Allison Bratzel

Roger Song

Antonio Arce

Ed Arce

Leszek Sulewski

Mazahir Alimohamed

Roanna Clarissa Ruiz

- Akebia Therapeutics announced on **October 28, 2025**, that it will **not initiate the VALOR clinical trial** for Vafseo (vadadustat) to treat anemia in **non-dialysis dependent chronic kidney disease (CKD) patients**.  **[1517022_0001517022-25-000040_regulatoryupdate_10282025x.htm:0]** **[1517022_0001517022-25-000040_akba-20251028.htm:1]** **[1517022_0001517022-25-000040_akba-20251028.htm:2]** 
- This decision follows feedback from the U.S. FDA, indicating that regulatory alignment for such a trial would require a **significantly larger number of patients, more time, and cost** than initially proposed.  **[1517022_0001517022-25-000040_regulatoryupdate_10282025x.htm:0]** 
- Consequently, Akebia **does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients**, a decision the company believes is in the **best interests of its shareholders**.  **[1517022_0001517022-25-000040_regulatoryupdate_10282025x.htm:0]** 
- Akebia will continue its efforts to establish Vafseo as the standard of care for **patients on dialysis**, for whom the drug is already approved in the U.S. and 37 other countries.  **[1517022_0001517022-25-000040_regulatoryupdate_10282025x.htm:0]**

Akebia Therapeutics Will Not Pursue Broad Vafseo Label for Non-Dialysis CKD Patients

- Akebia Therapeutics will **not initiate the VALOR clinical trial** for vadadustat to treat anemia in late-stage chronic kidney disease (CKD) patients not on dialysis.  **[1517022_d97c2a9f657044d089e5078b1780c1b4_0]** 
- This decision means the company **does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients**.  **[1517022_d97c2a9f657044d089e5078b1780c1b4_0]** 
- The decision follows feedback from the FDA, indicating that regulatory alignment for such a trial would require a significantly larger number of patients, more time, and higher costs than initially proposed.  **[1517022_d97c2a9f657044d089e5078b1780c1b4_0]** 
- Akebia's CEO, John P. Butler, stated that this decision is in the **best interests of shareholders**.  **[1517022_d97c2a9f657044d089e5078b1780c1b4_0]** 
- The company will continue to focus on making Vafseo standard of care for **patients on dialysis**, for whom it is already approved in the U.S. and began being prescribed in **January 2025**.  **[1517022_d97c2a9f657044d089e5078b1780c1b4_0]**

Akebia Therapeutics (AKBA)