Tonix Pharmaceuticals (NASDAQ: TNXP) 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.
To view the full press release, visit https://ibn.fm/KSgIJ
About Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) this month for TNX-102 SL, a product candidate for which two statistically significant phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the phase 3 program. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced that the U.S. Department of Defense (“DoD”), Defense Threat Reduction Agency (“DTRA”) awarded it a contract for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland. The company’s Good Manufacturing Practice (“GMP”)-capable advanced manufacturing facility in Dartmouth, Maryland, was purpose-built to manufacture TNX-801, and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R)(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP
About InvestorWire
InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.
For more information, please visit https://www.InvestorWire.com
Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer
InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
Editor@InvestorWire.com
InvestorWire is powered by IBN
