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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.
On February 2, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the issuance of stock options to 19 newly hired employees. A total of 161,000 shares will be available at an exercise price of $3.24 per share, matching the stock's closing price on the grant date of January 29, 2021. The options will vest over four years, with 25% vesting after one year and the remainder quarterly, contingent upon continued employment. This grant is part of Akebia's compliance with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the virtual H.C. Wainwright Bioconnect 2021 Conference from January 11-14, 2021. CEO John P. Butler will partake in a fireside chat during the event. Investors can access the recorded presentation starting January 11 on the company's website. Akebia is focused on developing therapeutics for kidney disease, striving to improve the lives of affected individuals. Founded in 2007 and headquartered in Cambridge, Massachusetts, Akebia emphasizes its commitment to kidney health.
Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to eight new employees on December 31, 2020, totaling 89,000 shares with an exercise price of $2.80 per share. This decision aligns with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment. The options vest over four years, with 25% vested after one year and the remainder quarterly. The options are valid for ten years and are governed by the company's Inducement Award Program.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, will participate in the 39th Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for January 13, 2021, at 2:50 p.m. EST, led by John P. Butler, President and CEO. Interested parties can access the live webcast and replay on the Investors section of Akebia's website. Founded in 2007 and based in Cambridge, Massachusetts, Akebia is focused on developing therapeutics for kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced a virtual panel scheduled for December 16, 2020, aimed at discussing hyperphosphatemia management in patients with chronic kidney disease (CKD) on dialysis. The panel will feature insights from kidney care professionals and emphasize the importance of a multidisciplinary care approach and telehealth monitoring. Akebia's AURYXIA® (ferric citrate) is FDA-approved for controlling serum phosphorus levels in CKD patients on dialysis and treating iron deficiency anemia in CKD patients not on dialysis.
Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 7 newly-hired employees on November 30, 2020. The options, totaling 49,000 shares, have an exercise price of $3.31 per share, equivalent to the stock's closing price on the grant date. These options will vest over four years, with 25% vesting after one year and the remainder quarterly, contingent on continued employment. This move adheres to Nasdaq Listing Rule 5635(c)(4) and aims to incentivize the new hires.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease treatments, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 3, 2020. The company’s President, John P. Butler, and CFO, David A. Spellman, will engage in virtual meetings. A recording of their presentation will be accessible on the conference site and Akebia's investor page from November 24 to December 3, 2020. Akebia, founded in 2007 and based in Cambridge, Massachusetts, aims to enhance the quality of life for those affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) has been ranked 10th on Deloitte's Technology Fast 500, reflecting a staggering revenue growth of 21,724% from 2016 to 2019. This rapid growth is attributed to the strategic merger with Keryx Biopharmaceuticals on December 12, 2018, which enabled revenue from the commercial product AURYXIA®. Additionally, Akebia's collaboration revenue from the development of vadadustat, an investigational treatment for anemia due to chronic kidney disease, further supports this growth. The company is recognized for its commitment to improving the lives of kidney disease patients.
Akebia Therapeutics (AKBA) announced the publication of a manuscript in Nephrology Dialysis Transplantation, detailing the study design and methodology of its Phase 3 INNO2VATE program. This research evaluates vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treating anemia due to chronic kidney disease. The manuscript highlights that demographics of study participants align with typical dialysis-dependent CKD patients, suggesting broad applicability of results. Vadadustat met both primary and key secondary efficacy and safety endpoints compared to darbepoetin alfa.
Akebia Therapeutics (Nasdaq: AKBA) announced its Q3 2020 financial results, reporting total revenue of $60 million, down from $92 million in Q3 2019, primarily due to decreased collaboration revenue. Despite a 14.6% increase in net product revenue for Auryxia® to $34.4 million, net loss widened to $60 million from $54.6 million. Akebia completed a pre-NDA meeting with the FDA for vadadustat, an oral treatment for anemia due to chronic kidney disease, targeting a $2 billion market. The company aims to submit an NDA in early 2021.
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