Tonix targets August PDUFA date for Fibromyalgia drug candidate, advances mpox vaccine strategy

Tonix Pharmaceuticals Holdings CEO Dr Seth Lederman joined Steve Darling from Proactive to discuss updates on two of the company’s key investigational therapies: TNX-801 and TNX-102 SL. Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Lederman shared recent findings on TNX-801, a recombinant horsepox-derived live-virus vaccine candidate for mpox and smallpox presented at the Vaccine Congress 2025 in Vienna. The latest data demonstrate that TNX-801 delivers durable humoral and cellular immunity from a single dose, while remaining highly attenuated—replicating much times less than licensed vaccinia strains in primary human dermal cells. In interferon receptor knockout mice, it was shown to be up to 100,000-fold less virulent than legacy vaccines. The company announced that subcutaneous (s.c.) administration provides equivalent protection to the traditional percutaneous method. This finding supports a development shift toward the s.c. format, aligning TNX-801 with standard administration routes for most live-virus vaccines. Potential benefits include reduced risk of scarring, bacterial superinfection, and inadvertent transfer of vaccine to other parts of the body—challenges associated with percutaneous delivery. In addition to the vaccine data, Lederman also shared the update that a peer-reviewed manuscript has recently published on-line in the journal Pain Medicine describing the Phase 3 RESILIENT trial of TNX-102 SL, a centrally acting, non-opioid analgesic for fibromyalgia pain. The randomized, double-blind, placebo-controlled Phase 3 study enrolled 457 patients across 33 U.S. sites. Participants received a stepped dose of TNX-102 SL, beginning at 2.8 mg for two weeks and escalating to 5.6 mg for twelve weeks. TNX-102 SL was well tolerated, with the most common side effects being mild and transient oral sensations. No drug-related serious adverse events or deaths were reported. These updates reinforce Tonix’s strategic focus on unmet medical needs across infectious disease and chronic pain indications. TNX-801’s next-gen vaccine and TNX-102 SL’s non-opioid analgesic for fibromyalgia relief position the company as a leader in advancing novel vaccines and therapeutics #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #MPOXVaccine #Smallpox #TNX801 #VaccineDevelopment #ClinicalTrials #PharmaceuticalNews #MedicalResearch #WHO #GlobalHealth #InfectiousDiseases #Biopharma #ProactiveInvestors #tnx-102sl