{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-010643","form_type":"8-K","ticker":"SYBX","cik":"0001527599","company_name":"SYNLOGIC, INC.","filed_at":"2023-01-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:45.394070+00:00","generated_at":"2026-06-20T13:07:00.140641+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Synlogic receives FDA Rare Pediatric Disease Designation for SYNB1934 in PKU","bullets":["FDA granted RPDD for SYNB1934, a synthetic biotic candidate for phenylketonuria (PKU).","Company plans to start Synpheny-3 pivotal Phase 3 study for SYNB1934 in H1 2023.","Follows similar RPDD for SYNB1353 for homocystinuria (HCU) received in December 2022.","Designation highlights the urgent need for new PKU treatment options in children."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-010643","json":"https://secwatch.observer/filing/0001193125-23-010643.json","markdown":"https://secwatch.observer/filing/0001193125-23-010643.md","text":"https://secwatch.observer/filing/0001193125-23-010643.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1527599/000119312523010643/0001193125-23-010643-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1527599/000119312523010643/d457598d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T13:07:00.140641+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"}