---
schema_version: "secwatch.filing_event.v1"
accession: "0001517022-25-000040"
form_type: "8-K"
ticker: "AKBA"
cik: "0001517022"
company_name: "Akebia Therapeutics, Inc."
filed_at: "2025-10-28T23:59:59+00:00"
generated_at: "2026-05-17T01:55:29.606998+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Akebia abandons Vafseo broad label pursuit for non-dialysis CKD after FDA alignment failure

## Summary
- Akebia will not initiate the VALOR trial for vadadustat in late-stage CKD not on dialysis after FDA feedback.
- FDA indicated the trial would require significantly more patients and meaningfully more time and cost.
- Akebia does not expect to pursue a broad label for Vafseo for non-dialysis dependent CKD patients.
- Vafseo remains approved only for anemia in dialysis-dependent CKD patients; launched in U.S. Jan 2025.
- Akebia is encouraged by FDA discussion on smaller subgroups but no specific path forward yet.

## SEC filing metadata
- accession: 0001517022-25-000040
- form_type: 8-K
- ticker: AKBA
- cik: 0001517022
- company_name: Akebia Therapeutics, Inc.
- filed_at: 2025-10-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1517022/000151702225000040/0001517022-25-000040-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1517022/000151702225000040/akba-20251028.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001517022-25-000040
- JSON: https://secwatch.observer/filing/0001517022-25-000040.json
- Plain text: https://secwatch.observer/filing/0001517022-25-000040.txt

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