- Tonix Pharmaceuticals presented **positive preclinical data** for its **TNX-801 mpox and smallpox vaccine candidate** at the World Vaccine Congress–Europe 2025, held from October 14–16, 2025.  **[1430306_df9a7f4b31c04befabaca507f0b415a0_0]** 
- The data demonstrated **favorable safety, immunogenicity, and durable protection** for at least **14 months** post-vaccination across multiple preclinical models.  **[1430306_df9a7f4b31c04befabaca507f0b415a0_0]** 
- These results support the **advancement of TNX-801 toward clinical development**, with Tonix planning a **Phase I clinical study** in Kenya through a collaboration with the Kenya Medical Research Institute (KEMRI).  **[1430306_df9a7f4b31c04befabaca507f0b415a0_0]** **[1430306_df9a7f4b31c04befabaca507f0b415a0_1]**

Tonix Pharmaceuticals Presents Positive Preclinical Data for TNX-801 Mpox Vaccine

- Tonix Pharmaceuticals' CEO presented **favorable safety and biomarker data** from the completed Phase 1 study of **TNX-1500**, an anti-CD40L monoclonal antibody for transplantation and autoimmune diseases, at the 61st Annual Congress of the Japan Society for Transplantation, held **October 9–11, 2025**.  **[1430306_3c3fdeadc3a841cfa502fb28107d3ea2_0]** 
- The company plans to advance **TNX-1500** into **Phase 2 development** for the prevention of kidney transplant rejection and the treatment of autoimmune indications.  **[1430306_3c3fdeadc3a841cfa502fb28107d3ea2_0]** 
- Tonix Pharmaceuticals is a fully integrated biotechnology company with **marketed products**, including the recently FDA-approved **Tonmya** for fibromyalgia, and two treatments for acute migraine in adults.  **[1430306_3c3fdeadc3a841cfa502fb28107d3ea2_2]**

Tonix Pharmaceuticals Presents Positive Phase 1 Data for TNX-1500 and Highlights Marketed Products

- **Tonix Pharmaceuticals Holding Corp. received FDA approval for TONMYA™** (cyclobenzaprine HCl sublingual tablets) on **August 15, 2025**, for the treatment of fibromyalgia in adults.  **[1430306_0001999371-25-014776_ex99-01.htm:1]** **[1430306_0001999371-25-014776_ex99-01.htm:9]** **[1430306_0001999371-25-014776_ex99-01.htm:15]** 
- The company plans a **US launch for TONMYA™ in Q4 2025**, positioning it as the **first FDA-approved medicine for fibromyalgia in over 15 years**.  **[1430306_0001999371-25-014776_ex99-01.htm:1]** 
- TONMYA™ addresses a substantial market, with **over 10 million U.S. adults affected by fibromyalgia** and **2.7 million patients diagnosed and treated annually**.  **[1430306_0001999371-25-014776_ex99-01.htm:2]** 
- In its pipeline, Tonix Pharmaceuticals is **planning to submit an IND for TNX-102 SL for Major Depressive Disorder (MDD) in Q4 2025**, with a Phase 2 trial planned for 2026.  **[1430306_0001999371-25-014776_ex99-01.htm:1]** **[1430306_0001999371-25-014776_ex99-01.htm:9]**

Tonix Pharmaceuticals Receives FDA Approval for TONMYA™ and Plans Q4 2025 Launch

- Tonix Pharmaceuticals appointed **Ganesh Kamath** as **Head of Market Access**, effective **September 29, 2025**.  **[1430306_6d5700b42dd4455db9c51a3ecf231c48_0]** 
- Mr. Kamath brings **over 25 years of market access, pricing, and commercial operations experience** to the company.  **[1430306_6d5700b42dd4455db9c51a3ecf231c48_0]** 
- This appointment strengthens the commercial leadership team in preparation for the **US launch of Tonmya™**, which is **expected in the fourth quarter of 2025**.  **[1430306_6d5700b42dd4455db9c51a3ecf231c48_0]** 
- **Tonmya™** received **FDA approval on August 15, 2025**, for **fibromyalgia in adults**, marking the **first new therapy for the condition in over 15 years**.  **[1430306_6d5700b42dd4455db9c51a3ecf231c48_0]** **[1430306_6d5700b42dd4455db9c51a3ecf231c48_1]**

Tonix Pharmaceuticals Appoints Ganesh Kamath as Head of Market Access

- Tonix Pharmaceuticals Holding Corp. (TNXP) announced the **successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the FDA** for **TNX-102 SL** for the treatment of **major depressive disorder (MDD)** on **September 18, 2025**.  **[1430306_0001999371-25-013498_tnxp_8k-091825.htm:1]** **[1430306_0001999371-25-013498_ex99-01.htm:1]** **[1430306_0001999371-25-013498_tnxp_8k-091825.htm:2]** 
- The company received **positive feedback from the FDA** and plans to pursue a **supplemental new drug application (sNDA)** to expand the therapeutic indication of TNX-102 SL to include MDD.  **[1430306_0001999371-25-013498_ex99-01.htm:1]** **[1430306_0001999371-25-013498_tnxp_8k-091825.htm:2]** 
- An **Investigational New Drug (IND) filing** for TNX-102 SL for MDD is anticipated in the **fourth quarter of 2025**, with **Phase 2 clinical trials** expected to commence shortly thereafter.  **[1430306_0001999371-25-013498_ex99-01.htm:1]** **[1430306_0001999371-25-013498_tnxp_8k-091825.htm:2]** 
- TNX-102 SL is currently **FDA-approved for the treatment of fibromyalgia** under the brand name Tonmya™.  **[1430306_0001999371-25-013498_ex99-01.htm:1]** **[1430306_0001999371-25-013498_ex99-01.htm:2]**

Tonix Pharmaceuticals Holding (TNXP)