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.
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.
Akebia Therapeutics (Nasdaq: AKBA) announced plans to release its financial results for Q4 and full-year 2021 on March 1, 2022. The company will not host a conference call prior to the March 29, 2022 PDUFA date for vadadustat, an investigational drug under FDA review for treating anemia due to chronic kidney disease. Vadadustat is already approved in Japan for similar indications. The company aims to improve the lives of those affected by kidney disease.
On February 1, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 17 new employees, totaling 129,000 shares. The exercise price of these options is $1.99 per share, which corresponds with the closing stock price on the grant date, January 31, 2022. Options will vest over four years, beginning with 25% after one year. This move aims to incentivize the new hires as part of Akebia's ongoing strategy to enhance its workforce and improve outcomes in kidney disease treatment.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on improving the lives of those affected by kidney disease, will have its Chief Financial Officer, David Spellman, participate in a virtual fireside chat at the H.C. Wainwright Bioconnect Conference from January 10-13, 2022. An audio replay of the conversation will be available on the Investors section of Akebia's website for 90 days post-conference. Founded in 2007 and headquartered in Cambridge, MA, Akebia is dedicated to developing therapeutics for kidney patients.
On January 4, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to eight newly-hired employees, totaling 49,000 shares. The options have an exercise price of $2.26 per share, in line with the stock's closing price on the grant date, December 31, 2021. The vesting period spans four years, with 25% vesting after the first anniversary and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), aimed at incentivizing new talent in the biopharmaceutical sector focused on kidney disease.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, announced that CEO John P. Butler will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 4:30 p.m. ET. The presentation will be virtual, and an audio replay will be available on Akebia's investor website for 30 days post-event. Founded in 2007 and headquartered in Cambridge, Massachusetts, Akebia aims to enhance the lives of those impacted by kidney disease.
Akebia Therapeutics (AKBA) announced the grant of stock options to 21 newly hired employees on November 30, 2021, totaling 85,000 shares. The exercise price is set at $2.71, equivalent to the closing stock price on the grant date. Each option vests over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on continued employment. The grants comply with Nasdaq Listing Rule 5635(c)(4).
FAQ
What is the current stock price of Akebia Therapeutics (AKBA)?
What is the market cap of Akebia Therapeutics (AKBA)?
What does Akebia Therapeutics, Inc. specialize in?
What is vadadustat?
Is vadadustat approved by the FDA?
What are Akebia’s approved products?
What recent financial moves has Akebia made?
What is Auryxia?
Where is Akebia Therapeutics located?
When was Akebia founded?
What are Akebia’s new pipeline programs?
How has Auryxia performed financially?
