---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-014108"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-09-29T23:59:59+00:00"
generated_at: "2026-05-17T05:23:29.056915+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Tonix plans Phase 2 trial of TNX-2900 for Prader-Willi syndrome in 2026

## Summary
- TNX-2900 (intranasal magnesium-potentiated oxytocin) to enter Phase 2 in children ages 8-17.5 with PWS, starting 2026.
- FDA cleared IND; Orphan Drug and Rare Pediatric Disease designations; eligible for Priority Review Voucher upon approval.
- Phase 2 trial is randomized, double-blind, placebo-controlled; 12-week treatment; 3 dose arms vs placebo (1:1:1:1).
- Primary endpoint: change from baseline in Hyperphagia Questionnaire (HQ-CT); secondary: behavior, caregiver burden, quality of life.
- PWS affects 1 in 10,000-30,000 births; average life expectancy <30 years due to hyperphagia-driven obesity.

## SEC filing metadata
- accession: 0001999371-25-014108
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-09-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000199937125014108/0001999371-25-014108-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125014108/tnxp-8k_092925.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-014108
- JSON: https://secwatch.observer/filing/0001999371-25-014108.json
- Plain text: https://secwatch.observer/filing/0001999371-25-014108.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.