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Akebia Therapeutics, Inc. - AKBA STOCK NEWS

Welcome to our dedicated page for Akebia Therapeutics news (Ticker: AKBA), a resource for investors and traders seeking the latest updates and insights on Akebia Therapeutics stock.

Akebia Therapeutics, Inc. (NASDAQ: AKBA) is a fully integrated biopharmaceutical company headquartered in Cambridge, Massachusetts. Focused on delivering innovative therapies for patients with kidney disease, Akebia leverages hypoxia-inducible factor (HIF) biology in its product development. The company's lead product candidate, vadadustat, is an investigational oral therapy aimed at treating anemia related to chronic kidney disease (CKD) in both non-dialysis and dialysis patients. Akebia's global phase 3 program for vadadustat includes the PRO2TECT studies for non-dialysis patients and the INNO2VATE studies for dialysis-dependent patients. Vadadustat has received approval for the treatment of anemia due to CKD in multiple countries including Japan, Europe, and Australia, and is awaiting U.S. FDA approval with a PDUFA date set for March 27, 2024.

In addition to vadadustat, Akebia's portfolio includes Auryxia (ferric citrate), a medicine approved in the U.S. for the control of serum phosphorus levels in adult patients with dialysis-dependent CKD and the treatment of iron deficiency anemia in adult patients with non-dialysis-dependent CKD. Auryxia continues to show robust performance, with 2023 net product revenues totaling $170.3 million.

Akebia recently strengthened its financial position by securing a loan facility from BlackRock, providing up to $55 million in borrowing capacity. This move is geared towards supporting the potential U.S. launch of vadadustat, which Akebia anticipates will transform the company and provide a new oral treatment option for anemia in dialysis patients.

Current projects include exploring new pipeline programs targeted at acute care settings, such as acute kidney injury and acute respiratory distress syndrome, as well as retinopathy of prematurity in neonates.

With significant partnerships, a strong pipeline, and strategic financial maneuvers, Akebia Therapeutics continues to be a key player in the biopharmaceutical space, dedicated to bettering the lives of individuals affected by kidney disease.

Rhea-AI Summary
Akebia reports Q2 2023 net product revenue of $42.2 million for Auryxia and reaffirms 2023 revenue guidance of $175.0-$180.0 million. Plans to resubmit NDA for vadadustat in Q3 2023. Akebia gains approval for vadadustat in 33 additional countries. Akebia enters exclusive license agreement with Medice. Net loss of $11.2 million for Q2 2023. Cash position of $53.6 million as of June 30, 2023. Akebia identifies accounting errors and material weakness in internal controls.
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Akebia expects to resubmit NDA for vadadustat by Q3 2023, received productive meeting minutes with FDA
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Akebia to release Q2 financial results on August 25th and host conference call at 9:00 a.m. ET
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Akebia Therapeutics, Inc. received a notice of non-compliance from Nasdaq for not timely filing its Form 10-Q. The company plans to release its financial results for Q2 2023 by August 25, 2023, and expects to regain compliance upon filing.
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Akebia Therapeutics, Inc. granted its new Senior Vice President, Chief Financial Officer, and Treasurer, Ellen Snow, options to purchase 560,000 shares of the company's common stock at an exercise price of $1.67 per share. The options vest over four years, with 25% of the shares vesting on the first anniversary of the grant date and the remaining 75% vesting quarterly thereafter, subject to Ms. Snow's continued service with Akebia.
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Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced that CEO John Butler will participate in a fireside chat at the H.C. Wainwright 2nd Annual Kidney Conference to discuss recent regulatory updates regarding vadadustat, Akebia's oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.
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Akebia Therapeutics announced completion of an End of Dispute Type A meeting with the FDA regarding the resubmission of its NDA for vadadustat as a treatment for anemia due to CKD in adult patients on dialysis. The meeting was productive and Akebia plans to resubmit the NDA by the end of Q3 2023.
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Akebia Therapeutics grants two newly-hired employees options to purchase 24,000 shares of common stock.
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FAQ

What is the current stock price of Akebia Therapeutics (AKBA)?

The current stock price of Akebia Therapeutics (AKBA) is $1.88 as of November 22, 2024.

What is the market cap of Akebia Therapeutics (AKBA)?

The market cap of Akebia Therapeutics (AKBA) is approximately 404.7M.

What does Akebia Therapeutics, Inc. specialize in?

Akebia Therapeutics specializes in delivering innovative therapies for patients with kidney disease, leveraging hypoxia-inducible factor (HIF) biology.

What is vadadustat?

Vadadustat is Akebia’s lead product candidate, an investigational oral therapy aimed at treating anemia related to chronic kidney disease in non-dialysis and dialysis patients.

Is vadadustat approved by the FDA?

Vadadustat is currently under review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) date set for March 27, 2024.

What are Akebia’s approved products?

Akebia’s approved products include Auryxia (ferric citrate), which is used for controlling serum phosphorus levels in dialysis-dependent CKD patients and treating iron deficiency anemia in non-dialysis-dependent CKD patients.

What recent financial moves has Akebia made?

Akebia secured a loan facility from BlackRock, providing up to $55 million in borrowing capacity, aimed at supporting the potential U.S. launch of vadadustat.

What is Auryxia?

Auryxia (ferric citrate) is a medication approved in the U.S. for the control of serum phosphorus levels in dialysis-dependent CKD patients and the treatment of iron deficiency anemia in non-dialysis-dependent CKD patients.

Where is Akebia Therapeutics located?

Akebia Therapeutics is headquartered in Cambridge, Massachusetts.

When was Akebia founded?

Akebia Therapeutics was founded in 2007.

What are Akebia’s new pipeline programs?

Akebia is exploring new pipeline programs in acute care settings, including acute kidney injury, acute respiratory distress syndrome, and retinopathy of prematurity in neonates.

How has Auryxia performed financially?

Auryxia reported robust performance with 2023 net product revenues totaling $170.3 million.

Akebia Therapeutics, Inc.

Nasdaq:AKBA

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AKBA Stock Data

404.73M
207.87M
2.09%
27.29%
7.05%
Drug Manufacturers - Specialty & Generic
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