---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-014077"
form_type: "8-K"
ticker: "DWTX"
cik: "0001818844"
company_name: "Dogwood Therapeutics, Inc."
filed_at: "2023-08-09T23:59:59+00:00"
generated_at: "2026-06-11T23:11:10.587614+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA deems IMC-1 chronic toxicology program adequate; Virios plans Phase 3 start mid-2024

## Summary
- FDA communicated that IMC-1 chronic toxicology studies appear adequate to support safety at proposed dose for chronic use.
- Virios plans to initiate a pharmacokinetic (pK) study this year and resubmit final Phase 3 program outline and protocols to FDA.
- Goal to begin enrollment in first fibromyalgia Phase 3 safety and efficacy study in mid-2024.
- Phase 3 plan includes two adequate and well-controlled studies and a long-term extension trial targeting community-based FM patients.
- Company to use 505(b)(2) regulatory pathway; FORTRESS Phase 2b results informed Phase 3 design.

## SEC filing metadata
- accession: 0001558370-23-014077
- form_type: 8-K
- ticker: DWTX
- cik: 0001818844
- company_name: Dogwood Therapeutics, Inc.
- filed_at: 2023-08-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818844/000155837023014077/0001558370-23-014077-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818844/000155837023014077/tmb-20230809x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-014077
- JSON: https://secwatch.observer/filing/0001558370-23-014077.json
- Plain text: https://secwatch.observer/filing/0001558370-23-014077.txt

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