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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), 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.
On November 3, 2020, Akebia Therapeutics (Nasdaq: AKBA) announced it granted stock options to 6 newly-hired employees, totaling 27,000 shares. The options, priced at $2.22 per share, reflect the company's closing stock price on the grant date of October 30, 2020. Each option vests over four years, with 25% vesting on the first anniversary and the remainder quarterly, conditional on continued employment. These grants align with Nasdaq Listing Rule 5635(c)(4), enhancing the company’s talent acquisition strategy.
Akebia Therapeutics (Nasdaq: AKBA) announced it will release its third-quarter financial results for the period ending September 30, 2020, on November 5, 2020, before market opening. A conference call to discuss these results and business updates will take place at 9:00 a.m. ET on the same day, accessible via phone and webcast. The call will be archived online for later access. Akebia is committed to improving the lives of those with kidney disease and has been operational since 2007, headquartered in Cambridge, Massachusetts.
On October 23, 2020, Akebia Therapeutics (Nasdaq: AKBA) presented clinical data from its PRO2TECT Phase 3 program at ASN Kidney Week. The program assessed the efficacy and safety of vadadustat versus darbepoetin alfa for treating anemia due to chronic kidney disease (CKD) in patients not on dialysis. Vadadustat met its primary and key secondary efficacy endpoints, achieving non-inferiority. However, it failed to meet the primary safety endpoint concerning major adverse cardiovascular events (MACE), although further analysis indicated no significant increase in cardiovascular risk for U.S. patients.
Akebia Therapeutics (Nasdaq: AKBA) presented data from its INNO2VATE Phase 3 program at ASN Kidney Week 2020, highlighting the efficacy and cardiovascular safety of vadadustat for treating anemia in adult dialysis patients. The results showed vadadustat's non-inferiority to darbepoetin alfa across key metrics, including major adverse cardiovascular events (MACE). Akebia aims to submit a New Drug Application (NDA) to the FDA in 2021 and plans to present additional trial results at ASN Kidney Week.
Akebia Therapeutics (Nasdaq: AKBA) announced it will present data from its global Phase 3 programs for vadadustat, targeting anemia due to chronic kidney disease (CKD), at the ASN Kidney Week from October 22-25, 2020. The INNO2VATE program, focusing on patients on dialysis, and the PRO2TECT program for non-dialysis patients will showcase promising results. Vadadustat met primary and key secondary efficacy endpoints in INNO2VATE, while PRO2TECT achieved primary efficacy but failed its primary safety endpoint. Akebia's abstract from PRO2TECT has been selected for a late-breaking presentation.
Akebia Therapeutics (Nasdaq: AKBA) announced on October 2, 2020 that it granted stock options to 11 new employees as an inducement for joining the company. The options amount to 84,000 shares with an exercise price of $2.51 per share, coinciding with the stock's closing price on the grant date. The options vest over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on the employee’s service. This move is in compliance with Nasdaq Listing Rule 5635(c)(4).
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