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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 announced the appointment of Ron Frieson to its Board of Directors, enhancing the company's focus on improving patient outcomes in kidney disease. Frieson, currently COO at Children's Healthcare of Atlanta, brings over 20 years of experience in healthcare and public policy. His expertise in health equity and access is viewed as crucial for Akebia's mission. CEO John P. Butler expressed confidence in Frieson's ability to drive operational improvements and address healthcare disparities, especially impacting underserved populations.
Akebia Therapeutics (Nasdaq: AKBA) announced that its collaborator, Otsuka Pharmaceutical, submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat. This investigational oral treatment targets anemia associated with chronic kidney disease (CKD) in adults. The application marks a significant milestone towards providing a new treatment option for CKD patients in Europe. Vadadustat mimics altitude effects to boost red blood cell production. If approved, Akebia plans to support its commercial launch in Europe.
Akebia Therapeutics (Nasdaq: AKBA) will release its third-quarter financial results on November 4, 2021. A conference call is scheduled for November 9, 2021, at 9:00 a.m. ET to discuss these results and highlight upcoming presentations at the American Society of Nephrology Kidney Week. The call will include discussions on the global Phase 3 data for vadadustat, which is under FDA review with a PDUFA date of March 29, 2022 for treating anemia related to chronic kidney disease.
Akebia Therapeutics is committed to improving the lives of kidney disease patients through innovative therapies. Their product, Auryxia, is FDA-approved for managing phosphorus levels in CKD patients on dialysis and treating iron deficiency anemia in those not on dialysis. However, a lawsuit against CMS seeking Medicare coverage for Auryxia was dismissed. Despite setbacks, Akebia is exploring legislative solutions for coverage restoration. The company's commitment to health equity remains strong, supported by various organizations advocating for patient access to critical treatments.
Akebia Therapeutics (Nasdaq: AKBA) announced that vadadustat efficacy and safety data will be showcased at the ASN Kidney Week 2021 from November 4-7, 2021. Vadadustat, an oral HIF-PH inhibitor, is under FDA review with a PDUFA date of March 29, 2022. The presentation includes multiple abstracts highlighting vadadustat's potential in treating anemia due to chronic kidney disease. Additionally, Akebia will present data on Auryxia, exploring its effectiveness in preventing renal failure in CKD patients.
Akebia Therapeutics (Nasdaq: AKBA) granted stock options to 17 newly-hired employees on September 30, 2021. The options, totaling 180,000 shares, have an exercise price of $2.88 per share, equal to the stock's closing price on that date. Each option vests over four years, beginning with 25% on the first anniversary of the grant, and is subject to continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent in the biopharmaceutical sector focused on kidney disease.
On September 1, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to nine new employees, totaling 89,000 shares. The options, with an exercise price of $2.94 per share, align with Nasdaq Listing Rule 5635(c)(4) and will vest over four years. 25% will vest on the first anniversary, with the remainder vesting quarterly, contingent on continued service. This strategic move is aimed at incentivizing new hires in the biopharmaceutical sector focused on kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced a series of investor conference participations. CEO John P. Butler and CFO David A. Spellman will partake in three significant conferences this September, including the Morgan Stanley Global Healthcare Conference on September 9, H.C. Wainwright Global Investment Conference on September 13, and Cantor Fitzgerald Global Healthcare Conference on September 27. These events aim to update investors about Akebia's progress in developing therapeutics for kidney disease. Live webcasts of these events will be available on the company's investor relations website.
Akebia Therapeutics (AKBA) reported a net loss of $83.0 million for Q2 2021, an improvement from a loss of $175.8 million in Q2 2020. Total revenue decreased to $52.9 million from $90.1 million year-over-year, primarily due to lower collaboration revenue, which fell to $20.0 million from $59.4 million. Net product revenue for Auryxia rose to $33.0 million, a 7.4% increase. Akebia announced FDA acceptance of the vadadustat NDA with a PDUFA date of March 29, 2022, indicating potential market opportunities in treating anemia due to chronic kidney disease.
Akebia Therapeutics granted stock options to 14 newly-hired employees, totaling 95,000 shares at an exercise price of $2.47 per share, equivalent to the stock’s closing price on the grant date, July 30, 2021. The stock options will vest over four years, with 25% vesting after the first year and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), reflecting Akebia's commitment to attracting talent in the biopharmaceutical sector focusing on kidney disease treatment.
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