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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.
Akebia Therapeutics (AKBA) has received marketing authorization from the European Commission for Vafseo™ (vadadustat), an oral treatment for symptomatic anaemia associated with chronic kidney disease (CKD) in adults on dialysis. This approval, effective across all 27 EU member states along with Iceland, Norway, and Liechtenstein, is a significant milestone for Akebia and aims to assist over 200,000 dialysis patients in Europe. Vafseo is available in 150 mg, 300 mg, and 450 mg film-coated tablets, providing an alternative treatment option. The approval follows a favorable opinion from the European Medicines Agency in February 2023 and is based on a robust clinical program involving over 7,500 patients. Akebia plans to partner with a European entity to expedite the drug's availability to patients in need.
Akebia Therapeutics, a biopharmaceutical company focused on kidney disease, announced a stockholder information session on April 21, 2023, at 8:00 a.m. ET. The meeting aims to discuss a proposed reverse stock split to comply with Nasdaq's minimum bid price rule and avoid delisting. A special meeting on May 4, 2023, will allow stockholders to vote on this proposal. Stockholders are encouraged to submit questions by April 19 and can register for the webcast on Akebia's website. They can also vote online, by phone, or by mail, with instructions provided in the revised proxy materials sent on March 17, 2023. Participation is critical for stockholders, as the board recommends voting 'FOR' the proposals to ensure compliance and enhance company stability.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced the adjournment of its special meeting of stockholders originally scheduled for April 11, 2023. The meeting will reconvene on May 4, 2023, at 10:00 a.m. Eastern Time. The adjournment allows the company to gather additional proxies necessary for voting on proposals in its revised definitive proxy statement filed on March 17, 2023. Stockholders are encouraged to vote by May 3, 2023, as the board recommends voting 'FOR' all proposals. Proxies submitted prior will remain valid unless revoked. The meeting's record date remains February 16, 2023, and details are available on the SEC and proxy voting websites.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced its participation in the National Kidney Foundation (NKF) Spring Clinical Meetings 2023, taking place from April 11 to April 15 in Austin, Texas. During this event, Akebia will present posters focusing on critical research related to kidney disease, highlighting topics such as inpatient admission and mortality rates among Medicare patients with dialysis-dependent chronic kidney disease (CKD) and blood transfusion rates. The company aims to enhance the lives of individuals affected by kidney disease and is committed to showcasing its findings at this prominent clinical forum. Attendees can visit Akebia's booth (#801) to learn more about their initiatives and research findings.
On April 4, 2023, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to a new employee, totaling 4,000 shares. The options were provided as an inducement for the employee's recruitment and adhere to Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.56 per share, matching the stock's closing price on the grant date. These options will vest over a period of four years, with a quarter vesting on the first anniversary. Each option has a term of ten years and is governed by Akebia's stock option agreement.
Akebia Therapeutics (Nasdaq: AKBA) reported positive top-line results from the FO2CUS study, evaluating vadadustat for treating anemia in hemodialysis patients. The study demonstrated that vadadustat met both primary and secondary efficacy endpoints, proving non-inferiority to the long-acting erythropoiesis-stimulating agent (ESA), Mircera, when used three times weekly. Additionally, vadadustat exhibited a safety profile comparable to Mircera. The trial involved 456 patients, with results indicating sufficient management of hemoglobin levels, suggesting potential as an oral alternative for current treatment options.
Akebia Therapeutics (Nasdaq: AKBA) announced a meeting with the FDA regarding a Formal Dispute Resolution related to a Complete Response Letter received for its drug vadadustat in March 2022. The meeting involved discussions with Dr. Peter Stein, who is overseeing the appeal process. Akebia anticipates a response from the FDA within thirty days after Dr. Stein's internal consultations conclude, likely in the second quarter of 2023. Vadadustat is aimed at treating anemia associated with chronic kidney disease but is still pending FDA approval.
Akebia Therapeutics (NASDAQ: AKBA) announced a revised definitive proxy statement for a special meeting on April 11, 2023. The main agenda is to seek shareholder approval for a reverse stock split aimed at regaining compliance with Nasdaq's minimum bid price rule, thus avoiding delisting. The proposal also includes a proportional decrease in authorized shares and a potential increase in authorized shares. The company's board strongly recommends approval, citing the critical nature of maintaining a Nasdaq listing for liquidity and shareholder value. The revised proxy card must be used for voting.
Akebia Therapeutics (Nasdaq: AKBA) reported a net product revenue of $177.1 million for 2022, a 24.5% increase from 2021. The company anticipates potential Marketing Authorization for its drug Vafseo™ (vadadustat) in Europe by May 2023 after receiving a positive opinion from the CHMP. For 2023, Akebia set a revenue guidance of $175-$180 million for Auryxia, although it remains cautious regarding the phosphate binder market recovery due to ongoing COVID-19 impacts. Significant operational improvements were made, including a restructuring of the supply chain which reduced costs.
Akebia Therapeutics (NASDAQ: AKBA) will release its financial results for the fourth quarter and full-year ended December 30, 2022, on March 9, 2023, before market opening. The company aims to improve the lives of those affected by kidney disease and plans to host a conference call at 8:30 a.m. ET on the same day to discuss its results and business updates. Interested parties can access the call via a registration link or through a live webcast on Akebia's website. The company emphasizes its commitment to innovation in kidney disease therapeutics.
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