Tonix launches first approved drug TONMYA, expands pipeline with Lyme prevention asset

Filed March 12, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 18, 2025 · ~1 min read

Key Changes

• high

  TONMYA received FDA approval in August 2025 and launched in November 2025, converting Tonix from development-stage to commercial-stage company with three marketed products and worldwide commercialization rights.

  MD&A: TONMYA FDA approval and launch verify on EDGAR →
• high

  Company raised $217 million via ATM offerings in 2025 (including $104 million from new $400 million facility) to fund TONMYA launch and pipeline expansion, while paying off $11 million term loan in Q1 2025.

  MD&A: 2025 at-the-market offering and capital raised verify on EDGAR →
• high

  FDA cleared IND for TNX-102 SL in major depressive disorder in November 2025 with potentially pivotal Phase 2 study planned for mid-2026, representing significant label-expansion opportunity beyond fibromyalgia.

  MD&A: TNX-102 SL for major depressive disorder verify on EDGAR →