FDA Pushback Prompts Akebia To Drop Broad Label Pursuit For Kidney Disease Drug

Author: Vandana Singh | October 29, 2025 01:13pm

Akebia Therapeutics Inc. (NASDAQ:AKBA) stock is trading lower on Wednesday.

The kidney disease company met with the U.S. Food and Drug Administration (FDA) and has not reached an agreement on a path forward for the VALOR trial design, which involves the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) who are not on dialysis.

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As a result, Akebia does not plan to initiate VALOR and therefore does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients.

In the U.S., Vafseo (vadadustat) is approved for anemia due to CKD in adults receiving dialysis for at least three months. Nephrologists in the U.S. began prescribing Vafseo to patients in January 2025.

Akebia recently completed a Type C meeting with the FDA. While Akebia has not yet received final meeting minutes from the face-to-face Type C meeting, based on the FDA feedback, Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed, and accordingly would require meaningfully more time and cost to complete.

“..we are disappointed in the outcome of the meeting,” said John P. Butler, Chief Executive Officer at Akebia. “We believe our decision not to pursue a broad NDD-CKD label, based on our discussion with the FDA, is in the best interests of our shareholders.”

AKBA Price Action: Akebia Therapeutics shares were down 25.71% at $2.29 at the time of publication on Wednesday, according to Benzinga Pro data.

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Posted In: AKBA