{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-034422","form_type":"8-K","ticker":"RLAY","cik":"0001812364","company_name":"Relay Therapeutics, Inc.","filed_at":"2026-02-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.268739+00:00","generated_at":"2026-05-16T05:22:53.714668+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Relay's zovegalisib granted FDA Breakthrough Therapy Designation for PIK3CA-mutant breast cancer","bullets":["FDA granted Breakthrough Therapy Designation to zovegalisib + fulvestrant for PIK3CA-mutant HR+/HER2- advanced breast cancer after CDK4/6i.","Supported by ReDiscover trial data: 600mg BID fasted (N=52) and 400mg BID fed (N=57, Phase 3 dose) with comparable exposures.","Phase 3 dose 400mg BID fed data to be presented first at ESMO Targeted Anticancer Congress on March 16, 2026.","BTD aims to accelerate development and review; provides Fast Track features and enhanced FDA guidance."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-034422","json":"https://secwatch.observer/filing/0001193125-26-034422.json","markdown":"https://secwatch.observer/filing/0001193125-26-034422.md","text":"https://secwatch.observer/filing/0001193125-26-034422.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1812364/000119312526034422/0001193125-26-034422-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1812364/000119312526034422/rlay-20260203.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T05:22:53.714668+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"}