- 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)