Akebia plummets as it abandons Vafseo for non-dialysis patients

[Red arrow pointing down with declining bar graph on red background]
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* After the US FDA rebuffed its plans on a trial design, Akebia Therapeutics (NASDAQ:AKBA [https://seekingalpha.com/symbol/AKBA]) has decided to abandon efforts to expand the indication for Vafseo (vadadustat) to treat anemia in patients with chronic kidney disease not on dialysis. Shares dropped 19% in after-hours trading Tuesday.
* The company said that it could not come to an agreement with the agency on a design for the VALOR trial.
* The biopharma noted [https://seekingalpha.com/pr/20283297-akebia-therapeutics-provides-update-on-vafseo-for-non-dialysis-patients] that "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."
* Vafseo won [https://seekingalpha.com/news/4084769-akebia-stock-jumps-as-fda-clears-renal-anemia-therapy] FDA approval in 2024 but only for dialysis patients. The drug brought in revenue of $13.3M in Q2. The company reports Q3 financial results before market open on Nov. 6.

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* Akebia Therapeutics: Post-Earnings Dip Looks Like A Discounted Entry Ahead Of A Vafseo Inflection [https://seekingalpha.com/article/4817429-akebia-therapeutics-post-earnings-dip-discounted-entry-ahead-vafseo-inflection]
* Akebia Therapeutics, Inc. (AKBA) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4810658-akebia-therapeutics-inc-akba-q2-2025-earnings-call-transcript]
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* Akebia Q2 2025 Earnings Preview [https://seekingalpha.com/news/4480123-akebia-q2-2025-earnings-preview]