{"schema_version":"secwatch.filing_event.v1","accession":"0001708599-25-000126","form_type":"8-K","ticker":"SER","cik":"0001708599","company_name":"Serina Therapeutics, Inc.","filed_at":"2025-11-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.225387+00:00","generated_at":"2026-05-17T00:54:34.085481+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Serina Therapeutics announces FDA clinical hold on SER-252 IND for advanced Parkinson's disease","bullets":["FDA placed clinical hold on SER-252 IND, requesting additional info on a commonly used excipient; not related to active drug or mechanism.","Serina expects formal clinical-hold letter within 30 days and will work expeditiously with FDA to address requests.","FDA previously indicated support for SER-252 development under 505(b)(2) NDA pathway; CEO remains confident in program.","SER-252 is Serina's lead program for advanced Parkinson's; Phase 1b trial designed as randomized, double-blind, placebo-controlled."],"urls":{"canonical":"https://secwatch.observer/filing/0001708599-25-000126","json":"https://secwatch.observer/filing/0001708599-25-000126.json","markdown":"https://secwatch.observer/filing/0001708599-25-000126.md","text":"https://secwatch.observer/filing/0001708599-25-000126.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1708599/000170859925000126/0001708599-25-000126-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1708599/000170859925000126/ser-20251103.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:54:34.085481+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"}