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.
Akebia Therapeutics announced the appointment of Ron Frieson to its Board of Directors, enhancing the company's focus on improving patient outcomes in kidney disease. Frieson, currently COO at Children's Healthcare of Atlanta, brings over 20 years of experience in healthcare and public policy. His expertise in health equity and access is viewed as crucial for Akebia's mission. CEO John P. Butler expressed confidence in Frieson's ability to drive operational improvements and address healthcare disparities, especially impacting underserved populations.
Akebia Therapeutics (Nasdaq: AKBA) announced that its collaborator, Otsuka Pharmaceutical, submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat. This investigational oral treatment targets anemia associated with chronic kidney disease (CKD) in adults. The application marks a significant milestone towards providing a new treatment option for CKD patients in Europe. Vadadustat mimics altitude effects to boost red blood cell production. If approved, Akebia plans to support its commercial launch in Europe.
Akebia Therapeutics (Nasdaq: AKBA) will release its third-quarter financial results on November 4, 2021. A conference call is scheduled for November 9, 2021, at 9:00 a.m. ET to discuss these results and highlight upcoming presentations at the American Society of Nephrology Kidney Week. The call will include discussions on the global Phase 3 data for vadadustat, which is under FDA review with a PDUFA date of March 29, 2022 for treating anemia related to chronic kidney disease.
Akebia Therapeutics is committed to improving the lives of kidney disease patients through innovative therapies. Their product, Auryxia, is FDA-approved for managing phosphorus levels in CKD patients on dialysis and treating iron deficiency anemia in those not on dialysis. However, a lawsuit against CMS seeking Medicare coverage for Auryxia was dismissed. Despite setbacks, Akebia is exploring legislative solutions for coverage restoration. The company's commitment to health equity remains strong, supported by various organizations advocating for patient access to critical treatments.
Akebia Therapeutics (Nasdaq: AKBA) announced that vadadustat efficacy and safety data will be showcased at the ASN Kidney Week 2021 from November 4-7, 2021. Vadadustat, an oral HIF-PH inhibitor, is under FDA review with a PDUFA date of March 29, 2022. The presentation includes multiple abstracts highlighting vadadustat's potential in treating anemia due to chronic kidney disease. Additionally, Akebia will present data on Auryxia, exploring its effectiveness in preventing renal failure in CKD patients.
Akebia Therapeutics (Nasdaq: AKBA) granted stock options to 17 newly-hired employees on September 30, 2021. The options, totaling 180,000 shares, have an exercise price of $2.88 per share, equal to the stock's closing price on that date. Each option vests over four years, beginning with 25% on the first anniversary of the grant, and is subject to continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent in the biopharmaceutical sector focused on kidney disease.
On September 1, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to nine new employees, totaling 89,000 shares. The options, with an exercise price of $2.94 per share, align with Nasdaq Listing Rule 5635(c)(4) and will vest over four years. 25% will vest on the first anniversary, with the remainder vesting quarterly, contingent on continued service. This strategic move is aimed at incentivizing new hires in the biopharmaceutical sector focused on kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced a series of investor conference participations. CEO John P. Butler and CFO David A. Spellman will partake in three significant conferences this September, including the Morgan Stanley Global Healthcare Conference on September 9, H.C. Wainwright Global Investment Conference on September 13, and Cantor Fitzgerald Global Healthcare Conference on September 27. These events aim to update investors about Akebia's progress in developing therapeutics for kidney disease. Live webcasts of these events will be available on the company's investor relations website.
Akebia Therapeutics (AKBA) reported a net loss of $83.0 million for Q2 2021, an improvement from a loss of $175.8 million in Q2 2020. Total revenue decreased to $52.9 million from $90.1 million year-over-year, primarily due to lower collaboration revenue, which fell to $20.0 million from $59.4 million. Net product revenue for Auryxia rose to $33.0 million, a 7.4% increase. Akebia announced FDA acceptance of the vadadustat NDA with a PDUFA date of March 29, 2022, indicating potential market opportunities in treating anemia due to chronic kidney disease.
Akebia Therapeutics granted stock options to 14 newly-hired employees, totaling 95,000 shares at an exercise price of $2.47 per share, equivalent to the stock’s closing price on the grant date, July 30, 2021. The stock options will vest over four years, with 25% vesting after the first year and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), reflecting Akebia's commitment to attracting talent in the biopharmaceutical sector focusing on kidney disease treatment.