{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-157913","form_type":"8-K","ticker":"PROK","cik":"0001850270","company_name":"PROKIDNEY CORP.","filed_at":"2024-06-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:20.819980+00:00","generated_at":"2026-06-01T05:23:06.395469+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ProKidney reports REGEN-007 Phase 2 interim: eGFR stable over 18 months; manufacturing resumed","bullets":["In Group 1 (n=13), average eGFR change from baseline was -1.3 ml/min/1.73m² at 18 months; subset meeting Phase 3 criteria (n=10) showed -0.6.","No rilparencel-related serious adverse events in any of the 49 patients who received at least one injection.","Manufacturing resumed effective June 1, 2024 for U.S. and non-European clinical sites.","Anticipates QP Declaration of Equivalence to EU GMPs by end of June 2024 to enable European shipments.","PROACT 1 screening resumed under amended protocol enriched for higher risk patients; PROACT 2 activated sites in Spain."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-157913","json":"https://secwatch.observer/filing/0001193125-24-157913.json","markdown":"https://secwatch.observer/filing/0001193125-24-157913.md","text":"https://secwatch.observer/filing/0001193125-24-157913.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850270/000119312524157913/0001193125-24-157913-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850270/000119312524157913/d827829d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T05:23:06.395469+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"}