Akebia Therapeutics Provides Update on Vafseo for Non-Dialysis Patients
Akebia Therapeutics, Inc. (AKBA)
Last akebia therapeutics, inc. earnings: 3/10 07:49 am
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US:NASDAQ Investor Relations:
ir.akebia.com/investor-relations
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Source: GlobeNewswire
CAMBRIDGE, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that after meeting with the U.S. Food and Drug Administration (FDA) it has not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis. 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. 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
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News
- Akebia Therapeutics (NASDAQ:AKBA) had its "buy" rating reaffirmed by analysts at BTIG Research. They now have a $5.00 price target on the stock.MarketBeat
- Akebia Therapeutics (NASDAQ:AKBA) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $6.00 price target on the stock.MarketBeat
- Akebia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Akebia Announces Establishment of Rare Kidney Disease PipelineGlobeNewswire
- Akebia Therapeutics to Present at the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
AKBA
Earnings
- 11/10/25 - In-Line
AKBA
Sec Filings
- 12/1/25 - Form 8-K
- 11/17/25 - Form 8-K
- 11/10/25 - Form 10-Q
- AKBA's page on the SEC website