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Akebia Therapeutics, Inc. - AKBA STOCK NEWS

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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.

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Akebia Therapeutics, Inc. (Nasdaq: AKBA) granted two new employees options to purchase 31,000 shares of Akebia's common stock on November 30, 2023. The options have an exercise price of $1.06 per share, vest over four years, and have a 10-year term. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4).
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Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced that CEO John Butler will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on November 28th. The webcast will be available on Akebia's website for 90 days.
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Akebia Therapeutics (AKBA) reported financial results for Q3 2023, with net product revenue of $40.1 million for Auryxia. The company's vadadustat NDA was accepted by the FDA with a PDUFA date set for March 27, 2024. Vadadustat is now approved in 36 countries, including Australia and Taiwan. Akebia also modified its loan agreement with Pharmakon, extending the maturity and deferring principal payments.
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Akebia Therapeutics has amended its loan agreement with Pharmakon Advisors, extending the maturity date to March 2025. Quarterly principal payments have been deferred until October 2024, after which monthly principal payments will begin. The amendment strengthens Akebia's cash position and provides flexibility for a potential vadadustat launch.
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Akebia Therapeutics, Inc. granted one newly-hired employee options to purchase 61,000 shares of Akebia's common stock. The options have an exercise price of $0.88 per share, vest over four years, and have a 10-year term. This grant was made in accordance with Nasdaq Listing Rule 5635(c)(4).
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Akebia Therapeutics® (Nasdaq: AKBA) will release its financial results for Q3 2023 on November 8th. A conference call will be held on the same day at 8:00 a.m. ET to discuss the results and recent business highlights.
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Akebia Therapeutics announces FDA acknowledgment of complete resubmission for vadadustat as a treatment for anemia due to chronic kidney disease. FDA sets user fee goal date for March 27, 2024.
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Akebia Therapeutics to present data at ASN Kidney Week 2023, including alternate dosing for vadadustat in the treatment of anemia due to chronic kidney disease.
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Akebia Therapeutics granted options to purchase 2,000 shares of common stock to a newly-hired employee. The options have an exercise price of $1.14 per share and vest over four years. Each option has a 10-year term.
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Akebia Therapeutics has resubmitted its New Drug Application to the FDA for vadadustat, an oral treatment for anemia due to chronic kidney disease. The resubmission includes post-marketing safety data from Japan. A letter from the FDA acknowledging the resubmission is expected in 30 days, with a PDUFA date set for six months from submission.
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FAQ

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

300.77M
209.60M
1.97%
27.36%
5.87%
Pharmaceutical Preparation Manufacturing
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United States of America
CAMBRIDGE