FAQ on Tonix Pharmaceuticals' NDA Submission for Fibromyalgia Treatment and Mpox Vaccine Development

What is TNX-102 SL and for what condition is it being developed?

TNX-102 SL is a non-opioid analgesic being developed by Tonix Pharmaceuticals for the management of fibromyalgia, with the FDA granting it Fast Track designation to expedite its review process.

What is the significance of the FDA’s Fast Track designation for TNX-102 SL?

The Fast Track designation by the FDA aims to expedite the review process of TNX-102 SL, potentially bringing this fibromyalgia treatment to patients more quickly.

How is Tonix Pharmaceuticals advancing in the development of a mpox vaccine?

Tonix is progressing with TNX-801, a potential mpox vaccine, aligning with the World Health Organization’s target product profile for mpox vaccines, as part of its efforts to modernize solutions for public health challenges.

What other treatments is Tonix Pharmaceuticals developing?

Tonix is also developing TNX-1300 for cocaine intoxication treatment, TNX-1500 for organ transplant rejection and autoimmune diseases, and has a portfolio focused on CNS disorders and infectious diseases.

Where can I find more information about Tonix Pharmaceuticals’ developments?

More information about Tonix Pharmaceuticals and its developments can be found on their website at www.TonixPharma.com or in their newsroom at https://ibn.fm/TNXP.

What is the Phase 2 CATALYST study about?

The Phase 2 CATALYST study involves TNX-1300, a biologic designed to treat cocaine intoxication, which has Breakthrough Therapy designation, marking a significant step in addressing substance abuse disorders.

How does Tonix Pharmaceuticals contribute to military medical readiness?

Tonix was awarded a contract by the U.S. Department of Defense for up to $34 million to develop TNX-4200, small molecule broad-spectrum antiviral agents, aimed at improving the medical readiness of military personnel in biological threat environments.