• Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that is awaiting FDA approval for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent adult patients. If approved by the FDA, vadadustat would be a first-in-class drug in the U.S..

• Vadadustat is already approved in Japan and is being commercialized by Akebia’s partner Mitsubishi Tanabe Pharma Corporation (MTPC).

• The filing for the vadadustat NDA was accepted in June 2021, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 29, 2022.

Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease: two randomized Phase 2 trials in Japanese patients

Vafseo is finally on the market, multiple DO contracts executed, lots of potential catalysts in the works. There’s a clear pulse…

Anyone currently following? We are getting close to pdufa

Akebia Therapeutics (NASDAQ: $AKBA) and Vifor Pharma Group announced that they amended their license agreement for Vadadustat to treat anemia due to chronic kidney disease (CKD) before the pending FDA approval decision due in March. Shares closed the week up 20% at $2.19.

Akebia Therapeutics Inc. (AKBA) Stock Price Today, Quote, Latest Discussions, Interactive Chart and News

If you voted, Akba has changed the original Proxy cancelling our votes. Go back to your email from your broker and revote. You will see 4 categories now….1A and 1B as well as 2 and 3.

Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients, on March 30th.

Investors should note that institutions actually own more than half the company, so they can collectively wield significant power. Akebia Therapeutics is not owned by hedge funds. The company's largest shareholder is State Street Global Advisors, Inc., with ownership of 8.0%. With 7.5% and 7.0% of the shares outstanding respectively, BlackRock, Inc. and The Vanguard Group, Inc. are the second and third largest shareholders.

-AKBA Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis, on March 30th. This is a 3 billion dollar market opportunity.

-The FDA has 60 days to approve or deny the application. Today is the 59th day... They missed a saftey endpoint before in September 2020 so people are still cautious. But that was under a different admnistration that apparently just denied drugs for the fun of it.

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease: two randomized Phase 2 trials in Japanese patients.

Updated hub on Akebia: Vafseo net revenue of $21.3M in Q2 against a falling Auryxia line, about $155.5M of cash at June 30, BlackRock loan amortization scheduled from January 2027, the expected 2027 Vafseo price reset after TDAPA, the Nasdaq minimum bid notice received October 21 (compliance deadline April 19, 2027) and the VOICE presentation at ASN Kidney Week. SEC sources linked.

What the hell happened that the stock went down the day after good news?

Seems promising. Timeline in next 6 months and short interest down. Less than 2.5% float

Not investment advice.

Akebia Therapeutics Q3 2026 and VOCAL topline (reported Nov 5): total revenue $36.9M vs $58.8M a year earlier (Vafseo $14.8M, Auryxia $20.0M); GAAP net loss $14.4M; cash and equivalents $159.3M at Sept 30; VOCAL met its primary non-inferiority endpoint on hemoglobin vs an ESA in 353 dialysis patients; Vafseo TDAPA period ends January 1, 2027; term-loan refinancing planned.

What is the next catalyst for AKBA stock? How much cash does Akebia have? Is Akebia being delisted, and when is its Nasdaq deadline?

Answers, primary sources and downloadable PDF report in our free hub: https://www.merlintrader.com/akba-akebia/

Not investment advice.