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Overview
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company headquartered in Cambridge, Massachusetts, dedicated to transforming lives by developing innovative therapies for patients affected by kidney disease. Specializing in chronic kidney disease and anemia treatment, Akebia leverages its deep expertise in hypoxia‐inducible factor (HIF) biology to create novel oral therapeutics that address unmet medical needs in renal care.
Core Business and Product Portfolio
At its core, Akebia Therapeutics focuses on the research, development, and commercialization of therapies aimed at improving outcomes for patients with kidney disease. The company’s diversified portfolio includes:
- Auryxia (ferric citrate): A treatment approved and marketed in the United States for the control of serum phosphorus levels in dialysis-dependent patients and the treatment of iron deficiency anemia in non-dialysis patients with chronic kidney disease. This product underscores the company’s expertise in addressing mineral and iron imbalances in renal disease.
- Vafseo (vadadustat): An investigational, once-daily oral HIF prolyl hydroxylase inhibitor. Vafseo is designed to mimic the body’s natural response to hypoxia, thereby stimulating the endogenous production of erythropoietin and effectively managing anemia in chronic kidney disease patients on dialysis. Approved in select territories and under extensive phase 3 clinical evaluation, Vafseo is positioned as a potential new oral therapeutic option for anemia treatment.
- Preclinical HIF-PH Inhibitor Programs: Akebia is also advancing a pipeline of next-generation HIF inhibitors aimed at further expanding its therapeutic reach in kidney disease and related conditions.
Market Position and Strategic Collaborations
Akebia Therapeutics occupies a distinctive niche within the biopharmaceutical sector, combining innovative science with robust commercial capabilities. The company is actively engaged in multiple strategic initiatives:
- Commercial Launch Initiatives: With a strong emphasis on enabling widespread access to its therapies, particularly Vafseo, Akebia is executing comprehensive launch strategies. The company’s commercial team collaborates closely with dialysis organizations and renal care providers to secure contracting agreements and ensure market penetration.
- Regulatory Milestones: The company has achieved significant regulatory approvals in various regions. Notably, Vafseo has been approved in select markets and is under active review in others. These accomplishments demonstrate the regulatory robustness and clinical promise of its product portfolio.
- Bidirectional Collaborations: Akebia’s collaborations with key industry partners, including large dialysis organizations and research institutions, reflect its commitment to building a sustainable ecosystem in renal care. These efforts enhance the company’s ability to drive prescriber demand and improve patient outcomes through scientific exchange and clinical evidence generation.
Clinical Evidence and Research Commitment
Central to Akebia Therapeutics’ strategy is its investment in clinical research. The company has conducted extensive phase 3 clinical trials to evaluate the safety and efficacy of its lead product candidates. Data emerging from studies such as the INNO2VATE and VOICE trials have fortified the company’s scientific foundation, demonstrating the potential of its HIF-PH inhibitor to effectively manage anemia. Akebia continues to engage the nephrology community through the dissemination of clinical data at major scientific conferences and via peer-reviewed publications, thereby reinforcing its commitment to evidence-based medicine.
Operational Excellence and Financial Stability
Akebia’s business model is underpinned by operational excellence and a strong financial foundation. The company’s strategic initiatives are carefully designed to support long-term operational stability, including robust cash management and targeted expense control. By leveraging innovative financing strategies and maintaining diversified revenue streams from its approved product, the company is well-positioned to fund its ongoing clinical development and commercial launch activities without relying on speculative financial performance metrics.
Expertise, Experience, and Trustworthiness
With a team of seasoned professionals in the fields of biotechnology, clinical research, and commercial operations, Akebia Therapeutics exemplifies the principles of Experience, Expertise, Authoritativeness, and Trustworthiness (E-E-A-T). The company’s leadership has a proven track record in navigating complex regulatory landscapes, executing clinical trials, and forging strategic partnerships. This collective expertise, combined with transparent communication and rigorous adherence to clinical standards, underscores Akebia’s commitment to delivering high-quality therapeutics in the kidney disease space.
