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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) announced on October 2, 2020 that it granted stock options to 11 new employees as an inducement for joining the company. The options amount to 84,000 shares with an exercise price of $2.51 per share, coinciding with the stock's closing price on the grant date. The options vest over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on the employee’s service. This move is in compliance with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announced its participation in several virtual investor conferences throughout September 2020. Key appearances include John P. Butler (CEO) at Citi's 15th Annual BioPharma Conference on September 9, and at the Morgan Stanley Global Healthcare Conference on September 15. Michel Dahan (COO) and David Spellman (CFO) will join a fireside chat at H.C. Wainwright's Global Investment Conference on September 14. Akebia aims to enhance the lives of those affected by kidney disease, presenting insights into its business strategy during these engagements.
Akebia Therapeutics (Nasdaq: AKBA) announced top-line results from the PRO2TECT Phase 3 study, which evaluated the efficacy and safety of vadadustat for treating anemia due to chronic kidney disease (CKD) in non-dialysis patients. While vadadustat demonstrated non-inferiority in hemoglobin levels compared to darbepoetin alfa, it did not meet the primary safety endpoint concerning major adverse cardiovascular events (MACE), raising concerns about its approval path. The company plans to submit a New Drug Application to the FDA in 2021 and continue collaboration with Otsuka for European approval.
On September 2, 2020, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to 10 new employees. The options, totaling 54,000 shares, were granted as inducements for employment and have an exercise price of $10.41 per share, equal to the stock's closing price on the grant date. The stock options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly. This action complies with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announces the commercial availability of VAFSEO (vadadustat) in Japan for treating anemia due to chronic kidney disease (CKD). Approved by the Ministry of Health, Labour and Welfare in June 2020, VAFSEO is now listed in the Japan National Health Insurance drug price listing. With an estimated 13 million affected by advanced CKD in Japan, this oral treatment aims to set a new standard of care. Akebia stands to gain up to $190 million in milestone payments from Mitsubishi Tanabe Pharma Corporation and will receive royalties of up to 20% on sales.
Akebia Therapeutics reported a net loss of $175.8M for Q2 2020, up from $58.2M in Q2 2019, primarily due to a $115.5M non-cash impairment charge on Auryxia. Total revenue decreased to $90.1M from $100.8M year-over-year, driven by lower collaboration revenue. However, net product revenue from Auryxia rose by 5.5% to $30.7M. The company announced that cash reserves as of June 30, 2020, amounted to $295.3M, bolstered by $142.4M from a recent stock offering. Akebia is on track to report top-line data from its Phase 3 PRO2TECT study in September.
Akebia Therapeutics (Nasdaq: AKBA) announced on August 4, 2020, the granting of stock options to four new employees totaling 23,500 shares. The options were granted on July 31, 2020, as part of the company’s Inducement Award Program, complying with Nasdaq Listing Rule 5635(c)(4). Each option has an exercise price of $11.17 per share, matching the stock's closing price on the grant date. Vesting occurs over four years, with 25% vesting after one year and the remaining shares vesting quarterly, subject to continued employment.
Akebia Therapeutics (Nasdaq: AKBA) announced it will report its second quarter financial results on August 10, 2020. The company will not hold a traditional business update call but plans a conference call in September to share top-line results from its PRO2TECT Phase 3 cardiovascular outcomes studies. These studies involved 3,513 patients and investigated the efficacy of vadadustat for treating anemia due to chronic kidney disease (CKD). The PRO2TECT database has been locked, marking a key milestone in the development of vadadustat.
Akebia Therapeutics (Nasdaq: AKBA) announced a new investigator-sponsored study to evaluate vadadustat as a potential therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. Conducted by UTHealth in Houston, the randomized, placebo-controlled trial aims to enroll up to 300 patients hospitalized for hypoxemia due to COVID-19. The dosing will start within 24 hours of admission and continue for up to 14 days. Vadadustat is also in Phase 3 trials for treating anemia due to chronic kidney disease and is currently approved for that use in Japan.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced on July 2, 2020, the grant of stock options to six newly-hired employees totaling 320,000 shares, including 280,000 shares for David Spellman, the new CFO. These options were granted as inducements for employment and comply with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $13.58 per share, reflecting the stock's closing price on the grant date, and will vest over four years.
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