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) announced an update regarding its drug vadadustat aimed at treating anemia due to chronic kidney disease. The FDA provided a second interim response to Akebia's Formal Dispute Resolution Request linked to the Complete Response Letter previously received in March 2022. Due to staffing constraints, the appeal's oversight has shifted to Dr. Peter Stein, Director at the Office of New Drugs. Akebia anticipates a decision within thirty days post Dr. Stein’s consultations with nephrology and cardiology experts.
On February 1, 2023, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to three newly-hired employees. A total of 18,000 shares were awarded as inducements for joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.63 per share, matching Akebia's closing stock price on the grant date. The options will vest over four years, with 25% vesting on the first anniversary and the rest vesting quarterly, contingent upon continued employment. These options have a 10-year term, governed by Akebia's inducement award program and related agreements.
Akebia Therapeutics (Nasdaq: AKBA) announced an interim response from the FDA regarding its Formal Dispute Resolution Request about vadadustat, aimed at treating anemia in chronic kidney disease. Following a meeting in November, Akebia will provide additional information to the FDA by January 2023, anticipating a response within 30 days post-submission. Vadadustat remains under review in Europe, while it is already approved in Japan for similar indications.
On December 2, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to a newly-hired employee, totaling 3,000 shares. These options have an exercise price of $0.27 per share, matching the closing stock price on the grant date of November 30, 2022. The options vest over four years, with 25% vesting after one year, while the remaining 75% vest quarterly, contingent on the employee's continued service. This action complies with Nasdaq Listing Rule 5635(c)(4), indicating Akebia’s commitment to attract talent.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced its participation in the Piper Sandler 34th Annual Healthcare Conference, scheduled for November 29 to December 1, 2022, in New York City. CEO John P. Butler will engage in a fireside chat on November 29 at 2:30 p.m. ET. A webcast of this session will be accessible for 90 days via the Investors section of Akebia's website. Founded in 2007 and headquartered in Cambridge, Massachusetts, Akebia focuses on developing therapeutics for kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) reported Q3 2022 financial results with net product revenue from Auryxia® reaching $42.2 million, a 14.9% year-over-year increase. The company affirmed its 2022 revenue guidance for Auryxia between $170 - $175 million. Akebia submitted a Formal Dispute Resolution Request to the FDA regarding the Complete Response Letter for vadadustat, anticipating clarity on regulatory approval timelines. The quarterly net loss decreased to $51.9 million, and cash resources of $144.8 million are expected to sustain operations for at least a year.
Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to five new employees, totaling 30,000 shares, on October 31, 2022. The options, priced at $0.25 per share, equal the closing price on the grant date and will vest over four years, with 25% vesting after the first year and the remainder quarterly. This inducement was made in compliance with Nasdaq Listing Rule 5635(c)(4). Akebia aims to enhance the lives of those affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced it will release its Q3 2022 financial results on November 3, 2022, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results and recent company developments. The conference call can be accessed through a registration link provided in the announcement. Akebia, based in Cambridge, Massachusetts, is focused on improving the lives of those impacted by kidney disease.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced its participation in ASN Kidney Week 2022, taking place from November 3-6 in Orlando. The company will present a poster titled "Prevalence of Hyporesponse to Erythropoiesis-Stimulating Agents Among Medicare Patients with CKD-Related Anemia" on November 3 from 10:00 a.m. to 12:00 p.m. EDT. Attendees can visit Akebia at Booth #1721 for more information. Founded in 2007 and based in Cambridge, Massachusetts, Akebia focuses on developing therapeutics for kidney disease.
On October 3, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options for 50,000 shares to four new employees, as an inducement for their employment. The options, awarded on September 30, 2022, have an exercise price of $0.32 per share, matching the closing stock price on the grant date. These options vest over four years, beginning with 25% on the first anniversary and the remaining 75% quarterly, contingent on the employees' continued service. The announcement complies with Nasdaq Listing Rule 5635(c)(4).