Welcome to our dedicated page for Akebia Therapeut news (Ticker: AKBA), a resource for investors and traders seeking the latest updates and insights on Akebia Therapeut stock.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) is a biopharmaceutical company focused on therapies for people impacted by kidney disease, and its news flow reflects this specialization. Company announcements frequently highlight progress with Vafseo (vadadustat), a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for the treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis for at least three months. Updates include prescribing access among dialysis organizations, clinical trial data such as post-hoc analyses from the INNO2VATE trials, and real-world studies like VOICE and VOCAL that examine mortality, hospitalization, and dosing strategies.
News releases also cover Akebia’s rare kidney disease pipeline, including praliciguat and AKB-097. Investors can follow milestones such as the first patient dosed in a Phase 2 trial of praliciguat for biopsy-confirmed focal segmental glomerulosclerosis (FSGS), plans to evaluate praliciguat in other rare podocytopathies, and the planned Phase 2 basket study of AKB-097 across complement-mediated rare kidney diseases, including IgA nephropathy, lupus nephritis, and C3 glomerulopathy. Additional pipeline updates may involve AKB-9090, a HIF-PH inhibitor entering Phase 1 for acute kidney injury associated with cardiac surgery.
Akebia’s news stream also includes financial results, stock option inducement grants under Nasdaq Listing Rule 5635(c)(4), licensing and supply agreements such as amendments to its Vafseo license with Medice in Europe and certain other countries, and participation in healthcare and investor conferences. For investors tracking AKBA, this news page provides a centralized view of clinical, regulatory, commercial, and corporate developments that shape the company’s kidney disease franchise and pipeline trajectory.
On October 23, 2020, Akebia Therapeutics (Nasdaq: AKBA) presented clinical data from its PRO2TECT Phase 3 program at ASN Kidney Week. The program assessed the efficacy and safety of vadadustat versus darbepoetin alfa for treating anemia due to chronic kidney disease (CKD) in patients not on dialysis. Vadadustat met its primary and key secondary efficacy endpoints, achieving non-inferiority. However, it failed to meet the primary safety endpoint concerning major adverse cardiovascular events (MACE), although further analysis indicated no significant increase in cardiovascular risk for U.S. patients.
Akebia Therapeutics (Nasdaq: AKBA) presented data from its INNO2VATE Phase 3 program at ASN Kidney Week 2020, highlighting the efficacy and cardiovascular safety of vadadustat for treating anemia in adult dialysis patients. The results showed vadadustat's non-inferiority to darbepoetin alfa across key metrics, including major adverse cardiovascular events (MACE). Akebia aims to submit a New Drug Application (NDA) to the FDA in 2021 and plans to present additional trial results at ASN Kidney Week.
Akebia Therapeutics (Nasdaq: AKBA) announced it will present data from its global Phase 3 programs for vadadustat, targeting anemia due to chronic kidney disease (CKD), at the ASN Kidney Week from October 22-25, 2020. The INNO2VATE program, focusing on patients on dialysis, and the PRO2TECT program for non-dialysis patients will showcase promising results. Vadadustat met primary and key secondary efficacy endpoints in INNO2VATE, while PRO2TECT achieved primary efficacy but failed its primary safety endpoint. Akebia's abstract from PRO2TECT has been selected for a late-breaking presentation.
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.
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