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Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
For more information, visit Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals (TNXP) has appointed Gary Ainsworth as Vice President of Market Access, effective immediately. Ainsworth brings over two decades of industry experience, having previously served as Managing Director at Eversana Intouch and founder of Havas Gemini's Market Access Business Unit. The appointment comes as Tonix awaits FDA's decision on TNX-102 SL for fibromyalgia management, with a PDUFA date set for August 15, 2025.
The company's development portfolio focuses on CNS disorders, with TNX-102 SL as their priority candidate. The FDA previously granted Fast Track designation for this non-opioid, centrally-acting analgesic. Tonix also has other candidates in development, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company recently secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200.
Tonix Pharmaceuticals (TNXP) has announced its participation in two major investor conferences this January. CEO Seth Lederman will present at the 8th Annual Neuroscience Innovation Forum on January 12, 2025, delivering a company presentation at 11:15 a.m. PT and participating in a panel on neuropsychiatric treatments at 1:15 p.m. PT. Additionally, he will present at the 2025 Biotech Showcase on January 14, 2025, at 10:00 a.m. PT.
The company recently submitted an NDA for TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. Tonix's pipeline includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. They recently secured a DoD contract worth up to $34 million for developing TNX-4200, an antiviral agent. Their commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (TNXP) announced that the FDA has set a PDUFA goal date of August 15, 2025, for their TNX-102 SL marketing approval decision for fibromyalgia treatment. The drug, granted Fast Track designation in July 2024, is a non-opioid, centrally-acting analgesic that could become the first new fibromyalgia treatment in over 15 years.
The NDA submission is supported by two successful Phase 3 trials: RELIEF (completed December 2020) and RESILIENT (completed December 2023), both showing statistically significant pain reduction compared to placebo (p=0.010 and p=0.00005 respectively). TNX-102 SL demonstrated favorable tolerability with minimal adverse events, primarily consisting of temporary tongue numbness at the administration site.
Tonix Pharmaceuticals announced FDA acceptance of its New Drug Application (NDA) for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The drug, granted Fast Track designation in July 2024, could become the first new fibromyalgia treatment in over 15 years. The NDA is supported by two successful Phase 3 trials: RELIEF (completed December 2020) and RESILIENT (completed December 2023), both showing significant pain reduction compared to placebo (p=0.010 and p=0.00005 respectively).
TNX-102 SL was generally well tolerated, with tongue/mouth numbness being the most common side effect. The drug targets a condition affecting over 10 million U.S. adults, predominantly women. The FDA is expected to assign a PDUFA target action date and announce Priority Review status in the Day 74 Letter.
Tonix Pharmaceuticals (NASDAQ: TNXP) has submitted a new drug application (NDA) to the FDA for TNX-102 SL, a non-opioid treatment for fibromyalgia. The drug, which received Fast Track designation, targets sleep problems associated with fibromyalgia through a sublingual formulation of cyclobenzaprine hydrochloride.
In the recent RESILIENT phase 3 trial, TNX-102 SL demonstrated significant improvement in fibromyalgia pain (p-value=0.00005), sleep quality, fatigue, and overall symptoms. The global fibromyalgia market is projected to grow from $2.8 billion in 2024 to $4.13 billion in 2032. Currently, 85% of fibromyalgia patients fail first-line therapy, and 79% require multiple treatments.
FDA's decision on NDA acceptance is expected mid-December 2024, with potential approval by mid-August 2025.
Tonix Pharmaceuticals (TNXP) announces two strategic hires to support the launch of TNX-102 SL for fibromyalgia management. Bradley Raudabaugh, MBA, joins as VP Marketing with 25+ years experience, previously VP of Product Strategy at Axsome Therapeutics. Errol Gould, Ph.D., becomes VP Medical Affairs, bringing 25+ years in R&D and medical affairs. The company submitted an NDA for TNX-102 SL in October 2024, with FDA acceptance expected December 2024 and a decision in 2025. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and the first in a new class of analgesics.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at NobleCon20, Noble Capital Markets' Twentieth Annual Emerging Growth Equity Conference on December 3-4 in Boca Raton, Florida. The presentation is scheduled for Tuesday, December 3, 2024, at 12:00 p.m. ET.
The company highlighted its development portfolio, including TNX-102 SL for fibromyalgia management, which has FDA Fast Track designation and awaits an FDA decision on NDA acceptance in December. Other key developments include TNX-1300 for cocaine intoxication treatment, TNX-1500 for organ transplant rejection, and a recent $34 million contract with the U.S. DoD for developing TNX-4200 antiviral agents.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at the Winter 2024 Investor Summit Virtual on November 21, 2024, at 10:00 a.m. ET. The company, which focuses on pain management therapies and vaccines, highlighted its development portfolio including TNX-102 SL for fibromyalgia management, currently awaiting FDA review decision in December. The company also develops TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. Recently, Tonix secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200 antiviral agents. Their commercial subsidiary markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (TNXP) presented data from their Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia treatment at the ACR Convergence 2024. The study demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. The company submitted a New Drug Application to the FDA in October 2024, with a decision expected in 2025. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and the first in a new class of non-opioid analgesics targeting non-restorative sleep.
Tonix Pharmaceuticals (NASDAQ:TNXP) is marketing two non-oral migraine treatments: Zembrace SymTouch (sumatriptan autoinjector) and Tosymra (sumatriptan nasal spray), designed to provide relief in as little as 10 minutes. These products address limitations of oral medications, which can take 30-60 minutes to work and may be less effective during migraines due to gastroparesis. Clinical trials showed 17% of Zembrace users experienced relief within 10 minutes versus 5% with placebo, while Tosymra achieved 57% pain reduction at two hours compared to 21% with placebo. The company reported $11.3 million in trailing year sales for these migraine products.
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