{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-159041","form_type":"8-K","ticker":"PROK","cik":"0001850270","company_name":"PROKIDNEY CORP.","filed_at":"2025-07-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.355217+00:00","generated_at":"2026-05-18T06:31:55.719397+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"ProKidney gains FDA alignment on accelerated approval pathway for rilparencel; topline data Q2 2027","bullets":["FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel in CKD with type 2 diabetes.","Effect size of at least 1.5 mL/min/1.73m2/year required versus sham; nearly half of required patients enrolled.","Phase 3 PROACT 1 can serve as both the accelerated and confirmatory study; confirmatory readout timing in 1H 2026.","Topline data for accelerated approval BLA submission anticipated in Q2 2027.","Rilparencel holds RMAT designation; CEO called it a critical regulatory milestone."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-159041","json":"https://secwatch.observer/filing/0001193125-25-159041.json","markdown":"https://secwatch.observer/filing/0001193125-25-159041.md","text":"https://secwatch.observer/filing/0001193125-25-159041.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850270/000119312525159041/0001193125-25-159041-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850270/000119312525159041/d477465d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T06:31:55.719397+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"}