Tonix Pharmaceuticals (NASDAQ: TNXP) surged nearly 55% after announcing the FDA will not require an Advisory Committee meeting for its lead drug candidate, TNX-102 SL, intended for fibromyalgia treatment. This keeps the company on track for a regulatory decision by August 15, 2025.
If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and introduce a novel, non-opioid option for managing the condition’s chronic pain and sleep-related symptoms. The sublingual formulation of cyclobenzaprine hydrochloride is designed for bedtime use and has previously received Fast Track designation.
Tonix plans to launch the drug in Q4 2025. The company’s broader pipeline includes treatments for CNS disorders, addiction, and infectious diseases, positioning it for a potentially transformative year ahead.
Upon the announcement, Seth Lederman, M.D., President, and Chief Executive Officer of Tonix Pharmaceuticals stated: “We are pleased that FDA will not require an advisory committee meeting as part of the regulatory review process for TNX-102 SL. We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. We believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of 2025 if approved by the FDA.”
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