Tonix Pharmaceuticals Holding Corp. - Common Stock (TNXP)

Tonix Pharmaceuticals (NASDAQTNXP) has appointed Gary Ainsworth as Vice President, Market Access, as the company prepares for the potential FDA approval of TNX-102 SL, a non-opioid analgesic for fibromyalgia, with a PDUFA decision date set for Aug. 15, 2025. Ainsworth brings extensive experience from roles at Eversana Intouch, Havas Gemini, Baxter International, Roche Laboratories, and Sanofi, where he developed market access strategies and payer-focused resources. His appointment strengthens Tonix’s commercial strategy to support the launch of TNX-102 SL, aimed at addressing the needs of fibromyalgia patients, a condition primarily affecting women.

Tonix Pharmaceuticals (NASDAQTNXP), a biopharmaceutical company focused on marketed products and development candidates, announced its participation in two investor conferences in January 2025. Seth Lederman, M.D., President and CEO, will present and join a panel discussion at the 8th Annual Neuroscience Innovation Forum on Jan. 12 at the Marines Memorial Club in San Francisco. He will also present at the 2025 Biotech Showcase on Jan. 14 at the Hilton San Francisco Union Square. Replays of the presentations will be available on Tonix’s website under the IR Events tab. Interested investors can arrange meetings through the respective conference coordinators.

Tonix Pharmaceuticals (NASDAQTNXP) announced that the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of Aug. 15, 2025, for a decision on TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. This non-opioid analgesic demonstrated significant pain reduction in two Phase 3 trials—RELIEF and RESILIENT—while maintaining favorable tolerability. Previously granted Fast Track designation, TNX-102 SL aims to address the unmet needs of fibromyalgia patients, offering a potential new class of treatment for this chronic condition that affects over 10 million U.S. adults.

Tonix Pharmaceuticals (NASDAQTNXP) announced that the U.S. FDA has accepted its New Drug Application (“NDA”) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, following its Fast Track designation in July 2024. The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, where TNX-102 SL met its primary endpoint of significantly reducing daily pain compared to placebo. The drug was generally well-tolerated, with the most common adverse event being temporary tongue or mouth numbness. Tonix aims to address the unmet needs of over 10 million U.S. adults with fibromyalgia, as existing treatments have left patients at risk for opioid prescriptions. The company anticipates potential approval in 2025, with commercial preparations underway alongside its current migraine treatments, Zembrace® SymTouch® and Tosymra®.

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

Tonix Pharmaceuticals (NASDAQTNXP) has submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for TNX-102 SL, its non-opioid drug candidate for managing fibromyalgia. With the global fibromyalgia market projected to grow from $2.8 billion in 2024 to $4.13 billion by 2032, the company anticipates the FDA’s decision on NDA acceptance by mid-December 2024. If accepted, the FDA could decide on approval in 2025, positioning TNX-102 SL for market entry as early as next year. Tonix highlighted the unmet need in fibromyalgia treatment, noting that 85% of patients fail first-line therapy, and 79% require multiple therapies.

Tonix Pharmaceuticals (NASDAQTNXP) has strengthened its leadership team with the appointments of Bradley Raudabaugh as Vice President of Marketing and Errol Gould, Ph.D., as Vice President of Medical Affairs, to prepare for the anticipated launch of TNX-102 SL for fibromyalgia. Raudabaugh brings extensive expertise from leading product launches at Axsome Therapeutics and other top pharmaceutical companies, while Dr. Gould offers over 25 years of experience in medical affairs and research across neurology, pain, and sleep therapeutics. These strategic hires aim to enhance Tonix’s commercial strategies and build its reputation in the medical community as the company awaits the FDA decision on TNX-102 SL in 2025.

Tonix Pharmaceuticals (NASDAQTNXP) announced that Chief Operating Officer Jessica Morris will present and host investor meetings at NobleCon20, Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference, on Dec. 3-4, 2024, in Boca Raton, Florida. The company’s presentation is scheduled for December 3 at 12 p.m. ET in Presentation Room 3 at the Florida Atlantic University COBEE Complex. A video webcast of the presentation will be available the following day on the Tonix Pharmaceuticals website, NobleCon’s conference site, and the Channelchek investor portal.

