Welcome to our dedicated page for Tonix Pharmaceuticals Holding news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceuticals Holding stock.
Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced company executives will present and join a panel at the World Vaccine Congress–Europe 2025 in Amsterdam on October 14–16, 2025.
Dr. Sina Bavari will present on Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine on October 15, 2025 at 2:15 p.m. CEST. Dr. Bavari and Dr. Zeil Rosenberg will join a panel titled Can We Enhance Vaccine Effectiveness? Mpox (Monkeypox) as a Model on October 14, 2025 at 11:30 a.m. CEST.
A copy of the presentation will be posted under the Presentations tab at the company's investor website following the conference. The release also summarizes Tonix's marketed product Tonmya and its infectious disease pipeline including TNX-801 and related programs.
Tonix Pharmaceuticals (Nasdaq: TNXP) has appointed Ganesh Kamath as Head of Market Access, effective September 29, 2025. This appointment strengthens the company's commercial leadership team ahead of the Q4 2025 launch of Tonmya™, their recently FDA-approved treatment for fibromyalgia in adults.
Kamath brings over 25 years of experience in market access, pricing, and commercial operations from positions at Bayer HealthCare, Hutchmed International, and CuriaGlobal. The appointment follows the FDA approval of Tonmya on August 15, 2025, marking the first new fibromyalgia therapy approval in more than 15 years.
Tonix's portfolio includes marketed migraine treatments and development candidates across CNS disorders, immunology, rare diseases, and infectious diseases, including a $34 million DoD contract for TNX-4200 development.
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.
Tonix Pharmaceuticals (NASDAQ:TNXP) announced successful completion of a Pre-IND meeting with the FDA regarding TNX-102 SL for treating major depressive disorder (MDD). The company plans to file an IND application in Q4 2025 and pursue a supplemental new drug application (sNDA) to expand TNX-102 SL's indication to include MDD.
TNX-102 SL, already FDA-approved for fibromyalgia under the brand name Tonmya™, showed promising results in improving depression symptoms during the Phase 3 RESILIENT study. The drug's unique formulation allows for transmucosal absorption, bypassing first-pass hepatic metabolism, and requires significantly lower doses compared to traditional tricyclic antidepressants.
Tonix Pharmaceuticals (Nasdaq: TNXP) has announced the in-licensing of worldwide rights to TNX-4800, a long-acting human monoclonal antibody designed for seasonal prevention of Lyme disease. The antibody targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease.
The treatment, developed by UMass Chan Medical School researchers, requires just one subcutaneous dose in Spring to provide protection through Fall. TNX-4800 has shown positive Phase 1 results with safety, tolerability, and linear pharmacokinetic relationships. The potential market includes approximately 70 million people living in Lyme disease endemic areas in the U.S.
TNX-4800 works by blocking Borrelia maturation in infected tick midguts, offering immediate immunity without requiring the recipient's immune system to generate antibodies. The company plans to advance the treatment through additional clinical trials toward a Biologics Licensing Application (BLA).
Tonix Pharmaceuticals (NASDAQ:TNXP) presented clinical data for Tonmya™, its recently FDA-approved treatment for fibromyalgia, at PAINWEEK 2025. The drug, approved on August 15, 2025, represents the first new FDA-approved fibromyalgia treatment in over 15 years.
The presentation included results from two pivotal Phase 3 trials (RELIEF and RESILIENT) demonstrating that Tonmya significantly reduced fibromyalgia pain compared to placebo. The drug showed consistent improvements across core symptoms, including widespread pain, sleep disturbance, and fatigue, while maintaining a favorable tolerability profile.
Tonmya works by targeting nonrestorative sleep through receptor antagonism that regulates sleep architecture. The company expects commercial availability in Q4 2025.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference on September 4, 2025, at 1:35 PM ET. The event will be webcast and available for replay on the company's investor relations website.
The press release highlights Tonix's recent milestone of receiving FDA approval for Tonmya™, their first-in-class, non-opioid analgesic for fibromyalgia - the first new prescription medicine approval for this condition in over 15 years. The company's pipeline includes developments in CNS disorders, immunology, and infectious diseases, including TNX-4200, supported by a $34 million DoD contract.
Tonix Pharmaceuticals (Nasdaq: TNXP) has received FDA approval for Tonmya™, a groundbreaking treatment for fibromyalgia in adults - the first new therapy approved in over 15 years. This non-opioid, sublingual tablet is designed for once-daily bedtime use with rapid bloodstream absorption.
Two pivotal Phase 3 clinical trials involving nearly 1,000 patients demonstrated significant pain reduction compared to placebo at 14 weeks. The drug showed favorable tolerability across three Phase 3 trials with over 1,400 patients. Commercial launch is expected in Q4 2025, targeting a market of over 10 million U.S. adults affected by fibromyalgia.
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.
Tonix Pharmaceuticals (Nasdaq: TNXP) has launched the "Move Fibro Forward" campaign through its commercial subsidiary, Tonix Medicines, Inc. The initiative aims to raise awareness and provide support for individuals affected by fibromyalgia, a condition that has not seen new FDA-approved treatments in over 15 years.
The campaign represents Tonix's commitment to the fibromyalgia community, focusing on validating patient experiences and providing educational resources. The initiative is supported by the Fibromyalgia Association, emphasizing the importance of visibility and support for those affected by this debilitating condition.