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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 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).
Akebia Therapeutics (Nasdaq: AKBA) announced its participation in several virtual investor conferences throughout September 2020. Key appearances include John P. Butler (CEO) at Citi's 15th Annual BioPharma Conference on September 9, and at the Morgan Stanley Global Healthcare Conference on September 15. Michel Dahan (COO) and David Spellman (CFO) will join a fireside chat at H.C. Wainwright's Global Investment Conference on September 14. Akebia aims to enhance the lives of those affected by kidney disease, presenting insights into its business strategy during these engagements.
Akebia Therapeutics (Nasdaq: AKBA) announced top-line results from the PRO2TECT Phase 3 study, which evaluated the efficacy and safety of vadadustat for treating anemia due to chronic kidney disease (CKD) in non-dialysis patients. While vadadustat demonstrated non-inferiority in hemoglobin levels compared to darbepoetin alfa, it did not meet the primary safety endpoint concerning major adverse cardiovascular events (MACE), raising concerns about its approval path. The company plans to submit a New Drug Application to the FDA in 2021 and continue collaboration with Otsuka for European approval.
On September 2, 2020, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to 10 new employees. The options, totaling 54,000 shares, were granted as inducements for employment and have an exercise price of $10.41 per share, equal to the stock's closing price on the grant date. The stock options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly. This action complies with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announces the commercial availability of VAFSEO (vadadustat) in Japan for treating anemia due to chronic kidney disease (CKD). Approved by the Ministry of Health, Labour and Welfare in June 2020, VAFSEO is now listed in the Japan National Health Insurance drug price listing. With an estimated 13 million affected by advanced CKD in Japan, this oral treatment aims to set a new standard of care. Akebia stands to gain up to $190 million in milestone payments from Mitsubishi Tanabe Pharma Corporation and will receive royalties of up to 20% on sales.
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