{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-039410","form_type":"8-K","ticker":"PTIX","cik":"0001022899","company_name":"Protagenic Therapeutics, Inc.new","filed_at":"2026-08-20T15:26:06+00:00","discovered_at":"2026-08-20T15:27:00.455792+00:00","generated_at":"2026-08-20T15:27:06.790969+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Protagenic Therapeutics gets FDA pre-IND feedback with no objections for PT00114 GAD Phase 1 plan","bullets":["FDA identified no clinical hold issues and raised no objection to the three-part Phase 1 design, dose-escalation, and safety review governance.","FDA deemed the potency/comparability strategy, CMC, and nonclinical packages reasonable to support an IND submission.","Company plans to submit the IND before end of 2026 (Q4 2026); targets first patient dosing in first half of 2027.","PT00114 completed ex-US Phase 1 single- and multiple-ascending-dose studies, well tolerated with no serious adverse events.","GAD affects ~6.8M U.S. adults; no new medicine approved specifically for GAD in nearly two decades."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-039410","json":"https://secwatch.observer/filing/0001493152-26-039410.json","markdown":"https://secwatch.observer/filing/0001493152-26-039410.md","text":"https://secwatch.observer/filing/0001493152-26-039410.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/0001493152-26-039410-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-20T15:27:06.790969+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"}