TNXP News & Events

Tonix Pharmaceuticals announced that the first participant has been dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead using capsaicin as well as electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers.

Reports Q4 revenue $534M vs. $2.6M last year. Believes that cash resources at December 31, 2025, will meet planned operating and capital expenditure requirements into Q1 2027. "2025 was transformational for Tonix as we achieved FDA approval and began the U.S. commercial launch of TONMYA, our first fully in-house developed product and the first new medicine approved for fibromyalgia in more than 15 years," said CEO Seth Lederman. "...We also meaningfully advanced our robust clinical pipeline in 2025. Tonix in-licensed TNX-4800, a long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, for which there are no FDA-approved vaccines or prophylactics...we plan to discuss Phase 2/3 development with the FDA this year. An additional highlight includes FDA clearance of the Investigational New Drug application for HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL in major depressive disorder, which is expected to initiate enrollment in mid-2026. Looking ahead, our priorities are clear. We are driven to continue our momentum in 2026 as we focus on the successful commercialization of TONMYA, pipeline progress, and sustainable long-term value for patients and shareholders."

Tonix Pharmaceuticals announced two oral presentations on Tonmya, which was investigated as TNX-102 SL at the 8th International Congress on Controversies in Fibromyalgia held on March 9-10, 2026, in Krakow, Poland. Oral Presentation One: "Cyclobenzaprine HCl Sublingual Tablets Provide Rapid Pain Relief in Adults with Fibromyalgia." Tonmya was generally well tolerated, with 6.1% of participants discontinuing due to adverse events versus 3.5% with placebo. The most common treatment-emergent adverse events were oral cavity reactions, including oral hypoesthesia and abnormal product taste, which were typically mild, transient, and self-limited. Oral Presentation Two: "Cyclobenzaprine HCl Sublingual Tablets for the Treatment of Fibromyalgia: Number Needed to Treat and Number Needed to Harm." The LHH was 3.7, indicating that Tonmya provides a nearly four-fold greater likelihood of clinical benefit than adverse event-related discontinuation. The pooled safety data were consistent with the known profile of Tonmya, with no new or unexpected safety signals. The most common treatment-emergent adverse events were oral cavity reactions that were typically mild, transient, and self-limited.

Tonix Pharmaceuticals announced the publication of a paper in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology. Tonmya was investigated as TNX-102 SL and approved by the FDA on August 15, 2025, for the treatment of fibromyalgia in adults. The publication reports findings from two Phase 1 single-dose, open-label studies conducted in healthy adult volunteers. In Study 1, three sublingual formulations of cyclobenzaprine HCl 2.8 mg, each containing a different basifying agent, were compared with oral immediate-release cyclobenzaprine HCl 5 mg under fasting conditions. All sublingual formulations showed rapid absorption and increased relative bioavailability compared with oral IR cyclobenzaprine HCl. The potassium phosphate dibasic formulation demonstrated the most favorable pharmacokinetic profile, with a 154% relative bioavailability compared to oral IR, an absorption lag of approximately three minutes versus approximately 37 minutes for oral IR, and a 783% higher dose-normalized AUC during the first hour post-dose. Based on these results, the potassium phosphate dibasic formulation was selected for further clinical development. In Study 2, TNX-102 SL 2.8 mg and 5.6 mg were evaluated in a crossover design under fasting and fed conditions. The formulation exhibited dose proportionality between the two dose levels, and pharmacokinetic parameters were not affected by a high-calorie, high-fat meal, confirming the absence of a food effect. This study also provided a full clinical characterization of the active metabolite norcyclobenzaprine, demonstrating an elimination half-life of approximately 60 hours. Reduced exposure to norcyclobenzaprine following sublingual administration, as compared with oral delivery, is believed to contribute to the improved durability of efficacy and favorable tolerability profile observed with TONMYA in Phase 3 fibromyalgia studies.Across both studies, single-dose sublingual cyclobenzaprine HCl was generally well tolerated. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events were oral hypoesthesia and abnormal taste. No serious adverse events were reported, and no clinically meaningful changes were observed in laboratory parameters, vital signs, or electrocardiogram findings.