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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) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the approval of Vafseo™ (vadadustat) for treating symptomatic anemia in adults with CKD on chronic dialysis. The decision from the European Commission (EC) is expected within two months and is applicable in all EU member states plus Iceland, Norway, and Liechtenstein.
The CHMP's recommendation is based on comprehensive data from over 7,500 patients, demonstrating the drug's efficacy and safety in clinical trials. The positive opinion is crucial for Akebia's goal to partner in Europe for Vafseo's commercialization.
Akebia Therapeutics (NASDAQ: AKBA) announced an update regarding its drug vadadustat aimed at treating anemia due to chronic kidney disease. The FDA provided a second interim response to Akebia's Formal Dispute Resolution Request linked to the Complete Response Letter previously received in March 2022. Due to staffing constraints, the appeal's oversight has shifted to Dr. Peter Stein, Director at the Office of New Drugs. Akebia anticipates a decision within thirty days post Dr. Stein’s consultations with nephrology and cardiology experts.
On February 1, 2023, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to three newly-hired employees. A total of 18,000 shares were awarded as inducements for joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.63 per share, matching Akebia's closing stock price on the grant date. The options will vest over four years, with 25% vesting on the first anniversary and the rest vesting quarterly, contingent upon continued employment. These options have a 10-year term, governed by Akebia's inducement award program and related agreements.
Akebia Therapeutics (Nasdaq: AKBA) announced an interim response from the FDA regarding its Formal Dispute Resolution Request about vadadustat, aimed at treating anemia in chronic kidney disease. Following a meeting in November, Akebia will provide additional information to the FDA by January 2023, anticipating a response within 30 days post-submission. Vadadustat remains under review in Europe, while it is already approved in Japan for similar indications.
On December 2, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to a newly-hired employee, totaling 3,000 shares. These options have an exercise price of $0.27 per share, matching the closing stock price on the grant date of November 30, 2022. The options vest over four years, with 25% vesting after one year, while the remaining 75% vest quarterly, contingent on the employee's continued service. This action complies with Nasdaq Listing Rule 5635(c)(4), indicating Akebia’s commitment to attract talent.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced its participation in the Piper Sandler 34th Annual Healthcare Conference, scheduled for November 29 to December 1, 2022, in New York City. CEO John P. Butler will engage in a fireside chat on November 29 at 2:30 p.m. ET. A webcast of this session will be accessible for 90 days via the Investors section of Akebia's website. Founded in 2007 and headquartered in Cambridge, Massachusetts, Akebia focuses on developing therapeutics for kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) reported Q3 2022 financial results with net product revenue from Auryxia® reaching $42.2 million, a 14.9% year-over-year increase. The company affirmed its 2022 revenue guidance for Auryxia between $170 - $175 million. Akebia submitted a Formal Dispute Resolution Request to the FDA regarding the Complete Response Letter for vadadustat, anticipating clarity on regulatory approval timelines. The quarterly net loss decreased to $51.9 million, and cash resources of $144.8 million are expected to sustain operations for at least a year.
Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to five new employees, totaling 30,000 shares, on October 31, 2022. The options, priced at $0.25 per share, equal the closing price on the grant date and will vest over four years, with 25% vesting after the first year and the remainder quarterly. This inducement was made in compliance with Nasdaq Listing Rule 5635(c)(4). Akebia aims to enhance the lives of those affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced it will release its Q3 2022 financial results on November 3, 2022, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results and recent company developments. The conference call can be accessed through a registration link provided in the announcement. Akebia, based in Cambridge, Massachusetts, is focused on improving the lives of those impacted by kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced its participation in ASN Kidney Week 2022, taking place from November 3-6 in Orlando. The company will present a poster titled "Prevalence of Hyporesponse to Erythropoiesis-Stimulating Agents Among Medicare Patients with CKD-Related Anemia" on November 3 from 10:00 a.m. to 12:00 p.m. EDT. Attendees can visit Akebia at Booth #1721 for more information. Founded in 2007 and based in Cambridge, Massachusetts, Akebia focuses on developing therapeutics for kidney disease.
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