secwatch.observer — SEC 8-K summary
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Issuer:     Tonix Pharmaceuticals Holding Corp. (TNXP)
CIK:        0001430306
Form:       8-K
Filed at:   2026-06-29T11:05:56+00:00
Accession:  0001493152-26-030408
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tonix enrolls first patient in Phase 2 MDD study of TNX-102 SL (TONMYA)
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- First patient enrolled in HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL 5.6 mg as first-line monotherapy for major depressive disorder.
- Primary endpoint: change from baseline in MADRS total score at Week 6; about 360 patients at ~30 US sites.
- TNX-102 SL (TONMYA) was FDA approved for fibromyalgia in August 2025; MDD indication is investigational.
- CEO notes TNX-102 SL targets poor sleep quality; prior signals in PTSD and fibromyalgia studies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1430306/000149315226030408/0001493152-26-030408-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1430306/000149315226030408/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-030408

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer