Akebia Bundle
What is Akebia Therapeutics' kidney disease focus?
Akebia Therapeutics is a biopharmaceutical company dedicated to developing treatments for kidney diseases. Their primary focus is on utilizing hypoxia-inducible factor (HIF) biology to address anemia in patients with chronic kidney disease (CKD).
A significant milestone for the company was the FDA approval of Vafseo (vadadustat) tablets in March 2024. This oral medication is for adults with anemia due to CKD who are on dialysis, offering a new treatment avenue.
Founded in 2007 in Cambridge, Massachusetts, Akebia aimed to create innovative therapies for kidney disease patients. The company is now focused on the global rollout of Vafseo, following the divestiture of Auryxia. This strategic shift positions them to compete in a market often led by larger pharmaceutical firms, providing an alternative to traditional treatments. Their journey highlights a strong commitment to enhancing the lives of those affected by kidney conditions, including through products like Akebia Porter's Five Forces Analysis.
What is the Akebia Founding Story?
Akebia Therapeutics history began in 2007 in Cambridge, Massachusetts. The company was established with a clear mission to innovate in the treatment of anemia, focusing on patients with kidney disease.
The Genesis of Akebia Therapeutics
Akebia Therapeutics was founded in 2007, with key figures like John P. Butler serving as the initial President and CEO. The company's core mission was to develop novel treatments for anemia, particularly for individuals suffering from serious kidney diseases. This focus was built upon leveraging hypoxia-inducible factor (HIF) biology.
- Founded in 2007 in Cambridge, Massachusetts.
- Initial mission: discover and develop novel treatments for anemia.
- Targeted unmet medical needs in patients with serious kidney diseases.
- Leveraged hypoxia-inducible factor (HIF) biology.
The early years of Akebia Therapeutics were marked by significant venture capital funding, essential for advancing its research and development pipeline. These investments were crucial for the company's journey towards developing its innovative approach to anemia management. The company's strategy centered on creating oral treatments, a departure from the prevailing injectable therapies.
Early Funding and Strategic Focus
Akebia secured substantial venture capital funding, raising tens of millions before its Initial Public Offering (IPO). For instance, the company raised a Series A round of $28 million on June 16, 2010, followed by a Series B round of $22 million on April 26, 2011, and a Series C round of $41 million on June 4, 2013. These early rounds were supported by institutional investors including Kearny Venture Partners, Venture Investors, Genechem, Triathlon Medical Ventures, and Athenian Venture Partners. The company's commitment to developing oral HIF-PHI inhibitors represented a significant innovation in anemia treatment, differentiating it from existing injectable options.
- Series A funding: $28 million (June 16, 2010).
- Series B funding: $22 million (April 26, 2011).
- Series C funding: $41 million (June 4, 2013).
- Focus on oral HIF-PHI inhibitors as a novel treatment approach.
- Supported by investors like Kearny Venture Partners and Venture Investors.
The Akebia Therapeutics founding story highlights a strategic vision to address a critical need in patient care through scientific innovation. This early phase laid the groundwork for the company's future milestones and its evolution over time. Understanding the Akebia Therapeutics history provides insight into its commitment to advancing medical treatments.
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What Drove the Early Growth of Akebia?
Akebia Therapeutics experienced significant growth and strategic evolution early in its history. A pivotal moment was its Initial Public Offering in 2014, which provided substantial capital for its drug development efforts.
Akebia Therapeutics IPO and Early Funding
In 2014, Akebia Therapeutics successfully completed its Initial Public Offering (IPO) on the NASDAQ exchange under the ticker AKBA. This event raised approximately $100 million, a crucial financial injection that fueled the clinical development of its lead drug candidate, vadadustat.
Strategic Acquisition and Commercialization Shift
A transformative event in the Akebia history occurred in 2017 with the acquisition of Keryx Biopharmaceuticals. This strategic move expanded Akebia's operations beyond clinical-stage development by incorporating Keryx's commercial product, Auryxia, used for hyperphosphatemia and iron deficiency anemia in chronic kidney disease (CKD) patients.
Pipeline Advancement and Key Collaborations
The company consistently focused on advancing its pipeline, with vadadustat, an oral HIF-PH inhibitor, remaining a central development program. Akebia established significant collaborations, including agreements with Otsuka Pharmaceutical Co. Ltd. and Mitsubishi Tanabe Pharma Corporation, to support the global development and commercialization of vadadustat.
Financial Performance and Revenue Growth
By the end of fiscal year 2023, Akebia reported total revenues of nearly $150 million. The first quarter of 2025 saw total revenues reach $57.3 million, a substantial increase from $32.6 million in Q1 2024, largely driven by the initial sales of Vafseo and increased Auryxia sales. Auryxia net product revenues alone were $43.8 million in Q1 2025, up from $31.0 million in Q1 2024, highlighting the growing contribution of its commercial products and demonstrating the impact of its diversified Revenue Streams & Business Model of Akebia.
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What are the key Milestones in Akebia history?
