Tonix Pharmaceut Stock Price, News & Analysis

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 (NASDAQ: TNXP) is developing TNX-102 SL, a potential non-opioid treatment for fibromyalgia, the prototype of nociplastic pain. Nociplastic pain, recently recognized as the third type of pain alongside nociceptive and neuropathic, results from dysfunctional sensory processing by the nervous system. TNX-102 SL, designed to improve sleep quality in fibromyalgia patients, has shown statistically significant improvement in pain reduction in Phase 3 trials. The FDA has granted Fast Track designation for TNX-102 SL, highlighting the urgent need for new fibromyalgia treatments. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024 and may request Priority Review. If approved, TNX-102 SL could become the first new fibromyalgia treatment in over 15 years, offering hope to millions of sufferers.

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) is developing TNX-801, a vaccine candidate to combat the escalating mpox global health crisis. The vaccine is based on Edward Jenner's smallpox vaccine technology from the 1700s, which successfully eradicated smallpox. TNX-801 has shown promise in non-human primate studies, protecting against lethal doses of the Clade 1 monkeypox virus.

Key features of TNX-801 include:

• Single-dose administration
• Potential for long-term immunity
• Ability to prevent forward transmission
• No need for complex cold-chain storage

The vaccine platform has also been selected for the NIH's NextGen program for COVID-19 vaccine development. Tonix's technology recently received a $34 million contract from the U.S. Department of Defense for developing a broad-spectrum antiviral against potential biowarfare agents.