Akebia Therapeut Stock Price, News & Analysis

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.

Akebia Therapeutics (NASDAQ: AKBA) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the approval of Vafseo™ (vadadustat) for treating symptomatic anemia in adults with CKD on chronic dialysis. The decision from the European Commission (EC) is expected within two months and is applicable in all EU member states plus Iceland, Norway, and Liechtenstein.

The CHMP's recommendation is based on comprehensive data from over 7,500 patients, demonstrating the drug's efficacy and safety in clinical trials. The positive opinion is crucial for Akebia's goal to partner in Europe for Vafseo's commercialization.

Akebia Therapeutics (NASDAQ: AKBA) announced an update regarding its drug vadadustat aimed at treating anemia due to chronic kidney disease. The FDA provided a second interim response to Akebia's Formal Dispute Resolution Request linked to the Complete Response Letter previously received in March 2022. Due to staffing constraints, the appeal's oversight has shifted to Dr. Peter Stein, Director at the Office of New Drugs. Akebia anticipates a decision within thirty days post Dr. Stein’s consultations with nephrology and cardiology experts.