Akebia Therapeutics

Akebia Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of therapeutics for patients with kidney diseases. The firm is also involved in the development and commercialization of drugs for the treatment of renal and metabolic disorders. Its products include Auryxia and Vadadustat. The company was founded by Joseph H. Gardner, John M. Rice, Michael E. Pape, Josh P. Fairbank, and Robert A. Shalwitz on February 27, 2007 and is headquartered in Cambridge, MA.

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Akebia Therapeutics posts robust Q4 results, eyes expansion opportunities

Akebia Therapeutics showcased a strong performance in Q4 2022, highlighting revenue growth, regulatory progress, and strategic initiatives. The company faces challenges in regulatory processes and funding but is well-positioned to capitalize on opportunities for growth and innovation.

Akebia Therapeutics excels in Q1 2023, faces regulatory challenges

Akebia Therapeutics demonstrated strong performance in Q1 2023 with key achievements in product approvals and clinical study results, while also addressing revenue challenges and cost management.
The company faces challenges related to regulatory compliance and revenue decline but has opportunities to explore new therapeutic applications and strategic partnerships for growth.
Overall, Akebia's proactive approach to addressing challenges and pursuing opportunities positions it well for future success in the competitive biopharmaceutical market.

Akebia Therapeutics advances vadadustat globally, eyes U.S. launch in 2024

Akebia Therapeutics showcased operational progress and financial stability during the Q2 earnings call, emphasizing vadadustat's global potential.
While facing regulatory challenges and competitive pressures, the company's strategic partnerships and leadership confidence signal growth opportunities.
Analysts' inquiries highlighted areas for improvement, suggesting a need for clearer communication and strategic clarity in key operational areas.
Overall, Akebia remains focused on advancing vadadustat towards potential U.S. approval, positioning for future growth and market success.

Akebia Therapeutics reports strong Q3 earnings and readies for vadadustat launch

Akebia Therapeutics is poised for the potential launch of vadadustat with strong financial performance and a well-prepared commercial infrastructure.
The company faces challenges in pricing strategies and market competition but has opportunities to capture a significant share of the anemia treatment market.
Overall, Akebia Therapeutics remains focused on delivering value to patients and shareholders through vadadustat's potential success in the U.S. market.

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Akebia to Host Conference Call CAMBRIDGE, Mass. , March 2, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the fourth quarter and full-year ended December 30, 2022 on Thursday, March 9 prior to the open of financial markets.

Akebia Therapeutics to Report Fourth Quarter and Full-Year 2022 Financial Results and Discuss Recent Business Highlights

CAMBRIDGE, Mass. , Feb. 23, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (NASDAQ: AKBA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo™ (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Akebia Receives Positive CHMP Opinion in Europe for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

CAMBRIDGE, Mass. , Feb. 21, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for vadadustat received in March 2022.

Akebia Therapeutics Received Interim Response from the FDA to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease

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GSK announces the FDA approval of daprodustat for the treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis for at least four months.

GSK's Daprodustat Drug for Anemia Due to CKD Gets FDA Nod

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CAMBRIDGE, Mass. , Dec. 22, 2022 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received an interim response from the U.S. Food and Drug Administration (FDA) to its Formal Dispute Resolution Request regarding the Complete Response Letter received in March 2022 for vadadustat, which had been submitted to the FDA as a treatment for anemia due to chronic kidney disease in adult patients.

Akebia Therapeutics Received Interim Response to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease from the FDA

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CAMBRIDGE, Mass. , Nov. 22, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company will participate in the Piper Sandler 34th Annual Healthcare Conference, which takes place November 29-December 1, 2022 in New York City, New York.

Akebia Therapeutics to Participate in the Piper Sandler 34th Annual Healthcare Conference

Akebia Therapeutics (AKBA) delivered earnings and revenue surprises of -86.67% and 3.80%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Akebia Therapeutics (AKBA) Reports Q3 Loss, Tops Revenue Estimates

Akebia Therapeutics, Inc. (NASDAQ:AKBA ) Q3 2022 Results Conference Call November 3, 2022 4:30 PM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications John Butler - CEO, President and Director David Spellman - Senior VP, CFO and Treasurer Conference Call Participants Allison Bratzel - Piper Sandler Thomas Yip - H.C. Wainwright Operator Good day and thank you for standing by.

Akebia Therapeutics, Inc. (AKBA) Q3 2022 Earnings Call Transcript

Akebia to host conference call on November 3 at 4:30 p.m. ET   Filed Formal Dispute Resolution Request related to the CRL for vadadustat Reported Auryxia® (ferric citrate) quarterly net product revenue of $42.2, an increase of 14.9% over Q3 2021 Affirmed 2022 Auryxia net product revenue guidance of $170 - $175M Managed operating expenses in support of three strategic pillars CAMBRIDGE, Mass.

Akebia Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights

Akebia to Host Conference Call to Provide Business Update CAMBRIDGE, Mass. , Oct. 27, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the third quarter ended September 30, 2022 on Thursday, November 3, 2022 following the close of financial markets.

Akebia Therapeutics to Report Third Quarter Financial Results and Highlight Recent Company Milestones

CAMBRIDGE, Mass. , Oct. 21, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the American Society of Nephrology Kidney Week 2022 (ASN Kidney Week 2022), which will take place in Orlando, November 3-6, 2022.

Akebia Therapeutics Announces Poster Presentation at ASN Kidney Week 2022

CAMBRIDGE, Mass. , Sept. 1, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will present virtually at the H.C.

Akebia Therapeutics to Present Virtually at the H.C. Wainwright 24th Annual Global Investment Conference

Akebia Therapeutics Inc. (NASDAQ:AKBA ) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications John Butler - CEO, President and Director Steve Burke - Senior VP of Research and Development and Chief Medical Officer David Spellman - Senior VP, CFO and Treasurer Conference Call Participants Allison Bratzel - Piper Sandler Operator Hello, and welcome to the Akebia Second Quarter 2022 Financial Results. [Operator Instructions] Please note this event is being recorded.

Akebia Therapeutics Inc. (AKBA) CEO John Butler on Q2 2022 Results - Earnings Call Transcript

Akebia Therapeutics (AKBA) delivered earnings and revenue surprises of 174.19% and 158.19%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Akebia Therapeutics (AKBA) Surpasses Q2 Earnings and Revenue Estimates

Akebia to host conference call on August 4 at 4:30 p.m. ET Reported net Auryxia® (ferric citrate) product revenue of $43.7M, a 32.4% increase over Q2 2021 Increased 2022 net Auryxia product revenue guidance to $170 - $175M Regained full rights to vadadustat in the U.S., Europe and other markets Delivered a decrease in operating expenses supporting its three strategic pillars Shared initial findings from investigator-sponsored study evaluating vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in patients with COVID-19 and hypoxemia CAMBRIDGE, Mass.

Akebia Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights

CAMBRIDGE, Mass. , Aug. 4, 2022 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced initial findings from an investigator-sponsored study evaluating vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the prevention and treatment of ARDS in clinical trial subjects with COVID-19 and hypoxemia (O2 saturation ≤94%).

Akebia Therapeutics Announces Initial Findings from Investigator-Sponsored Clinical Study Evaluating Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Subjects with COVID-19 and Hypoxemia (VSTAT)

Akebia to Host Conference Call to Provide Business Update CAMBRIDGE, Mass. , July 26, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2022 on Thursday, August 4, 2022 following the close of financial markets.

Akebia Therapeutics to Report Second Quarter Financial Results

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News for Akebia Therapeutics Stock (AKBA)