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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, Inc. (Nasdaq: AKBA), dedicated to improving the lives of those with kidney disease, will have its CEO John P. Butler and CFO David A. Spellman participate in several investor conferences. Key events include the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, where Butler will attend a virtual fireside chat, and the 4th Annual Evercore ISI HealthCONx Conference from November 30 to December 2, featuring another fireside chat by Butler on November 30 at 4:45 PM. Webcasts will be available on the company's website.
On November 15, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the Jefferies London Healthcare Conference from November 16-19, 2021. CEO John P. Butler will deliver a presentation, which will be available on-demand starting at 8:00 a.m. GMT on November 18. This presentation can be accessed through the conference site or via the Investors section of Akebia's website for 30 days post-conference. Akebia focuses on developing therapeutics for kidney disease, aiming to improve the lives of affected individuals.
Akebia Therapeutics (AKBA) reported Q3 2021 revenue of $48.8 million, down from $60 million in Q3 2020, primarily due to reduced collaboration revenue from Otsuka. Net product revenue for Auryxia increased by 7% to $36.8 million. The net loss was $59.5 million, slightly better than $60 million a year prior. The company is preparing for the potential U.S. launch of vadadustat, an investigational therapy for CKD-related anemia, with a PDUFA date set for March 29, 2022. Recent milestones include submissions for marketing authorization in Europe and successful completion of key clinical programs.
On November 1, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to three new employees, totaling 11,000 shares. The options were granted on October 29, 2021, at an exercise price of $2.87 per share, equal to the closing stock price on that date. These options will vest over four years, with 25% vesting on the first anniversary and the remainder quarterly thereafter, contingent on continued employment. This grant adheres to Nasdaq Listing Rule 5635(c)(4) and is part of the company's Inducement Award Program.
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.
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