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NEW YORK - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a $282 million market cap biotech company whose stock has surged nearly 39% over the past six months, announced Wednesday that full results from its confirmatory Phase 3 RESILIENT trial for TNX-102 SL have been published in the peer-reviewed journal Pain Medicine, showing statistically significant improvement in reducing fibromyalgia pain compared to placebo.
The trial, which enrolled 457 adults with fibromyalgia across 33 U.S. sites, demonstrated that TNX-102 SL (cyclobenzaprine HCl sublingual tablets) produced a mean reduction of 1.8 points on the daily pain numeric rating scale compared to a 1.2-point reduction for placebo.
The study also showed statistically significant improvements across all six prespecified key secondary endpoints, including Patient Global Impression of Change, Fibromyalgia Impact Questionnaire domains, and sleep disturbance and fatigue measurements.
These results confirm findings from the previously published RELIEF Phase 3 trial, which also demonstrated statistically significant reduction in fibromyalgia pain. Based on these two studies, Tonix submitted a New Drug Application with an FDA target decision date of August 15, 2025. InvestingPro analysis shows analysts maintain a Strong Buy consensus on TNXP, with 8 additional ProTips available to subscribers covering the company’s financial health and market performance.
If approved, TNX-102 SL would be the first new drug for treating fibromyalgia in more than 15 years, according to the company’s press release statement.
The most common side effects reported were oral tingling/numbness and bitter or noticeable aftertaste, which were typically mild and transient. No drug-related serious adverse events or deaths were reported during the trial.
Fibromyalgia is a chronic pain disorder affecting an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. The condition is characterized by chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness.
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride designed for rapid absorption while bypassing first-pass hepatic metabolism.
In other recent news, Tonix Pharmaceuticals Holding Corp. announced promising results from its experimental mpox vaccine candidate, TNX-801, which demonstrated protection against monkeypox in preclinical animal studies. Additionally, Tonix revealed positive data for its cancer treatment candidate, mTNX-1700, which showed increased survival rates in animal models when combined with an anti-PD1 antibody. In financial developments, Tonix plans to raise up to $225 million through two separate common stock offerings, as disclosed in a recent regulatory filing. The company has entered agreements with A.G.P./Alliance Global Partners and Lincoln Park Capital Fund to facilitate these offerings. Furthermore, Tonix has initiated a Phase 2 clinical trial for TNX-102 SL, aimed at treating acute stress reactions, with support from the University of North Carolina and a grant from the U.S. Department of Defense. At its recent annual shareholder meeting, Tonix’s board of directors was re-elected, and several key proposals were approved, including a potential reverse stock split and amendments to stock incentive plans. These developments highlight Tonix’s ongoing efforts in advancing its pharmaceutical pipeline and financial strategy.
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