---
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"
generated_at: "2026-06-01T05:23:06.395469+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ProKidney reports REGEN-007 Phase 2 interim: eGFR stable over 18 months; manufacturing resumed

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-157913
- JSON: https://secwatch.observer/filing/0001193125-24-157913.json
- Plain text: https://secwatch.observer/filing/0001193125-24-157913.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.