Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia. The NDA is based on two successful Phase 3 studies showing statistically significant pain reduction. TNX-102 SL has been granted Fast Track designation by the FDA, potentially expediting the review process.

Key points:

• TNX-102 SL could be the first new drug for fibromyalgia in over 15 years
• It targets non-restorative sleep characteristic of fibromyalgia
• The drug was generally well-tolerated in clinical trials
• Fibromyalgia affects more than 10 million adults in the U.S., mostly women
• If approved, TNX-102 SL would be the first in a new class of analgesic drugs for fibromyalgia

The company expects an FDA decision on approval in 2025, pending acceptance of the NDA for review.

Tonix Pharmaceuticals (Nasdaq: TNXP) has announced an AI and ML research collaboration with X-Chem to accelerate the development of oral broad-spectrum antivirals. The collaboration focuses on Tonix's TNX-4200 antiviral program, which aims to develop oral CD45 phosphatase inhibitors with broad-spectrum activity against various viral families.

Tonix has been awarded a contract with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the TNX-4200 program, including an IND submission and a Phase 1 clinical study. The collaboration with X-Chem is expected to optimize the physicochemical properties, pharmacokinetics, and safety attributes of Tonix's drug candidates.

Tonix plans to leverage its research facilities, including a BSL-3 lab and an ABSL-3 facility at its research and development center in Frederick, Md., to support the development of these host-directed broad-spectrum antiviral programs.

Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-102 SL, a non-opioid drug for fibromyalgia, addressing the urgent need for safer pain management options amid the opioid crisis. The company plans to submit a New Drug Application (NDA) in October 2024, with potential for Priority Review. TNX-102 SL targets disturbed sleep in fibromyalgia patients, offering a novel approach to pain management without addiction risks.

Simultaneously, Vertex Pharmaceuticals has filed an NDA for VX-458, a non-opioid acute pain treatment granted Priority Review by the FDA. These developments reflect a broader industry shift towards non-addictive painkillers, supported by government initiatives like the HEAL Initiative. With an estimated 100 million Americans affected by chronic pain, including 10 million with fibromyalgia, these new treatments could significantly impact pain management practices and help combat the opioid epidemic.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the 'Endpoints' panel at the RECOVER Treating Long COVID (TLC) workshop hosted by the Foundation for the National Institutes of Health (FNIH) and National Institute of Allergy and Infectious Diseases (NIAID). CEO Dr. Seth Lederman shared insights from developing TNX-102 SL for fibromyalgia and Long COVID.

Dr. Lederman recommended validating Patient Global Impression of Change (PGIC) as a primary endpoint for Long COVID therapeutic trials, drawing parallels to the successful use of Progression-Free Survival in cancer drug development. Tonix expects to submit a New Drug Application (NDA) for TNX-102 SL in fibromyalgia to the FDA in October.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the issuance of U.S. Patent No. 12,097,183, covering the subcutaneous delivery of Zembrace® SymTouch® (sumatriptan succinate injection) for migraine treatment. The patent, expected to provide market exclusivity until 2036, claims the use of a pre-filled autoinjector for treating migraines via subcutaneous administration.

Tonix recently launched an educational campaign, "Does Your Migraine Pill Work Every Time?" to promote non-oral migraine medications. The company is also launching a new website, www.gpmigraine.com, to educate patients about gastroparesis and migraine, emphasizing how non-oral medicines can help manage migraines more effectively.

Tonix Pharmaceuticals presented data on TNX-102 SL for fibromyalgia at the PDDS 2024 conference. The presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, a sublingual cyclobenzaprine HCl tablet. Key points include:

1. Patents based on TNX-102 SL's eutectic composition are expected to provide market exclusivity until at least 2034.

2. FDA New Drug Application (NDA) submission is on track for October 2024, with Fast Track designation granted.

3. The Phase 3 RESILIENT study demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and all six key secondary endpoints.

4. TNX-102 SL's formulation allows for efficient transmucosal absorption and targeting of disturbed sleep.

5. In vitro tests have been developed to support manufacturing processes and product uniformity.

Tonix Pharmaceuticals (Nasdaq: TNXP) has been issued U.S. Patent No. 12,090,139 by the United States Patent and Trademark Office for its Tosymra® (sumatriptan nasal spray) 10mg, indicated for the acute treatment of migraine in adults. The patent, titled 'Formulations Comprising Triptan Compounds', covers the pharmaceutical composition, method of treating migraine via intranasal administration, and intranasal delivery system for Tosymra®. Set to expire in 2030, this patent strengthens Tosymra®'s market position as a differentiated drug with a unique administration method. CEO Seth Lederman emphasized that this new patent enhances Tosymra®'s intellectual property protection and solidifies its market presence.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is developing TNX-801, a promising single-dose mpox vaccine candidate that aligns with the World Health Organization's (WHO) preferred target product profile. TNX-801 shows potential advantages over current FDA-approved vaccines Jynneos and ACAM2000, including better tolerability, single-dose protection, and suitability for immunocompromised individuals. The vaccine has demonstrated efficacy against the new, more lethal Clade I mpox strain in preclinical trials. TNX-801's lyophilized version can be stable at ambient temperatures, making it more accessible in regions with cold-chain infrastructure. Tonix has partnered with Bilthoven Biologics to scale up production, potentially enabling global distribution to address the urgent need for a safer, more effective mpox vaccine.

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.