Tonix Pharmaceuticals (NASDAQTNXP) announced that Chief Operating Officer Jessica Morris will present at the Winter 2024 Investor Summit Virtual on Thursday, Nov. 21, 2024, at 10 a.m. ET. Investors interested in meeting with the company’s management can coordinate through the conference organizer. A live webcast of the presentation will be available on the Tonix website under the IR Events tab.

Tonix Pharmaceuticals (NASDAQTNXP) presented data at the ACR Convergence 2024 Annual Meeting showcasing the success of its Phase 3 RESILIENT study for TNX-102 SL, a sublingual cyclobenzaprine treatment for fibromyalgia. The study met its primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005), and demonstrated statistically significant improvements in sleep quality, fatigue, global ratings, and overall fibromyalgia symptoms across six secondary endpoints. TNX-102 SL was well tolerated with no new safety concerns. Following the submission of a New Drug Application (“NDA”) to the FDA in October 2024, Tonix anticipates an FDA decision in 2025, potentially introducing the first new fibromyalgia treatment in 15 years.

Tonix Pharmaceuticals (NASDAQTNXP) is at the cutting edge of developing innovative therapies that address unmet needs in various medical fields, including neurology, immunology and infectious diseases. The company will be presenting alongside world-class headliners such as Zack Kass, former Head of Go-To-Market at OpenAI where ChatGPT was created, and “Shark Tank” stars Kevin O’Leary, Robert Herjavec, and Daymond John.

Tonix Pharmaceuticals (NASDAQTNXP) through its subsidiary Tonix Medicines, has introduced two fast-acting migraine treatments, Zembrace® SymTouch® (sumatriptan autoinjector) and Tosymra® (sumatriptan nasal spray), aimed at providing relief within 10 minutes. Designed to meet the urgent needs of migraine sufferers who may experience attacks without warning, these non-oral options cater to individuals who wake with migraines or lack early warning signs. With this addition, Tonix expands its focus on central nervous system treatments, offering quicker relief options for those who need immediate intervention.

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

Tonix Pharmaceuticals (NASDAQTNXP) has published new data in mSphere demonstrating that TNX-801, a recombinant chimeric horsepox virus vaccine, shows significantly reduced virulence compared to traditional vaccinia vaccines and provides protection against Clade Ia monkeypox in preclinical studies. With the World Health Organization declaring new public health emergencies for Clade Ib and IIb mpox, Tonix is positioning TNX-801 as a single-dose vaccine candidate aimed at durable protection against these outbreaks. Tonix is advancing TNX-801’s development with FDA feedback, collaborations for large-scale manufacturing, and planned clinical trials in Kenya, believing its vaccine could offer broad, long-lasting immunity against both mpox and smallpox.

Tonix Pharmaceuticals (NASDAQTNXP) reported its third-quarter 2024 financial results, highlighting the submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL, a potential treatment for fibromyalgia. The FDA granted TNX-102 SL Fast Track designation in the third quarter of 2024, aiming to expedite the review process for this non-opioid analgesic. Additionally, Tonix is progressing with TNX-801, a potential mpox vaccine, aligning with the World Health Organization’s target product profile for mpox vaccines. The company also announced the enrollment of the first patient in the Phase 2 CATALYST study of TNX-1300 for cocaine intoxication treatment. These developments underscore Tonix’s commitment to advancing treatments for central nervous system disorders and infectious diseases.

Tonix Pharmaceuticals (NASDAQTNXP) has entered a research agreement with the Kenya Medical Research Institute (KEMRI) to initiate a Phase I clinical study of its TNX-801 vaccine candidate in Kenya. The study will evaluate the safety, tolerability, and immunogenicity of TNX-801, a horsepox-based live virus vaccine designed to protect against mpox and smallpox. Tonix will sponsor the trial, while KEMRI will oversee its execution. This development follows promising preclinical data for TNX-801 and aligns with the World Health Organization’s preferred product profile for mpox vaccines, highlighting its potential as a single-dose vaccine with durable protection that can be scaled for global distribution.

