{"filing":{"accession_number":"0001493152-26-039410","cik":"0001022899","ticker":"PTIX","company_name":"Protagenic Therapeutics, Inc.\\new","form":"8-K","filing_date":"2026-08-20","report_date":"2026-08-20","primary_document":"form8-k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/form8-k.htm"},"events":[{"id":28779,"run_id":26338,"accession_number":"0001493152-26-039410","anchor_item_number":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Protagenic announced receipt of FDA written responses to its Type B pre-IND meeting request for PT00114, with FDA raising no objections to the planned Phase 1 program design, CMC, and nonclinical packages. The company plans to submit an IND before end of 2026 and target first patient dosing in H1 2027. This is a material regulatory milestone for a clinical-stage biopharmaceutical company advancing its lead product candidate, but does not fit the specific categories of earnings, M\u0026A, impairment, litigation, or other named event types—it is a significant operational/regulatory development in the drug development pathway.","company_name":"Protagenic Therapeutics, Inc.\\new","ticker":"PTIX","filing_date":"2026-08-20","form":"8-K","submitted_at":null,"items":null}],"classifications":[{"id":30824,"accession_number":"0001493152-26-039410","item_number":null,"item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Protagenic announced receipt of FDA written responses to its Type B pre-IND meeting request for PT00114, with FDA raising no objections to the planned Phase 1 program design, CMC, and nonclinical packages. The company plans to submit an IND before end of 2026 and target first patient dosing in H1 2027. This is a material regulatory milestone for a clinical-stage biopharmaceutical company advancing its lead product candidate, but does not fit the specific categories of earnings, M\u0026A, impairment, litigation, or other named event types—it is a significant operational/regulatory development in the drug development pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-20T15:26:40.338463+00:00","company_name":"Protagenic Therapeutics, Inc.\\new","ticker":"PTIX","filing_date":"2026-08-20"}]}