Tonix Pharmaceuticals TNXP Soars 12.58% on FDA Approval of Fibromyalgia Therapy

On August 18, 2025, Tonix Pharmaceuticals Holding Corp. (TNXP) experienced a significant surge in its pre-market trading, with shares rising by 12.58%.

This surge can be attributed to the recent FDA approval of Tonix's Tonmya, a groundbreaking therapy for fibromyalgia. Tonmya is the first new treatment for this condition in over 15 years, marking a significant milestone for patients suffering from chronic pain. The approval was based on two pivotal Phase 3 studies that demonstrated Tonmya's efficacy in reducing fibromyalgia pain compared to placebo.

Despite the positive news, Tonix's second-quarter earnings report for 2025 missed market expectations, which could temper investor enthusiasm. Additionally, Noble Financial has downgraded its Q3 2025 earnings estimate for Tonix, projecting a larger loss per share. This pessimistic outlook may influence investor sentiment in the coming months.

Looking ahead, Tonix is scheduled to release its next earnings report on November 9, 2025. The company will also host a webcast and conference call on August 18, 2025, to discuss the approval of Tonmya and its implications for the company's future. Investors will be closely watching these developments to gauge the potential impact on Tonix's stock performance.