Tonix Pharmaceuticals (NASDAQTNXP) presented preclinical data on its novel mpox vaccine candidate, TNX-801, at the World Vaccine Congress-Europe 2024. The presentation underscored the vaccine’s robust tolerability and immune protection with single-dose efficacy against a monkeypox challenge, even in immunocompromised animals. TNX-801, based on an attenuated live horsepox virus, demonstrated an inability to spread in blood or tissues and showed potential to reduce transmission. Aligned with the World Health Organization’s target for mpox vaccines, TNX-801 offers promising characteristics like single-dose durability and stability, positioning it as a compelling option for mpox prevention globally.

Tonix Pharmaceuticals (NASDAQTNXP), a biopharmaceutical company advancing treatments across multiple therapeutic areas, announced that CEO Seth Lederman, M.D., will present at the BIO-Europe® conference on Monday, Nov. 4, 2024, at 1 p.m. CET in Stockholm, Sweden. The presentation is set to highlight Tonix’s developments and strategic direction.

Tonix Pharmaceuticals (NASDAQTNXP) announced that Jessica Morris, the company’s Chief Operating Officer, will present at the ThinkEquity Conference on Wednesday, Oct. 30, 2024, at 9:30 a.m. ET at the Mandarin Oriental in New York City. Alongside her presentation, Morris will also engage in investor meetings during the event. A webcast of her presentation will be accessible on the Tonix website under the IR Events section.

Tonix Pharmaceuticals (NASDAQTNXP) announced that Zeil Rosenberg, M.D., M.P.H., the company’s Executive Vice President, Medical, will present at the World Vaccine Congress Europe in Barcelona on Oct. 30, 2024. The presentation will highlight a novel, single-dose, live, attenuated, minimally replicating Mpox vaccine. Details of the presentation will be available on Tonix’s website after the conference.

Tonix Pharmaceuticals (NASDAQTNXP) has received its first payment from the Defense Threat Reduction Agency (DTRA), part of the U.S. Department of Defense, to support the development of small molecule broad-spectrum antiviral agents. The five-year contract, worth up to $34 million, aims to improve the medical readiness of military personnel in biological threat environments. The funding will accelerate Tonix’s antiviral research, focusing on compounds targeting CD45 to create effective countermeasures against viral infections. The company will leverage its Biosafety Level 3 (BSL-3) laboratory at its Frederick, Maryland facility to advance the program.

Tonix Pharmaceuticals (NASDAQTNXP) has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid analgesic developed for the treatment of fibromyalgia. The application is supported by data from two Phase 3 clinical trials, both of which showed significant reductions in fibromyalgia pain. TNX-102 SL, which was granted Fast Track designation in 2024, is designed for bedtime use and targets non-restorative sleep, a key characteristic of fibromyalgia. If approved, TNX-102 SL would be the first drug in a new class of treatments for this chronic pain condition.

Tonix Pharmaceuticals (NASDAQTNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, is collaborating with X-Chem Inc., a leader in small molecule drug discovery. According to the announcement, the two companies are collaborating on an artificial intelligence (“AI”) and machine learning (“ML”) project designed to accelerate development of Tonix’s oral broad-spectrum antivirals. Tonix’s TNX-4200 antiviral program targets the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families.

Tonix Pharmaceuticals (NASDAQTNXP) is spotlighted in a recent article discussing the rising urgent demand for safer, nonaddictive pain-management options. According to the article, Tonix is “developing an innovative solution that could reshape chronic pain treatment”; the company’s proprietary solution features TNX-102 SL, a nonopioid investigational drug targeting fibromyalgia. The U.S. Food and Drug Administration (“FDA”) has granted the drug Fast Track designation, reinforcing the “critical need for new treatments in chronic pain management.”

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.