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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 (Nasdaq: AKBA) announced the grant of stock options to three new employees totaling 14,000 shares on May 31, 2022. The options, which have an exercise price of $0.37 per share, align with Nasdaq Listing Rule 5635(c)(4). The stock options will vest over four years, with 25% vesting after the first year and the remaining 75% vesting quarterly, contingent on continued employment. Akebia, based in Cambridge, Massachusetts, focuses on biopharmaceutical solutions for kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company dedicated to improving the lives of those affected by kidney disease, will have CEO John Butler participate in a fireside chat at the H.C. Wainwright Global Investment Conference, scheduled for May 23–26, 2022. An audio replay of the chat will be accessible through Akebia's investor relations webpage starting on May 24 for approximately 90 days. Founded in 2007 and based in Cambridge, Massachusetts, Akebia focuses on developing and commercializing therapeutics for kidney disease.
Akebia Therapeutics (AKBA) reported a 36% increase in net Auryxia revenue, totaling $41.4 million in Q1 2022. Total revenue reached $61.7 million, up from $52.3 million a year earlier. The company provided 2022 revenue guidance for Auryxia of $165 million to $170 million. Despite a Complete Response Letter from the FDA regarding vadadustat, Akebia aims to focus on Auryxia's commercial success and explore earlier-stage assets. The cash position stands at $174.6 million.
Akebia Therapeutics (Nasdaq: AKBA) plans to release its first-quarter financial results for 2022 on May 9, 2022, after market close. The company will hold a conference call at 4:30 p.m. ET to discuss these results and provide a business update. Participants can join the call via phone or listen live on Akebia's website. A replay will be available shortly after the call concludes, lasting until May 15, 2022. Akebia focuses on developing therapeutics for individuals affected by kidney disease.
On April 6, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the National Kidney Foundation Spring Clinical Meetings 2022 in Boston, scheduled for April 6-10, 2022. The company will present three significant posters focusing on real-world healthcare costs, adherence to phosphate binders, and thrombotic events in dialysis-dependent patients. Notably, Vadadustat, an investigational drug for chronic kidney disease anemia, received a complete response letter from the FDA on March 29, 2022, while still under review by the European Medicines Agency.
On April 4, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to nine newly-hired employees, totaling 53,000 shares. Each option has an exercise price of $0.72, matching the closing stock price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on continued employment. The grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to strengthen employee retention and incentivize performance.
Akebia Therapeutics (Nasdaq: AKBA) announced that the FDA has issued a complete response letter (CRL) for its New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD). The FDA cited safety concerns, including a failure to demonstrate non-inferiority in major adverse cardiovascular events in non-dialysis patients, and risks of thromboembolic events and liver injury. Akebia plans to discuss next steps with partners and the FDA. Vadadustat remains under review in Europe and is approved in Japan for CKD-related anemia.
Akebia Therapeutics (Nasdaq: AKBA) granted stock options for 97,000 shares to 12 newly-hired employees on February 28, 2022. The exercise price is set at $2.16 per share, matching the stock's closing price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly, contingent on the employees' continued service. This grant adheres to Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent joining the company focused on kidney disease therapeutics.
Akebia Therapeutics (Nasdaq: AKBA) reported its financial results for Q4 and FY 2021, highlighting a total revenue of $59.6 million for Q4, up from $56.7 million in Q4 2020, and $213.6 million for 2021, down from $295.3 million in 2020. The net product revenue for Auryxia was $142.2 million, a 10% increase year-over-year. Akebia aims for a significant catalyst with the upcoming PDUFA date of March 29, 2022, for its drug vadadustat, which may transform treatment options for anemia due to CKD if approved.
On February 22, 2022, Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced an amended license agreement with Vifor Pharma to enable the sale of vadadustat, an investigational treatment for anemia due to chronic kidney disease (CKD). This amendment expands Vifor's access to U.S. dialysis patients, anticipated to support a U.S. launch following vadadustat's FDA PDUFA date of March 29, 2022. Vifor will invest $20 million equity and provide $40 million for working capital. Akebia will retain 66% of the profits from sales, sharing others with Otsuka in the non-dialysis market.
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