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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 April 2, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to 19 new employees totaling 131,000 shares to enhance recruitment efforts. These options have an exercise price of $3.38, the same as the stock's closing price on the grant date. Each option vests over four years, with 25% vesting after one year and the remainder quarterly, contingent on continued employment. The options adhere to Nasdaq Listing Rule 5635(c)(4) as part of the company's Inducement Award Program.
Akebia Therapeutics (Nasdaq: AKBA) announced the submission of a New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD) in adult patients, both on and off dialysis. The NDA encompasses data from over 8,000 patients across 36 clinical trials. The FDA has a 60-day window to assess if the NDA is acceptable for review. Further, Akebia is collaborating with Otsuka Pharmaceutical for a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) later this year.
Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the virtual National Kidney Foundation 2021 Spring Clinical Meetings from April 6-10, 2021. The company will present new data including a poster on a Phase 1 study regarding the drug vadadustat, an investigational treatment for anemia due to chronic kidney disease (CKD). Vadadustat's global Phase 3 program is complete, although it is only approved in Japan. Akebia will also support an educational session on CKD-related anemia treatments.
Akebia Therapeutics (Nasdaq: AKBA) announced that its partner, Japan Tobacco Inc. (JT), received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for Riona® Tablets (ferric citrate hydrate) to treat iron deficiency anemia (IDA) in adult patients in Japan. This approval follows the original marketing authorization obtained in 2014 for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients. Akebia's Auryxia® has similar indications in the U.S.
On February 26, 2021, Akebia Therapeutics (Nasdaq: AKBA) granted stock options to five new employees totaling 44,000 shares as part of their employment incentives. The options were priced at $3.46 per share, matching the closing stock price on the grant date. These options will vest over four years, with 25% becoming available on the first anniversary and the remainder vesting quarterly, contingent upon continued employment. This move aligns with Nasdaq Listing Rule 5635(c)(4) and reflects Akebia's commitment to attracting talent in the biopharmaceutical sector.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, announced CEO John P. Butler will participate in a fireside chat at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. This virtual event will provide insights about the company’s mission and ongoing developments. A recorded version of the presentation will be available on the company’s investor website starting March 9. Akebia, founded in 2007 and based in Cambridge, Massachusetts, aims to improve the lives of those affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) reported its Q4 and full-year 2020 financial results, showing total revenue of $56.7 million for Q4, a decrease from $69.6 million in Q4 2019; full-year revenue was $295.3 million, down from $335.0 million. The decline was attributed to lower collaboration revenue of $22.1 million for Q4. Akebia announced a $60 million royalty monetization transaction with HCR and aims to submit a New Drug Application for vadadustat by mid-second quarter 2021. The company's cash position was $268.7 million at year-end, expected to support operations beyond the anticipated U.S. launch of vadadustat.
Akebia Therapeutics has appointed LeAnne M. Zumwalt to its Board of Directors, effective February 16, 2021. Zumwalt brings over 20 years of leadership experience from DaVita Inc., a major provider in the dialysis sector. Her expertise in the U.S. dialysis market is expected to aid Akebia as it prepares for the potential launch of vadadustat, a drug aimed at improving kidney patient care. The company also announced that Maxine Gowen, Ph.D., will resign from the Board on June 6, 2021.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced plans to release its financial results for Q4 and full-year 2020 on February 25, 2021, prior to market opening. A conference call is scheduled at 9:00 a.m. ET the same day to discuss these results and business highlights. Investors can access the call by phone or via the company’s website. A replay will be available shortly after the call until March 3, 2021. The firm is dedicated to improving the lives of individuals with kidney disease and was founded in 2007, headquartered in Cambridge, Massachusetts.
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