TNXP News & Events

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.

Tonix Pharmaceuticals announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market is expected to commence at the open of market on March 3 under the company's existing ticker symbol "TNXP."

Tonix Pharmaceuticals presented data on Tonmya, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29, 2026, in Boston, Massachusetts. The data presented at the Summit come from RESILIENT, a 14-week randomized, double-blind, placebo-controlled Phase 3 trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Participants received Tonmya or placebo administered sublingually at bedtime. Treatment with Tonmya resulted in a statistically significant reduction in weekly average pain scores at Week 14 versus placebo, with an effect size of 0.38. The study also demonstrated significant improvements in key secondary endpoints, including sleep disturbance, fatigue, and the Symptoms and Function domains of the Fibromyalgia Impact Questionnaire-Revised. Tonmya was well tolerated, with minimal impact on weight and blood pressure, and a rate of adverse event-related discontinuations of 6.1% on Tonmya vs. 3.5% on placebo. The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.