointment of Joseph Hand as General Counsel and Executive Vice President of Operations, effective immediately, as the company prepares for potential FDA approval of TNX-102 SL for fibromyalgia.

Tonix Pharmaceuticals reported its Q1 2025 financial results, highlighting progress with TNX-102 SL for fibromyalgia and a cash runway into Q2 2026.

Tonix Pharmaceuticals held its annual shareholder meeting on May 8, 2025, where shareholders approved seven proposals, including the election of directors, ratification of the accounting firm, and authorization of a reverse stock split.

Tonix Pharmaceuticals presented preclinical data at the AACR 2025 Annual Meeting, demonstrating that a combination treatment involving TFF2 and an anti-PD1 antibody showed promise in reducing immunosuppression in gastric cancer models.

Tonix Pharmaceuticals announces preliminary Q1 2025 financial results, highlighting cash position and discontinuation of a Phase 2 study.

Tonix Pharmaceuticals presented data at the World Vaccine Congress highlighting the potential of its TNX-801 single-dose mpox vaccine, demonstrating protection and tolerability in preclinical studies.

Tonix Pharmaceuticals and Makana Therapeutics are partnering to study Tonix's TNX-1500 antibody in combination with Makana's human-compatible organs for treating organ failure.

Tonix Pharmaceuticals introduces TONIX ONE, a comprehensive digital platform designed to improve migraine management for patients through education, telehealth, and streamlined prescription access.

Tonix Pharmaceuticals announces the FDA will not require an Advisory Committee meeting for its TNX-102 SL New Drug Application (NDA) for fibromyalgia, keeping the drug on track for a potential launch in late 2025.

Tonix Pharmaceuticals reports its Q4 and full year 2024 financial results, highlighting progress with TNX-102 SL for fibromyalgia and other pipeline developments.

Tonix Pharmaceuticals receives a $50,000 grant to advance its TNX-801 vaccine candidate and unveils new data highlighting its safety and efficacy.

Tonix Pharmaceuticals has entered into an employment agreement with Siobhan Fogarty, appointing her as Chief Technical Officer with a base salary of $385,000, eligibility for bonuses, and equity compensation.