{"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","discovered_at":"2026-05-14T18:03:35.416126+00:00","generated_at":"2026-06-11T23:11:10.587614+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA deems IMC-1 chronic toxicology program adequate; Virios plans Phase 3 start mid-2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-014077","json":"https://secwatch.observer/filing/0001558370-23-014077.json","markdown":"https://secwatch.observer/filing/0001558370-23-014077.md","text":"https://secwatch.observer/filing/0001558370-23-014077.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T23:11:10.587614+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}