Tonix Pharmaceuticals Presents Tonmya Study Results at International Congress
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.
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- Clinical Trial Results: At the 2026 American Academy of Pain Medicine Annual Meeting, Tonix Pharmaceuticals presented data from the Phase 3 RESILIENT trial involving 457 fibromyalgia patients, demonstrating statistically significant pain reduction over 14 weeks, with 30% of patients achieving clinically meaningful pain relief, underscoring the drug's efficacy and safety.
- Market Launch: TONMYA received FDA approval in August 2025 and was commercially launched in the U.S. in November 2025, marking it as the first new treatment for fibromyalgia in over 15 years, addressing the market's need for effective non-opioid analgesics and expected to enhance patient quality of life.
- Unique Drug Mechanism: TONMYA's sublingual formulation allows it to bypass first-pass hepatic metabolism, reducing the formation of the active metabolite norcyclobenzaprine, thereby enhancing the durability of treatment effects compared to traditional oral medications, making it suitable for long-term use.
- Impact on Patient Population: Fibromyalgia affects approximately 6 to 12 million adults in the U.S., with 90% being women; the introduction of TONMYA not only provides a new treatment option for patients but may also reduce reliance on existing medications, improving overall health outcomes and quality of life for those affected.
- Agenda Announcement: Virtual Investor Conferences has announced the Life Sciences Virtual Investor Forum scheduled for March 11-12, 2026, inviting individual and institutional investors to participate for free, aiming to broaden the investor base and enhance company-investor interactions.
- Company Presentation Schedule: The forum will feature presentations from several life sciences companies, including SeaStar Medical Holding Corporation and Nasus Pharma Ltd., with one-on-one management meetings arranged to facilitate direct communication of strategies to investors.
- Platform Advantages: The Virtual Investor Conferences provide a real-time investor engagement solution that replicates the components of an on-site investor conference, enabling companies to access investors more efficiently and enhance presentation effectiveness, thereby increasing investor participation.
- Focus on Industry Innovation: The forum highlights innovators in the life sciences sector, with the EVP of OTC Markets Group stating that the conference offers a unique opportunity for companies to engage with a broader investor audience, fostering strategic communication within the industry.
- FDA Approval Milestone: TONMYA (cyclobenzaprine HCl sublingual tablets) received FDA approval on August 15, 2025, marking the first new treatment for fibromyalgia in adults in over 15 years, which is expected to significantly enhance patient quality of life and treatment options.
- Rapid Absorption Characteristics: The sublingual formulation of TONMYA utilizes a proprietary basifying agent to achieve rapid transmucosal absorption, resulting in a 154% increase in bioavailability compared to oral formulations, which will help patients achieve more durable analgesic effects during sleep while minimizing side effects.
- Clinical Trial Findings: In two Phase 1 clinical trials, TONMYA demonstrated good tolerability with all adverse events being mild or moderate, and no serious adverse events reported, establishing a solid foundation for its market introduction and acceptance.
- Significant Market Potential: Fibromyalgia affects approximately 6 to 12 million adults in the U.S., and the launch of TONMYA not only fills a critical gap in treatment options but also addresses the urgent need for long-term effective therapies, which is expected to drive revenue growth for the company.
- 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.