Industry Impact and Future Endeavors
Although Akebia remains focused on its current portfolio, its impact on the biopharmaceutical landscape is significant. By providing innovative treatment options for chronic kidney disease and anemia, the company not only addresses immediate patient needs but also paves the way for future advancements in renal therapeutics. The integration of cutting-edge research with practical, market-oriented strategies has established Akebia as a trusted entity among healthcare providers, regulatory authorities, and patients alike.
Conclusion
Akebia Therapeutics is redefining the management of kidney disease through its innovative approach to anemia treatment and its strategic focus on HIF biology. Its comprehensive portfolio, deep industry expertise, and commitment to clinical excellence make it a key player in the evolution of renal care. By continuously investing in robust scientific research and fostering strategic collaborations, Akebia is setting new benchmarks in the development and commercialization of effective, patient-centric therapies.
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).
Akebia Therapeutics (Nasdaq: AKBA) and U.S. Renal Care (USRC) have announced the initiation of the VOICE trial for Vafseo® (vadadustat) in dialysis patients. The study aims to assess mortality and hospitalization outcomes compared to standard care. Key points:
- Approximately 2,200 patients will be enrolled
- Randomized to Vafseo 300 mg tablets (3x/week) or standard erythropoiesis-stimulating agents
- Primary endpoint: all-cause mortality (non-inferiority)
- Secondary endpoint: all-cause hospitalization (10% reduction, superiority)
- Trial duration: ~18 months after last patient randomization
The collaboration seeks to build real-world evidence on Vafseo's potential benefits and risks in treating anemia due to chronic kidney disease, with enrollment expected to begin in 2024.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has granted stock options to a newly-hired employee. The grant, made on August 30, 2024, includes options to purchase 4,000 shares of Akebia's common stock at an exercise price of $1.55 per share, matching the closing price on the grant date. These options were awarded as an inducement for employment and comply with Nasdaq Listing Rule 5635(c)(4).
The stock options have a four-year vesting schedule, 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 are subject to Akebia's inducement award program and a stock option agreement.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has announced its participation in two upcoming investor conferences in September 2024. The company's executives will attend the Wells Fargo Healthcare Conference in Boston from September 4-6 and the H.C. Wainwright 26th Annual Global Investment Conference in New York from September 9-11.
CEO John Butler will present at both events:
- Wells Fargo Healthcare Conference: Friday, September 6 at 9:30 a.m. EST
- H.C. Wainwright Global Investment Conference: Monday, September 9 at 10:30 a.m. EST (fireside chat)
Webcasts of both presentations will be available through Akebia's investor relations website for approximately 90 days following the conferences.
Akebia Therapeutics reported its Q2 2024 financial results, revealing a net loss of $8.6M, an improvement from $11.2M in the same quarter last year. Total revenues dropped to $43.6M from $56.4M, mainly due to a decrease in license, collaboration, and other revenues. Net product revenues stood at $41.2M, a slight decline from $42.2M in Q2 2023. Research & Development expenses significantly decreased to $7.6M from $20.2M due to the completion of certain clinical trials. The company set the WAC for its recently FDA-approved Vafseo® at $1,278 for a 30-day supply, with sales expected to begin in January 2025. Akebia expects its existing cash resources and operations to fund its activities for at least two years.
Akebia Therapeutics (Nasdaq: AKBA) has announced plans to release its financial results for the second quarter of 2024 on Thursday, August 8, 2024, before the financial markets open. The company will host a conference call at 8:00 a.m. ET on the same day to discuss the results and recent business highlights.
Investors and interested parties can access the call by dialing (800) 715-9871 (USA & Canada - Toll-Free) and entering Conference ID: 4155557. Additionally, a live webcast of the conference call will be available through the Investors section of Akebia's website at https://ir.akebia.com/. An online archive of the webcast will also be accessible via the same section of the company's website.
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