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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) 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.
On October 3, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options for 50,000 shares to four new employees, as an inducement for their employment. The options, awarded on September 30, 2022, have an exercise price of $0.32 per share, matching the closing stock price on the grant date. These options vest over four years, beginning with 25% on the first anniversary and the remaining 75% quarterly, contingent on the employees' continued service. The announcement complies with Nasdaq Listing Rule 5635(c)(4).
On September 2, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced granting stock options to six new employees, totaling 27,000 shares, as per Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $0.36 per share and will vest over four years, starting with 25% on the first anniversary. This move aims to attract talent crucial for advancing Akebia's mission to improve the lives of those affected by kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) has announced that CEO John Butler will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference, scheduled for September 12–14, 2022. This hybrid conference will feature the presentation available on-demand starting September 12 for 90 days via the Investors section of Akebia's website. Akebia aims to improve the lives of those affected by kidney disease and has been operational since its founding in 2007 in Cambridge, Massachusetts.
Akebia Therapeutics reported Q2 2022 financial results showing a 32.4% increase in net Auryxia® product revenue to $43.7M. The company has raised its 2022 revenue guidance for Auryxia to $170 - $175M. Following the termination of their partnership with Otsuka, Akebia regained full rights to vadadustat, which is under review by the FDA and EMA. Operating expenses have decreased due to strategic cost management. Notably, net income reached $29.3M, a shift from a $83.0M loss a year prior.
Akebia Therapeutics (Nasdaq: AKBA) announced initial findings from the VSTAT trial, evaluating vadadustat for treating ARDS in COVID-19 patients with hypoxemia. The phase 2 study included 449 subjects, but failed to meet its primary endpoint, achieving only a 94% probability of benefit at Day 14. Results showed 13.3% of vadadustat participants reached severe outcome scores compared to 16.9% in the placebo group. Adverse events were similar in both groups, with a 78.6% incidence in vadadustat patients. Akebia plans to review full data and consult the FDA for future development.
On August 2, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to six new employees totaling 26,000 shares. The options were granted as inducements for employment, in line with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.39 per share, equal to the stock's closing price on the grant date. The options will vest over four years, with an initial 25% vesting on the first anniversary and the remainder vesting quarterly, subject to continued service. Each option has a 10-year term.
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