{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-124585","form_type":"8-K","ticker":"PROK","cik":"0001850270","company_name":"PROKIDNEY CORP.","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:10.048516+00:00","generated_at":"2026-05-30T02:14:04.142269+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA confirms PROACT 1 Phase 3 may support full approval; Q3 cash $406.8M","bullets":["FDA Type B meeting confirms PROACT 1 Phase 3 could be sufficient for BLA; accelerated approval pathway available using eGFR slope as surrogate endpoint.","Cash, equivalents and marketable securities $406.8M at Sept 30, 2024, expected to fund operations into 2027.","Q3 2024 net loss before noncontrolling interest $41.1M vs $42.0M in Q3 2023; R&D $31.3M, G&A $17.7M including $5.3M impairment.","Presented five posters at ASN Kidney Week including Phase 2 REGEN-007 late-breaking data.","Shares outstanding: 291,661,950 Class A and B ordinary shares."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-124585","json":"https://secwatch.observer/filing/0000950170-24-124585.json","markdown":"https://secwatch.observer/filing/0000950170-24-124585.md","text":"https://secwatch.observer/filing/0000950170-24-124585.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850270/000095017024124585/0000950170-24-124585-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850270/000095017024124585/prok-20241112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T02:14:04.142269+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"}