Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut 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 that its single-dose mpox vaccine candidate TNX-801 aligns with the World Health Organization's (WHO) newly issued preferred target product profile (TPP) for mpox vaccines. The WHO released its TPP criteria at the Mpox Research and Innovation Scientific Conference held August 29-30, 2024. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature.
TNX-801 has shown single dose protection against a lethal challenge of Clade I monkeypox virus in animal studies. It is designed for percutaneous administration using a bifurcated needle and is expected to have stability at ambient temperature, eliminating the need for ultra-cold storage. The vaccine may also be suitable for use in immunocompromised individuals.
Tonix recently announced a collaboration with Bilthoven Biologics to develop GMP manufacturing processes for its mpox vaccine. The WHO's declaration of mpox as a Public Health Emergency of International Concern (PHEIC) underscores the urgent need for new vaccines to control the outbreak.
Tonix Pharmaceuticals (Nasdaq: TNXP) has appointed Thomas Englese as Executive Vice President of Commercial Operations. Englese brings over 20 years of biopharmaceutical industry experience, specializing in commercial operations, sales, and marketing. This appointment comes as Tonix prepares to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia in October 2024.
Englese's expertise includes launching and managing major brands through all stages of commercialization. His previous roles include Chief Commercial Officer at Tris Pharmaceuticals and Aziyo Biologics, and Senior Vice President at Mallinckrodt PLC. Tonix CEO Seth Lederman expressed confidence in Englese's ability to advance the fibromyalgia program and build out the company's commercial capabilities.
Tonix Pharmaceuticals (TNXP) presented data on TNX-801, a potential mpox vaccine, at the University of Alberta. TNX-801, based on synthetic horsepox, demonstrated efficacy in protecting animals from lethal challenge with clade I monkeypox. New data showed improved tolerability in immunocompromised animals and no evidence of spreading to blood or tissues even at high doses. TNX-801 offers advantages over existing vaccines, including single-dose protection, percutaneous administration, and potential for long-lived immunity. The vaccine has been selected by NIH's Project NextGen for clinical testing. Tonix is collaborating with Bilthoven Biologics to develop GMP manufacturing processes for TNX-801. The company also highlighted the potential of TNX-801 as a viral vector platform for other infectious diseases.
Tonix Pharmaceuticals (Nasdaq: TNXP) has launched a national awareness campaign at PAINWeek about the impact of gastroparesis on oral migraine medication absorption. The campaign, titled 'Does Your Migraine Pill Work Every Time?', aims to educate patients and healthcare providers about the benefits of non-oral migraine treatments like nasal sprays and injectables.
Gastroparesis, a condition that slows stomach emptying, can delay or block the absorption of oral medications, leading to inconsistent migraine relief. Non-oral treatments bypass the digestive system, potentially offering faster relief in as little as 10 minutes. Tonix is launching a disease education website, gpmigraine.com, and supporting a webinar on September 19, 2024, to further educate patients about gastroparesis and migraine management options.
Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL for acute stress reaction (ASR) and PTSD prevention at the 2024 Military Health System Research Symposium. An investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce ASR severity and prevent PTSD is expected to begin in Q3 2024. The OASIS trial will enroll about 180 trauma survivors at emergency departments, randomizing them to receive TNX-102 SL or placebo for two weeks after motor vehicle collisions.
TNX-102 SL showed effects on sleep and PTSD symptoms in previous military-related PTSD trials. The company believes early intervention with TNX-102 SL could reduce ASR symptoms and prevent PTSD development. Tonix also presented data on an automated high-throughput assay for screening wound healing therapeutics.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented data on TNX-102 SL, a potential non-opioid analgesic for fibromyalgia, at the 2024 Military Health System Research Symposium. The Phase 3 RESILIENT study showed statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. Post hoc analyses revealed strong correlations between improvements in pain and sleep quality, supporting the concept of targeting sleep to achieve syndromal improvement in fibromyalgia.
TNX-102 SL was well-tolerated with no new safety signals. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with an FDA decision expected in 2025. The company believes TNX-102 SL could be the first new treatment option for fibromyalgia in 15 years.
Tonix Pharmaceuticals (TNXP) and Bilthoven Biologicals (BBio) have announced a collaboration to advance TNX-801, Tonix's mpox vaccine candidate. This partnership comes as the World Health Organization (WHO) declared the spread of mpox in multiple African countries a public health emergency for the second time in two years. TNX-801 is a live replicating, attenuated virus vaccine based on horsepox, currently in preclinical development to prevent mpox and smallpox.
Key points:
- TNX-801 has shown promising results in animal models, protecting non-human primates against lethal Clade 1 monkeypox virus challenge
- The vaccine is designed to be administered as a single dose, potentially improving acceptance and eliminating partial vaccination issues
- BBio, part of the Cyrus Poonawalla Group, will develop manufacturing processes for potential GMP production
- The collaboration aims to address the global need for an affordable, safe, and effective mpox vaccine
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the 2024 Military Health System Research Symposium (MHSRS) with one oral presentation and three poster presentations. The oral presentation will highlight TNX-102 SL's efficacy in treating fibromyalgia, demonstrating significant improvement in nociplastic pain and six key secondary endpoints. Poster presentations will cover:
1. TNX-102 SL's potential for acute stress disorder treatment
2. An automated high-throughput assay for wound healing therapeutics
3. The AURORA Platform Trial Network for testing interventions to reduce acute stress reaction symptoms
Tonix recently secured a $34 million contract from the U.S. Department of Defense to develop TNX-4200, a broad-spectrum antiviral agent. The company is preparing to submit a New Drug Application for TNX-102 SL for fibromyalgia management in the second half of 2024.
Tonix Pharmaceuticals (Nasdaq: TNXP) has initiated a Phase 2 clinical trial for TNX-1300, a potential treatment for acute cocaine intoxication. The study, named CATALYST, is a single-blind, placebo-controlled trial conducted in emergency departments across six U.S. academic medical centers. TNX-1300 is a recombinant enzyme designed to rapidly degrade cocaine in users. The trial will enroll approximately 60 subjects, comparing a 200 mg dose of TNX-1300 to placebo plus standard care.
Key points:
- TNX-1300 has received Breakthrough Therapy designation from the FDA
- The primary endpoint is reduction in systolic blood pressure after 60 minutes
- Topline results are expected in the first half of 2025
- In 2022, over 27,569 U.S. deaths involved cocaine overdose
- Currently, there is no FDA-approved treatment for cocaine intoxication
Tonix Pharmaceuticals (TNXP) reported Q2 2024 financial results and operational highlights. Key points include:
- On track to submit NDA for TNX-102 SL for fibromyalgia in H2 2024
- FDA granted Fast Track designation for TNX-102 SL
- Awarded $34 million DoD contract for broad-spectrum antiviral drug development
- Q2 2024 net product revenue: $2.2 million
- Cash and equivalents: $4.2 million as of June 30, 2024
- Net loss: $78.8 million ($19.28 per share)
The company is advancing its pipeline, including TNX-102 SL for fibromyalgia, TNX-1300 for cocaine intoxication, and TNX-1500 for organ transplant rejection. Tonix is also developing broad-spectrum antivirals and vaccines for mpox and COVID-19.