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 (Nasdaq: AKBA) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO John Butler will deliver a presentation on Thursday, January 16, 2024, at 7:30 AM PST, which will include updates on the Vafseo® (vadadustat) U.S. launch and other business matters. The conference is scheduled for January 13-16, 2025, in San Francisco. Interested parties can access the presentation webcast through the 'Investors' section of Akebia's website after the conference.
Akebia Therapeutics (Nasdaq: AKBA) has granted stock options to nine newly-hired employees on November 29, 2024. The inducement grants total 121,000 shares of common stock with an exercise price of $2.06 per share, matching the closing price on the grant date. The options follow a four-year vesting schedule with 25% vesting after the first year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. These 10-year term options were granted under Nasdaq Listing Rule 5635(c)(4) as part of Akebia's inducement award program.
Akebia Therapeutics (Nasdaq: AKBA) announced that U.S. Renal Care has enrolled the first patients in the VOICE collaborative trial for Vafseo (vadadustat). The study will evaluate Vafseo's safety and efficacy when administered three times weekly to dialysis patients, comparing it to standard-of-care treatments. The trial aims to enroll approximately 2,200 patients and will assess non-inferiority for all-cause mortality as primary endpoint and superiority in reducing all-cause hospitalization as secondary endpoint. Vafseo, approved by the FDA in March 2024 for anemia in CKD patients on dialysis, is expected to launch in January 2025.
Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the 36th Annual Piper Sandler Healthcare Conference. CEO John Butler will lead a Fireside Discussion on December 3rd at 10:30 AM EST. The conference is scheduled for December 3-5, 2024 in New York. A webcast of the presentation will be available on Akebia's investor relations website for six months following the event. Akebia focuses on developing treatments for people affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced the publication of FO2CUS trial results in the American Journal of Kidney Disease, evaluating Vafseo® (vadadustat) for anemia treatment in hemodialysis patients. The study compared three-times-weekly oral vadadustat dosing to long-acting ESA in 456 patients. Vafseo®, approved by FDA in March 2024 for anemia treatment in chronic kidney disease patients on dialysis, is scheduled for U.S. launch in January 2025. The study examined 600mg and 900mg vadadustat doses versus Mircera®, measuring hemoglobin changes at weeks 20-26 and 46-52.
Akebia Therapeutics (Nasdaq: AKBA) has announced its participation in the upcoming Jefferies London Healthcare Conference. CEO John Butler will deliver a presentation on Thursday, November 21 at 1:00 PM GMT. The conference is scheduled for November 19-21, 2024, in London. Interested parties can access the presentation webcast through the 'Investors' section of Akebia's website at ir.akebia.com, where it will remain available for 30 days after the event. Akebia Therapeutics focuses on improving the lives of people affected by kidney disease.
Akebia Therapeutics reported its Q3 2024 financial results and recent business highlights. Key points include the commercial launch of Vafseo® (vadadustat) expected in January 2025. Approximately 60% of U.S. dialysis patients are now covered under contracts for Vafseo. The drug has been granted TDAPA reimbursement and a Level II Healthcare Common Procedure Coding System code. Akebia also partnered with U.S. Renal Care for a trial to evaluate Vafseo's outcomes in dialysis patients.
Financially, Akebia reported total revenues of $37.4 million, down from $42.0 million in Q3 2023. Net product revenues for Auryxia were $35.6 million, down from $40.1 million. The cost of goods sold decreased to $14.2 million from $18.0 million. R&D expenses fell to $8.5 million from $13.3 million, while SG&A expenses rose to $26.5 million from $22.7 million. Akebia's net loss increased to $20.0 million from $14.5 million. The company had $34.0 million in cash and cash equivalents as of September 30, 2024.
Akebia Therapeutics (Nasdaq: AKBA) has granted stock options to three newly-hired employees as employment inducements. The options allow purchase of 20,000 shares of common stock at $1.66 per share, matching the closing price on October 31, 2024. These options vest over four years, 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 comply with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, before market open. The company will host a conference call at 8:00 a.m. EST on the same day to discuss financial results and recent business highlights. Investors can access the call through a registration link and are encouraged to dial in 15 minutes before the scheduled start time. A live webcast and archive will be available through the company's investor relations website.
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.