Tonix Pharmaceuticals' Stock Soars 19% on FDA Approval for Fibromyalgia Treatment, Tonmya

Tonix Pharmaceuticals' stock surged 19% after the FDA approved Tonmya, its new fibromyalgia treatment. Analysts predict significant upside potential, with a high price target of $70.00. The FDA approval marks a significant milestone in the pharmaceutical industry and reflects confidence in TNXP's market potential.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) experienced a significant boost in its stock price, surging by 19%, following the U.S. Food and Drug Administration (FDA) approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia [1]. This approval marks a significant milestone in the pharmaceutical industry and underscores the confidence analysts have in Tonix's market potential.

The FDA approval of Tonmya is a landmark event, as it is the first new therapy for fibromyalgia in over 15 years. Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S., predominantly women [1]. Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, demonstrated significant pain reduction compared to placebo in two pivotal Phase 3 clinical trials [1]. The approval incorporates efficacy data from these trials, which enrolled nearly 1,000 patients and showed that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks.

Analysts predict substantial upside potential for Tonix Pharmaceuticals, with a high price target of $70.00. The approval of Tonmya is expected to bring renewed hope to millions of people suffering from fibromyalgia and could significantly improve the lives of patients by addressing the chronic pain and nonrestorative sleep associated with the condition [1].

Tonmya's sublingual formulation allows for rapid absorption into the bloodstream, bypassing first-pass hepatic metabolism and reducing the production of long half-life active metabolites [1]. This formulation is designed to provide quick and durable pain relief with a tolerable safety profile. The most common adverse events were oral hypoesthesia, oral discomfort, and somnolence, all of which were generally well tolerated [1].

Tonix Pharmaceuticals plans to host a webcast and conference call on Monday, August 18, 2025, at 8:30 AM ET, to discuss the approval of Tonmya. The live webcast will be available on the Investors section of Tonix's website [1]. Commercial availability of Tonmya is expected in the fourth quarter of this year.

References:

[1] Tonix Pharmaceuticals Holding Corp. (2025). Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of Fibromyalgia in Adults. Retrieved from https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of