Tonix Pharmaceuticals Presents Tonmya Study Data in Boston
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.
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- New Drug Presentation: Tonix Pharmaceuticals will showcase its new drug Tonmya™ at the 2026 American Academy of Pain Medicine (AAPM) Annual Meeting, marking the first new treatment for fibromyalgia in over 15 years, which is expected to attract significant industry attention.
- Clinical Outcomes: Research indicates that TNX-102 SL produces clinically meaningful improvements in patient-centered outcomes, further validating its potential in treating fibromyalgia and potentially driving market demand.
- Conference Details: The poster will be presented on March 6, 2026, at 4:55 PM in Salt Lake City, with Dr. Errol Gould, Vice President of Medical Affairs at Tonix, as the presenter, likely drawing interest from numerous professionals.
- Product Line Expansion: Tonix is also conducting clinical trials for other drugs, including those targeting major depressive disorder and acute stress disorder, demonstrating the company's broad positioning in the CNS field and future growth potential.
- Nasdaq Uplisting: Tonix Pharmaceuticals commenced trading on the Nasdaq Global Select Market on March 3, 2026, reflecting compliance with higher financial and corporate governance standards, which may enhance visibility among institutional investors and improve liquidity.
- CEO Statement: CEO Seth Lederman emphasized that this uplisting is a significant milestone, indicating the company's commitment to driving growth and creating shareholder value, suggesting that Tonix has achieved notable financial and operational progress that could lead to increased trading volumes and better access to institutional investors.
- Stock Trend: Currently, Tonix Pharmaceuticals shares are down 2% at $13.70 during premarket trading, and the stock is trading 9.8% below its 20-day simple moving average, indicating a bearish trend in the short term and reflecting ongoing challenges in the stock's performance.
- Technical Indicators: The relative strength index (RSI) is at 44.45, considered neutral, indicating that the stock is neither overbought nor oversold, while the MACD is at 0.15, below its signal line at 0.22, suggesting bearish pressure on the stock, resulting in mixed momentum in performance.
- Successful Uplisting: Tonix Pharmaceuticals has received Nasdaq approval to transfer its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market, with trading expected to commence on March 3, 2026, signifying the company's compliance with higher financial and corporate governance standards.
- Enhanced Market Recognition: This uplisting is anticipated to increase Tonix's visibility among institutional investors, improve liquidity, and broaden market recognition, potentially leading to higher trading volumes and a wider investor base.
- Strategic Milestone: CEO Seth Lederman stated that this uplisting represents an important milestone for Tonix, as the company aims to leverage this enhanced platform to drive growth and create value for shareholders, reflecting its financial and operational growth.
- Product Line Expansion: Tonix focuses on CNS and immunology treatments, with its new drug TONMYA providing the first new therapy for fibromyalgia in over 15 years, showcasing the company's potential in addressing high unmet medical needs.
- Successful Uplisting: Tonix Pharmaceuticals has received Nasdaq approval to transfer its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market, with trading expected to commence on March 3, 2026, reflecting the company's compliance with higher financial and corporate governance standards.
- Enhanced Market Recognition: This uplisting is expected to increase Tonix's visibility among institutional investors, improve liquidity, and broaden market recognition, potentially leading to increased trading volumes and greater value creation for shareholders.
- Strategic Development Milestone: CEO Seth Lederman stated that this uplisting represents an important milestone for the company, as Tonix aims to leverage this enhanced platform to drive growth and create shareholder value, demonstrating confidence in its future prospects.
- Product Line Expansion: Tonix focuses on CNS and immunology treatments, with its new drug TONMYA™ providing the first new therapy for fibromyalgia in over 15 years, further solidifying its market position in the biotechnology sector.
- Successful Phase 3 Trial: Tonix Pharmaceuticals presented positive data for TONMYA at the Non-Opioid Pain Therapeutics Summit in Boston, demonstrating its significant pain reduction capabilities, thereby reinforcing its position as a non-opioid treatment option.
- Patient Recruitment and Study Design: The RESILIENT trial was a 14-week, randomized, double-blind, placebo-controlled study conducted at 34 U.S. sites, enrolling 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia, ensuring the reliability of the results.
- Side Effects and Tolerability: TONMYA was well tolerated, with a discontinuation rate due to adverse events of 6.1% in the treatment group compared to 3.5% in the placebo group, and most adverse events were mild oral reactions, indicating its safety profile.
- Market Outlook and Approval Information: TONMYA received FDA approval in August 2025 and became commercially available in the U.S. in November 2025, marking the first new prescription medicine for fibromyalgia in over 15 years, expected to meet the treatment needs of over 10 million adults in the U.S.
- Clinical Trial Results: At the 2026 Non-Opioid Pain Therapeutics Summit, TONMYA demonstrated a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) compared to placebo in the RESILIENT study, with an effect size of 0.38, indicating its efficacy in treating fibromyalgia.
- Unique Dosing Method: TONMYA's sublingual formulation is designed for nighttime administration, bypassing first-pass metabolism to optimize drug exposure during sleep while limiting daytime exposure to the active metabolite, enhancing the overall treatment experience for patients.
- Good Tolerability: The study showed that TONMYA was well tolerated, with an adverse event-related discontinuation rate of 6.1%, lower than the 3.5% for placebo, and the most common adverse events were mild oral reactions, indicating a favorable safety profile.
- Market Demand Alignment: With over 10 million adults in the U.S. affected by fibromyalgia and existing treatments often limited by tolerability, the introduction of TONMYA provides an effective non-opioid alternative, addressing the urgent market need for new therapies.