Akebia Therapeutics has navigated a dynamic path marked by significant achievements and considerable hurdles in its journey. A pivotal moment arrived on March 27, 2024, with the U.S. FDA's approval of Vafseo (vadadustat) tablets for treating anemia in adult patients with chronic kidney disease (CKD) on dialysis for at least three months. This approval followed extensive clinical trials, including the INNO2VATE program, and post-marketing data from Japan, where Vafseo was first introduced in August 2020. Vafseo, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, offers a novel, once-daily alternative to injectable erythropoiesis-stimulating agents (ESAs), marking a key advancement in patient care.
| Year | Milestone |
|---|---|
| August 2020 | Vafseo launched in Japan. |
| March 27, 2024 | U.S. FDA approval of Vafseo (vadadustat) tablets for anemia due to CKD in adult dialysis patients. |
| January 2024 | Secured a $55 million loan facility from BlackRock funds. |
| October 2024 | Vafseo granted Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement by CMS, effective January 1, 2025. |
| December 2024 | U.S. Renal Care enrolled the first patients in the VOICE clinical trial of Vafseo. |
Vafseo represents a significant innovation as an oral HIF-PH inhibitor, providing a once-daily treatment option that contrasts with traditional injectable therapies for anemia associated with chronic kidney disease. This development aims to improve patient convenience and adherence.
Oral HIF-PH Inhibition
Vafseo's development as an oral, once-daily HIF-PH inhibitor offers a new therapeutic approach for anemia in CKD patients. This innovation provides a convenient alternative to existing injectable treatments.
TDAPA Reimbursement
The attainment of TDAPA reimbursement for Vafseo by CMS is a crucial step towards ensuring broad patient access. This designation is expected to facilitate wider adoption of the treatment in dialysis settings.
VOICE Clinical Trial
The initiation of the collaborative VOICE clinical trial, comparing Vafseo to the current standard of care, is designed to further strengthen the evidence base for the drug. This trial aims to assess mortality and hospitalization rates.
The company faced significant challenges, including an FDA Complete Response Letter (CRL) for vadadustat due to safety concerns, which caused a two-year delay in its U.S. approval. This period necessitated strategic adjustments, including workforce reductions and a focus on the commercial asset Auryxia to ensure operational continuity. Navigating these regulatory and financial pressures tested the company's resilience and strategic planning, underscoring the inherent risks in drug development. The company's ability to secure funding, such as the $55 million loan facility in January 2024, was vital during these critical phases, demonstrating a commitment to overcoming obstacles and advancing its pipeline. Understanding the Growth Strategy of Akebia provides further context on how the company managed these challenges.
FDA Complete Response Letter
Akebia encountered a significant setback with an FDA CRL for vadadustat, citing safety concerns. This resulted in a substantial delay to the drug's U.S. approval timeline.
Strategic Restructuring
In response to regulatory challenges, the company implemented strategic pivots, including workforce reductions of approximately half its staff. This was a necessary measure to manage resources effectively.
Financial Resilience
Securing a $55 million loan facility in January 2024 was critical for strengthening the company's financial position. This funding was essential to support operations and navigate the path to potential Vafseo approval.
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What is the Timeline of Key Events for Akebia?
The Akebia Therapeutics history is marked by significant milestones in drug development and corporate growth, from its founding in 2007 to recent regulatory approvals and strategic financial maneuvers. This journey reflects a commitment to addressing unmet needs in kidney disease treatment.
| Year | Key Event |
|---|---|
| 2007 | Akebia Therapeutics was founded in Cambridge, Massachusetts. |
| 2010 | The company secured $28 million in Series A funding. |
| 2011 | Akebia raised an additional $22 million in Series B funding. |
| 2013 | A Series C funding round brought in $41 million, and John P. Butler joined as a director, later becoming President and CEO. |
| 2014 | Akebia Therapeutics launched its Initial Public Offering (IPO) on the NASDAQ Global Market, raising approximately $100 million. |
| 2017 | The company merged with Keryx Biopharmaceuticals, integrating the commercial product Auryxia. |
| 2020 | Vafseo (vadadustat) was launched in Japan. |
| 2024 | Akebia secured a $55 million loan facility and received U.S. FDA approval for Vafseo tablets for anemia due to CKD in adult dialysis patients. |
| 2024 | CMS granted TDAPA reimbursement for Vafseo, effective January 1, 2025, and U.S. Renal Care began enrolling patients in the VOICE trial. |
| 2025 | Vafseo shipments commenced in the U.S., with projected Q1 2025 net product revenues of $10-$11 million. Auryxia market exclusivity is set to expire in March 2025. |
| Q1 2025 | Akebia reported $12.0 million in Vafseo net product revenues and $43.8 million in Auryxia net product revenues, with total revenues reaching $57.3 million and a net income of $6.1 million. |
| Second half of 2025 | The company plans to initiate the VALOR clinical trial to explore Vafseo's use in the non-dialysis CKD population. |
Vafseo Commercialization and Label Expansion
Akebia's future hinges on the successful rollout of Vafseo, aiming to establish it as a new oral standard of care for dialysis patients. The planned VALOR trial in the second half of 2025 is crucial for expanding its market reach to non-dialysis CKD patients.
Financial Stability and Growth Projections
The company anticipates its current cash and operational cash flow will sustain its operating plan for at least two years, supporting the Vafseo launch and pipeline development. Analyst projections for Akebia Therapeutics (AKBA) stock in 2025 indicate an average price target of $5.0739, suggesting potential growth.
Revenue Drivers and Strategic Partnerships
Securing contracts with dialysis organizations is a key strategy to boost Vafseo revenue, with projections of $136 million in FY25, potentially increasing to $374 million by FY28. Understanding the Target Market of Akebia is vital for this strategy.
Long-Term Vision and Patient Impact
Akebia's strategic direction aligns with its founding mission to enhance the quality of life for individuals affected by kidney conditions. The company's focus on innovative treatments aims to create lasting positive impacts on patient care.
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