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. develops and commercializes therapeutics for people impacted by kidney disease. Company news commonly covers Vafseo® (vadadustat), an oral HIF-PH inhibitor indicated for anemia due to chronic kidney disease in adults receiving dialysis, and Auryxia® (ferric citrate), a U.S.-marketed therapy for chronic kidney disease-related conditions.
Recurring updates also address product revenue, dialysis-market access, clinical data publications, and kidney disease pipeline programs, including praliciguat in focal segmental glomerulosclerosis, AKB-097 in rare kidney diseases, and AKB-9090 for cardiac surgery-associated acute kidney injury. Akebia also reports Nasdaq inducement grants, board changes, investor presentations, and quarterly financial results.
Akebia Therapeutics (Nasdaq: AKBA) reported a net product revenue of $177.1 million for 2022, a 24.5% increase from 2021. The company anticipates potential Marketing Authorization for its drug Vafseo™ (vadadustat) in Europe by May 2023 after receiving a positive opinion from the CHMP. For 2023, Akebia set a revenue guidance of $175-$180 million for Auryxia, although it remains cautious regarding the phosphate binder market recovery due to ongoing COVID-19 impacts. Significant operational improvements were made, including a restructuring of the supply chain which reduced costs.
Akebia Therapeutics (NASDAQ: AKBA) will release its financial results for the fourth quarter and full-year ended December 30, 2022, on March 9, 2023, before market opening. The company aims to improve the lives of those affected by kidney disease and plans to host a conference call at 8:30 a.m. ET on the same day to discuss its results and business updates. Interested parties can access the call via a registration link or through a live webcast on Akebia's website. The company emphasizes its commitment to innovation in kidney disease therapeutics.
Akebia Therapeutics (NASDAQ: AKBA) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the approval of Vafseo™ (vadadustat) for treating symptomatic anemia in adults with CKD on chronic dialysis. The decision from the European Commission (EC) is expected within two months and is applicable in all EU member states plus Iceland, Norway, and Liechtenstein.
The CHMP's recommendation is based on comprehensive data from over 7,500 patients, demonstrating the drug's efficacy and safety in clinical trials. The positive opinion is crucial for Akebia's goal to partner in Europe for Vafseo's commercialization.
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.