Welcome to our dedicated page for Akebia Therapeutics news (Ticker: AKBA), a resource for investors and traders seeking the latest updates and insights on Akebia Therapeutics stock.
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 September 1, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to nine new employees, totaling 89,000 shares. The options, with an exercise price of $2.94 per share, align with Nasdaq Listing Rule 5635(c)(4) and will vest over four years. 25% will vest on the first anniversary, with the remainder vesting quarterly, contingent on continued service. This strategic move is aimed at incentivizing new hires in the biopharmaceutical sector focused on kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced a series of investor conference participations. CEO John P. Butler and CFO David A. Spellman will partake in three significant conferences this September, including the Morgan Stanley Global Healthcare Conference on September 9, H.C. Wainwright Global Investment Conference on September 13, and Cantor Fitzgerald Global Healthcare Conference on September 27. These events aim to update investors about Akebia's progress in developing therapeutics for kidney disease. Live webcasts of these events will be available on the company's investor relations website.
Akebia Therapeutics (AKBA) reported a net loss of $83.0 million for Q2 2021, an improvement from a loss of $175.8 million in Q2 2020. Total revenue decreased to $52.9 million from $90.1 million year-over-year, primarily due to lower collaboration revenue, which fell to $20.0 million from $59.4 million. Net product revenue for Auryxia rose to $33.0 million, a 7.4% increase. Akebia announced FDA acceptance of the vadadustat NDA with a PDUFA date of March 29, 2022, indicating potential market opportunities in treating anemia due to chronic kidney disease.
Akebia Therapeutics granted stock options to 14 newly-hired employees, totaling 95,000 shares at an exercise price of $2.47 per share, equivalent to the stock’s closing price on the grant date, July 30, 2021. The stock options will vest over four years, with 25% vesting after the first year and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), reflecting Akebia's commitment to attracting talent in the biopharmaceutical sector focusing on kidney disease treatment.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) has announced that it will release its financial results for the second quarter ended June 30, 2021, on August 5, 2021, before markets open. The company will also host a conference call at 9:00 a.m. ET on the same day to discuss the results and recent business developments. Interested parties can listen live by calling (877) 458-0977 domestically or (484) 653-6724 internationally. A replay will be available after the call until August 11, 2021.
Akebia Therapeutics (Nasdaq: AKBA) announced on July 1, 2021, that it granted stock options to 25 new employees, totaling 210,000 shares. These options, priced at $3.79 per share, are in accordance with Nasdaq Listing Rule 5635(c)(4). The options vest over four years, with 25% unlocking after the first anniversary and the remainder vesting quarterly, contingent upon the employees' continued service. Akebia is dedicated to improving the lives of individuals affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced upcoming presentations of data from its Phase 3 program for vadadustat at the ERA-EDTA Virtual Congress 2021 from June 5-8, 2021. The abstracts are available online in Nephrology Dialysis Transplantation. Key presentations will focus on the hematologic efficacy of vadadustat for anemia in both dialysis-dependent patients and those with non-dialysis-dependent chronic kidney disease. Vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved in Japan but not yet in the U.S.
On June 2, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 15 new employees totaling 121,000 shares. The options were issued as inducements for employment and have an exercise price of $3.51, equivalent to the stock's closing price on the grant date. Vesting occurs over four years, with 25% vesting after one year and the remainder quarterly, contingent on continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) and Otsuka Pharmaceutical have announced the FDA's acceptance of their New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD). This application targets adult patients both on and off dialysis. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) action date of March 29, 2022. The companies emphasize their commitment to bringing this new oral treatment option to patients, with ongoing collaborations for commercial launch preparations.
Akebia Therapeutics® (Nasdaq: AKBA) reported Q1 2021 financial results, showing total revenue of $52.3 million, a decline from $88.5 million in Q1 2020. Collaboration revenue fell to $21.9 million from $59.3 million last year, while net product revenue increased by 4% to $30.4 million. The net loss widened to $69.6 million from $60.7 million. Notably, the NDA for vadadustat was submitted to the FDA, a key milestone for the company. Cash reserves remain strong at $272.8 million, expected to fund operations beyond the anticipated U.S. launch of vadadustat.
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