---
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"
generated_at: "2026-05-18T09:08:01.422879+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ProKidney reports statistically significant Phase 2 REGEN-007 results for rilparencel; FDA Type B meeting set

## Summary
- 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.

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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-094445
- JSON: https://secwatch.observer/filing/0000950170-25-094445.json
- Plain text: https://secwatch.observer/filing/0000950170-25-094445.txt

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