---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-159041"
form_type: "8-K"
ticker: "PROK"
cik: "0001850270"
company_name: "PROKIDNEY CORP."
filed_at: "2025-07-15T23:59:59+00:00"
generated_at: "2026-05-18T06:31:55.719397+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# ProKidney gains FDA alignment on accelerated approval pathway for rilparencel; topline data Q2 2027

## Summary
- FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel in CKD with type 2 diabetes.
- Effect size of at least 1.5 mL/min/1.73m2/year required versus sham; nearly half of required patients enrolled.
- Phase 3 PROACT 1 can serve as both the accelerated and confirmatory study; confirmatory readout timing in 1H 2026.
- Topline data for accelerated approval BLA submission anticipated in Q2 2027.
- Rilparencel holds RMAT designation; CEO called it a critical regulatory milestone.

## SEC filing metadata
- accession: 0001193125-25-159041
- form_type: 8-K
- ticker: PROK
- cik: 0001850270
- company_name: PROKIDNEY CORP.
- filed_at: 2025-07-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1850270/000119312525159041/0001193125-25-159041-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1850270/000119312525159041/d477465d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-159041
- JSON: https://secwatch.observer/filing/0001193125-25-159041.json
- Plain text: https://secwatch.observer/filing/0001193125-25-159041.txt

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