{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-094445","form_type":"8-K","ticker":"PROK","cik":"0001850270","company_name":"PROKIDNEY CORP.","filed_at":"2025-07-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.354736+00:00","generated_at":"2026-05-18T09:08:01.422879+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ProKidney reports statistically significant Phase 2 REGEN-007 results for rilparencel; FDA Type B meeting set","bullets":["eGFR slope improved 78% from -5.8 to -1.3 mL/min/1.73m² per year (p<0.001) in Group 1 (n=24).","Group 2 showed 50% improvement but not statistically significant (p=0.085); evidence of dose response.","No rilparencel-related serious adverse events observed; safety consistent with prior studies and kidney biopsy.","FDA Type B meeting set for summer 2025 to confirm eGFR slope as surrogate endpoint for accelerated approval.","Full results submitted to ASN 2025 Kidney Week as late-breaking clinical trial."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-094445","json":"https://secwatch.observer/filing/0000950170-25-094445.json","markdown":"https://secwatch.observer/filing/0000950170-25-094445.md","text":"https://secwatch.observer/filing/0000950170-25-094445.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850270/000095017025094445/0000950170-25-094445-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850270/000095017025094445/prok-20250708.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T09:08:01.422879+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"}