secwatch.observer — SEC 8-K summary
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Issuer:     Tonix Pharmaceuticals Holding Corp. (TNXP)
CIK:        0001430306
Form:       8-K
Filed at:   2026-03-10T23:59:59+00:00
Accession:  0001999371-26-005466
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tonix unveils post hoc data: TONMYA pain relief from Day 2; NNT=7, NNH=26
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- Post hoc analysis of Phase 3 RESILIENT trial (n=457) shows TONMYA pain improvement vs placebo from Day 2, significant through Week 14 (p<0.001).
- Primary endpoint met with LS mean treatment difference of -0.65 in weekly pain score; all key secondary endpoints significant.
- Pooled analysis (n=959) reports NNT for ≥30% pain reduction at Week 14 = 7 (95% CI 5-12); NNH for discontinuation = 26 (95% CI 14-110).
- LHH = 3.7, indicating nearly 4-fold greater likelihood of clinical benefit vs adverse event-related discontinuation.
- TONMYA launched in November 2025 as first fibromyalgia approval in 15 years; mild transient oral hypoesthesia and dysgeusia most common adverse events.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1430306/000199937126005466/0001999371-26-005466-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1430306/000199937126005466/tnxp-8k_031026.htm
  HTML page:      https://secwatch.observer/filing/0001999371-26-005466

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