Akebia股价暴跌，放弃Vafseo，转而支持非透析患者

2025-10-29 05:45

After the US FDA rebuffed its plans on a trial design, Akebia Therapeutics (NASDAQ: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 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 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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