Tonix Pharmaceuticals Secures Approval for Fibromyalgia Treatment, Shares Surge

Tonix Pharmaceuticals' stock is up 18% after securing FDA approval for its fibromyalgia treatment. The company's shares had dropped 15% earlier in the day. The approval marks a significant milestone for Tonix and could potentially boost investor confidence in the company.

Tonix Pharmaceuticals (TNXP) saw its stock price rise by 18% following the U.S. Food and Drug Administration (FDA) approval of Tonmya™, a new treatment for fibromyalgia. The approval marks a significant milestone for the company, which had seen its shares drop by 15% earlier in the day [1].

Tonmya™, a sublingual formulation of cyclobenzaprine HCl, is the first new FDA-approved therapy for fibromyalgia in over 15 years. The approval comes after two pivotal Phase 3 clinical trials involving nearly 1,000 patients demonstrated significant pain reduction compared to placebo over 14 weeks [2].

The medication is designed for once-daily bedtime use, with a sublingual formulation to facilitate rapid absorption into the bloodstream. The FDA approval follows a comprehensive safety evaluation across three Phase 3 trials with over 1,400 patients, showing that Tonmya™ was generally well-tolerated with the most common adverse effects including oral hypoesthesia, oral discomfort, and somnolence [2].

The commercial availability of Tonmya™ is anticipated in the fourth quarter of 2025, targeting a U.S. market of over 10 million adults affected by fibromyalgia. This approval represents a transformative step for Tonix Pharmaceuticals, moving the company from a development-stage entity to a potential revenue-generating commercial enterprise [1].

Tonix Pharmaceuticals will 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 of the call will be available on the Investors section of Tonix's website [2].

References:
[1] https://www.gurufocus.com/news/3065191/tonix-pharmaceuticals-announces-fda-approval-of-tonmyacyclobenzaprine-hcl-sublingual-tablets-for-the-treatment-of-fibromyalgia-tnxp-stock-news
[2] https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of