Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (NASDAQ: TNXP) is advancing development of TNX-801, a single-dose live attenuated virus vaccine candidate for mpox and smallpox. This comes as the WHO declares the mpox outbreak in Africa a global health emergency. Key points:

1. TNX-801 demonstrated efficacy in protecting animals from lethal challenge with monkeypox virus.
2. The vaccine is designed to provide long-term protection with one dose.
3. Clade II mpox is now endemic in the U.S. with >30,000 cases since May 2022.
4. Tonix's vaccine platform has been selected by NIH's Project NextGen for clinical testing.
5. TNX-801 showed potential to prevent clinical disease, lesions, and decrease viral shedding in non-human primates.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Summer 2024 Virtual Investor Summit on August 20, 2024, at 11:00 a.m. ET. The presentation will be available via webcast on the company's website. Tonix is a fully-integrated biopharmaceutical company with marketed products and a development pipeline focused on central nervous system (CNS) disorders.

Key highlights include:

• Plans to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia management in the second half of 2024
• FDA Fast Track designation for TNX-102 SL
• Development of TNX-1300 for cocaine intoxication with Breakthrough Therapy designation
• Immunology portfolio including TNX-1500 for organ transplant rejection and autoimmune diseases
• Commercial products: Zembrace SymTouch and Tosymra for acute migraine treatment

Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL, a sublingual cyclobenzaprine HCl treatment for fibromyalgia, at the IASP 2024 World Congress on Pain. The Phase 3 RESILIENT study showed statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and all six key secondary endpoints, including sleep quality. Post hoc analyses revealed strong correlations between improvements in pain and sleep quality.

TNX-102 SL, designed as a bedtime treatment to target non-restorative sleep, has received Fast Track designation from the FDA for fibromyalgia management. Tonix plans to submit an NDA in the second half of 2024. The treatment was well-tolerated with no new safety signals observed, potentially becoming the first new fibromyalgia treatment option in 15 years.

Tonix Pharmaceuticals (TNXP) has published a research paper in Microorganisms highlighting their proprietary high-throughput, high-content imaging technology for screening convalescent sera. This technology can be used to generate neutralizing, fully-human monoclonal antibodies against SARS-CoV-2 variants and potentially other pathogens.

The company's CEO, Seth Lederman, emphasized Tonix's capabilities in developing antibodies to counter COVID-19 and its variants. Tonix is also developing TNX-801, a live-virus vaccine for mpox and smallpox, and TNX-1800, a potential COVID-19 vaccine selected for NIH's Project NextGen. Additionally, Tonix is working on TNX-4200, an oral CD45 antagonist with broad-spectrum antiviral efficacy, supported by a $34 million DoD/DTRA contract.

The FDA has granted Fast Track designation to Tonix Pharmaceuticals (NASDAQ:TNXP) for TNX-102 SL, a drug candidate for managing fibromyalgia. This recognition underscores fibromyalgia as a serious condition affecting over 10 million Americans. The global fibromyalgia treatment market is projected to reach $3.86 billion by 2031, growing at a 3.3% CAGR. TNX-102 SL, a non-addictive sublingual formulation of cyclobenzaprine hydrochloride, showed significant improvement in fibromyalgia pain in Phase 3 trials. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, potentially becoming the first new fibromyalgia pharmacotherapy in over 15 years.

Tonix Pharmaceuticals (TNXP) reports potential positive impact on the fibromyalgia market for Tonmya™ due to the new definition of Long COVID by the U.S. National Academies (NASEM). Key points:

1. Fibromyalgia is now recognized as a 'diagnosable condition' in Long COVID patients.
2. This may expand the addressable market for Tonmya beyond pre-pandemic estimates.
3. Tonmya, a non-opioid analgesic for fibromyalgia, has Fast Track designation.
4. NDA submission target: second half of 2024, potential FDA approval in 2025.
5. Estimated 14 million U.S. adults suffer from Long COVID, with over 40% potentially presenting fibromyalgia-like symptoms.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced a poster presentation at the IASP 2024 World Congress on Pain, highlighting statistically significant Phase 3 results of Tonmya™ for fibromyalgia management. The presentation, scheduled for August 7, 2024, will focus on targeting non-restorative sleep with TNX-102 SL, showing consistent syndromic improvement. Tonmya has received FDA Fast Track Designation, and Tonix plans to submit a New Drug Application (NDA) in the second half of 2024.

Tonix is developing a portfolio of central nervous system (CNS) disorders treatments, including TNX-1300 for cocaine intoxication with Breakthrough Therapy designation. The company also has immunology and rare disease candidates in development. Tonix Medicines, their commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.

Tonix Pharmaceuticals (Nasdaq: TNXP) has received Fast Track designation from the FDA for Tonmya™, its non-opioid analgesic drug for fibromyalgia. This designation recognizes fibromyalgia as a serious condition affecting over 10 million U.S. adults and aims to expedite FDA review. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with potential market entry in 2025. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years. The company is positioning Tonmya as a first-line, long-term daily treatment option. Fast Track status allows for more frequent FDA interactions and the possibility of Priority Review, potentially accelerating the approval process.

Tonix Pharmaceuticals (NASDAQ:TNXP) has secured up to $34 million in funding from the U.S. Department of Defense to develop broad-spectrum antiviral agents. The five-year deal with the Defense Threat Reduction Agency (DTRA) aims to improve the medical readiness of military personnel in biological threat environments. Tonix's program will focus on optimizing TNX-4200, an oral CD45 antagonist designed for broad-spectrum efficacy against various viral pathogens.

The company plans to leverage its research facilities, including a BSL-3 lab and ABSL-3 facility in Maryland, to accelerate development. This funding validates Tonix's ongoing research and in-house capabilities, supporting the advancement of its antiviral discovery program beyond the traditional 'one bug, one drug' approach.