Fibromyalgia Breakthrough? Tonix Pharma's TNX-102 SL Faces FDA Decision!
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) recently announced its second-quarter 2025 financial results and highlighted key operational achievements. A major focus is the upcoming FDA decision on TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, with a PDUFA goal date of August 15, 2025.
Potential Game-Changer for Fibromyalgia Patients
If approved, TNX-102 SL would represent the first new drug for fibromyalgia in over 16 years. Fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues, affects millions. The FDA has granted TNX-102 SL Fast Track designation, recognizing the seriousness of the condition and the potential benefit of this new therapy.
Positive Phase 3 Results
The Phase 3 RESILIENT study results, published in the peer-reviewed journal Pain Medicine, demonstrated a statistically significant reduction in fibromyalgia pain with once-nightly TNX-102 SL. The treatment was also generally well-tolerated by patients. This data provides strong support for the potential approval of TNX-102 SL.
Financial Stability and Future Outlook
Tonix Pharmaceuticals reported cash and cash equivalents of $125.3 million as of June 30, 2025. The company anticipates that its current cash runway will fund operations into the third quarter of 2026, allowing them to continue advancing their pipeline of development candidates.
In June 2025, Tonix was added to the Russell 3000® and Russell 2000® Indexes, further validating the company's growth and potential.
According to Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, the company is "excited about the potential to make this important new therapy available to patients in the fourth quarter of this year" pending FDA approval.