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Tonix Pharmaceuticals (NASDAQTNXP) has appointed Gary Ainsworth as Vice President, Market Access, as the company prepares for the potential FDA approval of TNX-102 SL, a non-opioid analgesic for fibromyalgia, with a PDUFA decision date set for Aug. 15, 2025. Ainsworth brings extensive experience from roles at Eversana Intouch, Havas Gemini, Baxter International, Roche Laboratories, and Sanofi, where he developed market access strategies and payer-focused resources. His appointment strengthens Tonix’s commercial strategy to support the launch of TNX-102 SL, aimed at addressing the needs of fibromyalgia patients, a condition primarily affecting women.

Tonix Pharmaceuticals (NASDAQTNXP), a biopharmaceutical company focused on marketed products and development candidates, announced its participation in two investor conferences in January 2025. Seth Lederman, M.D., President and CEO, will present and join a panel discussion at the 8th Annual Neuroscience Innovation Forum on Jan. 12 at the Marines Memorial Club in San Francisco. He will also present at the 2025 Biotech Showcase on Jan. 14 at the Hilton San Francisco Union Square. Replays of the presentations will be available on Tonix’s website under the IR Events tab. Interested investors can arrange meetings through the respective conference coordinators.

Tonix Pharmaceuticals (NASDAQTNXP) announced that the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of Aug. 15, 2025, for a decision on TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. This non-opioid analgesic demonstrated significant pain reduction in two Phase 3 trials—RELIEF and RESILIENT—while maintaining favorable tolerability. Previously granted Fast Track designation, TNX-102 SL aims to address the unmet needs of fibromyalgia patients, offering a potential new class of treatment for this chronic condition that affects over 10 million U.S. adults.

Tonix Pharmaceuticals Holding Corp (NASDAQTNXP) shares are trading lower Tuesday after initially jumping after the company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid. Here's what you need to know.

Tonix Pharmaceuticals (NASDAQTNXP) announced that the U.S. FDA has accepted its New Drug Application (“NDA”) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, following its Fast Track designation in July 2024. The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, where TNX-102 SL met its primary endpoint of significantly reducing daily pain compared to placebo. The drug was generally well-tolerated, with the most common adverse event being temporary tongue or mouth numbness. Tonix aims to address the unmet needs of over 10 million U.S. adults with fibromyalgia, as existing treatments have left patients at risk for opioid prescriptions. The company anticipates potential approval in 2025, with commercial preparations underway alongside its current migraine treatments, Zembrace® SymTouch® and Tosymra®.

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

Tonix Pharmaceuticals (NASDAQTNXP) has submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for TNX-102 SL, its non-opioid drug candidate for managing fibromyalgia. With the global fibromyalgia market projected to grow from $2.8 billion in 2024 to $4.13 billion by 2032, the company anticipates the FDA’s decision on NDA acceptance by mid-December 2024. If accepted, the FDA could decide on approval in 2025, positioning TNX-102 SL for market entry as early as next year. Tonix highlighted the unmet need in fibromyalgia treatment, noting that 85% of patients fail first-line therapy, and 79% require multiple therapies.