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. (AKBA) is a biopharmaceutical leader developing innovative therapies for kidney disease, including FDA-approved Auryxia® and investigational oral HIF inhibitor Vafseo™. This page provides authorized updates on clinical developments, regulatory milestones, and strategic initiatives shaping renal care.
Access Akebia's official press releases covering phase 3 trial results, regulatory submissions, and commercial partnerships with dialysis providers. Investors will find timely updates on financial performance, including earnings calls and SEC filings related to anemia treatment innovations.
Our curated news collection helps stakeholders track progress in HIF biology applications and chronic kidney disease management. Bookmark this page for verified updates on product approvals, research collaborations, and market expansion strategies directly from Akebia Therapeutics.
Akebia Therapeutics (AKBA) reported a 36% increase in net Auryxia revenue, totaling $41.4 million in Q1 2022. Total revenue reached $61.7 million, up from $52.3 million a year earlier. The company provided 2022 revenue guidance for Auryxia of $165 million to $170 million. Despite a Complete Response Letter from the FDA regarding vadadustat, Akebia aims to focus on Auryxia's commercial success and explore earlier-stage assets. The cash position stands at $174.6 million.
Akebia Therapeutics (Nasdaq: AKBA) plans to release its first-quarter financial results for 2022 on May 9, 2022, after market close. The company will hold a conference call at 4:30 p.m. ET to discuss these results and provide a business update. Participants can join the call via phone or listen live on Akebia's website. A replay will be available shortly after the call concludes, lasting until May 15, 2022. Akebia focuses on developing therapeutics for individuals affected by kidney disease.
On April 6, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the National Kidney Foundation Spring Clinical Meetings 2022 in Boston, scheduled for April 6-10, 2022. The company will present three significant posters focusing on real-world healthcare costs, adherence to phosphate binders, and thrombotic events in dialysis-dependent patients. Notably, Vadadustat, an investigational drug for chronic kidney disease anemia, received a complete response letter from the FDA on March 29, 2022, while still under review by the European Medicines Agency.
On April 4, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to nine newly-hired employees, totaling 53,000 shares. Each option has an exercise price of $0.72, matching the closing stock price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on continued employment. The grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to strengthen employee retention and incentivize performance.
Akebia Therapeutics (Nasdaq: AKBA) announced that the FDA has issued a complete response letter (CRL) for its New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD). The FDA cited safety concerns, including a failure to demonstrate non-inferiority in major adverse cardiovascular events in non-dialysis patients, and risks of thromboembolic events and liver injury. Akebia plans to discuss next steps with partners and the FDA. Vadadustat remains under review in Europe and is approved in Japan for CKD-related anemia.
Akebia Therapeutics (Nasdaq: AKBA) granted stock options for 97,000 shares to 12 newly-hired employees on February 28, 2022. The exercise price is set at $2.16 per share, matching the stock's closing price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly, contingent on the employees' continued service. This grant adheres to Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent joining the company focused on kidney disease therapeutics.
Akebia Therapeutics (Nasdaq: AKBA) reported its financial results for Q4 and FY 2021, highlighting a total revenue of $59.6 million for Q4, up from $56.7 million in Q4 2020, and $213.6 million for 2021, down from $295.3 million in 2020. The net product revenue for Auryxia was $142.2 million, a 10% increase year-over-year. Akebia aims for a significant catalyst with the upcoming PDUFA date of March 29, 2022, for its drug vadadustat, which may transform treatment options for anemia due to CKD if approved.
On February 22, 2022, Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced an amended license agreement with Vifor Pharma to enable the sale of vadadustat, an investigational treatment for anemia due to chronic kidney disease (CKD). This amendment expands Vifor's access to U.S. dialysis patients, anticipated to support a U.S. launch following vadadustat's FDA PDUFA date of March 29, 2022. Vifor will invest $20 million equity and provide $40 million for working capital. Akebia will retain 66% of the profits from sales, sharing others with Otsuka in the non-dialysis market.
Akebia Therapeutics (Nasdaq: AKBA) announced plans to release its financial results for Q4 and full-year 2021 on March 1, 2022. The company will not host a conference call prior to the March 29, 2022 PDUFA date for vadadustat, an investigational drug under FDA review for treating anemia due to chronic kidney disease. Vadadustat is already approved in Japan for similar indications. The company aims to improve the lives of those affected by kidney disease.
On February 1, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 17 new employees, totaling 129,000 shares. The exercise price of these options is $1.99 per share, which corresponds with the closing stock price on the grant date, January 31, 2022. Options will vest over four years, beginning with 25% after one year. This move aims to incentivize the new hires as part of Akebia's ongoing strategy to enhance its workforce and improve outcomes in kidney disease treatment.
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