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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 the publication of FO2CUS trial results in the American Journal of Kidney Disease, evaluating Vafseo® (vadadustat) for anemia treatment in hemodialysis patients. The study compared three-times-weekly oral vadadustat dosing to long-acting ESA in 456 patients. Vafseo®, approved by FDA in March 2024 for anemia treatment in chronic kidney disease patients on dialysis, is scheduled for U.S. launch in January 2025. The study examined 600mg and 900mg vadadustat doses versus Mircera®, measuring hemoglobin changes at weeks 20-26 and 46-52.
Akebia Therapeutics (Nasdaq: AKBA) has announced its participation in the upcoming Jefferies London Healthcare Conference. CEO John Butler will deliver a presentation on Thursday, November 21 at 1:00 PM GMT. The conference is scheduled for November 19-21, 2024, in London. Interested parties can access the presentation webcast through the 'Investors' section of Akebia's website at ir.akebia.com, where it will remain available for 30 days after the event. Akebia Therapeutics focuses on improving the lives of people affected by kidney disease.
Akebia Therapeutics reported its Q3 2024 financial results and recent business highlights. Key points include the commercial launch of Vafseo® (vadadustat) expected in January 2025. Approximately 60% of U.S. dialysis patients are now covered under contracts for Vafseo. The drug has been granted TDAPA reimbursement and a Level II Healthcare Common Procedure Coding System code. Akebia also partnered with U.S. Renal Care for a trial to evaluate Vafseo's outcomes in dialysis patients.
Financially, Akebia reported total revenues of $37.4 million, down from $42.0 million in Q3 2023. Net product revenues for Auryxia were $35.6 million, down from $40.1 million. The cost of goods sold decreased to $14.2 million from $18.0 million. R&D expenses fell to $8.5 million from $13.3 million, while SG&A expenses rose to $26.5 million from $22.7 million. Akebia's net loss increased to $20.0 million from $14.5 million. The company had $34.0 million in cash and cash equivalents as of September 30, 2024.
Akebia Therapeutics (Nasdaq: AKBA) has granted stock options to three newly-hired employees as employment inducements. The options allow purchase of 20,000 shares of common stock at $1.66 per share, matching the closing price on October 31, 2024. These options vest over four years, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. The options have a 10-year term and comply with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, before market open. The company will host a conference call at 8:00 a.m. EST on the same day to discuss financial results and recent business highlights. Investors can access the call through a registration link and are encouraged to dial in 15 minutes before the scheduled start time. A live webcast and archive will be available through the company's investor relations website.
Akebia Therapeutics (Nasdaq: AKBA) has signed a multi-year commercial contract with a leading kidney care provider to expand access to Vafseo® (vadadustat) for patients on dialysis. This agreement allows physicians to prescribe Vafseo to dialysis patients as clinically appropriate, with availability expected in January 2025.
The contract is with a comprehensive kidney care provider serving over 200,000 patients at thousands of U.S. dialysis centers. Vafseo, approved by the FDA in March 2024 for treating anemia due to chronic kidney disease in adults on dialysis for at least three months, received Transitional Drug Add-On Payment Adjustment reimbursement from CMS starting January 1, 2025.
Akebia's Chief Commercial Officer, Nik Grund, emphasized that expanding access to Vafseo is a priority for their commercial launch, aiming to provide a new option in anemia management for dialysis patients.
Akebia Therapeutics (Nasdaq: AKBA) announced seven poster presentations at the American Society of Nephrology Kidney Week 2024 in San Diego, CA from October 24-27. Six posters present clinical data on vadadustat, Akebia's oral HIF-PH inhibitor for anemia due to chronic kidney disease (CKD). Vadadustat was approved by the FDA in March 2024 for adults on dialysis for at least three months, with U.S. market availability expected in January 2025.
The posters cover topics including:
- Real-world evidence from postmarketing surveillance in Japan
- Framework for assessing benefits and risks of CKD anemia treatments
- Cardiovascular safety analyses from Phase 3 trials
- Safety and efficacy in ESA-naïve patients new to dialysis
- Long-term safety data
Akebia Therapeutics (Nasdaq: AKBA) announced that the Center for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement for Vafseo® (vadadustat) starting January 1, 2025. This provides two years of additional reimbursement to dialysis organizations beyond the ESRD bundled rate. Vafseo, approved by the FDA in March 2024 for treating anemia in adults with chronic kidney disease on dialysis for at least three months, is expected to be available in January 2025.
CMS has also assigned a Level II Healthcare Common Procedure Coding System (HCPCS) code to Vafseo to facilitate billing. Akebia's Chief Commercial Officer, Nicholas Grund, highlighted the importance of TDAPA in supporting innovation and new treatments in dialysis practices. The company is actively engaging with dialysis organizations for contracting and plans to interact with healthcare providers at the upcoming American Society of Nephrology conference to drive interest in Vafseo.
Akebia Therapeutics (Nasdaq: AKBA) and U.S. Renal Care (USRC) have signed a multi-year commercial supply contract for Vafseo® (vadadustat), a treatment for anemia due to chronic kidney disease in adults on dialysis. The agreement covers all USRC dialysis centers, allowing USRC physicians to prescribe Vafseo when it becomes available in January 2025.
Vafseo was approved by the FDA in March 2024 for patients who have been on dialysis for at least three months. Akebia expects to receive Transitional Drug Add-on Payment Adjustment designation for Vafseo in January 2025. This partnership is expected to provide nearly 2000 nephrologists access to prescribe Vafseo for their patients, as clinically appropriate.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has granted stock options to a newly-hired employee as an inducement for employment. The grant, made on September 30, 2024, includes options to purchase 111,600 shares of Akebia's common stock at an exercise price of $1.32 per share, equal to the closing price on the grant date.
The options are structured with a four-year vesting period, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. These options have a 10-year term and are subject to Akebia's inducement award program and a stock option agreement. The grant was made in compliance with Nasdaq Listing Rule 5635(c)(4).
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