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.

Earnings data Q1 2021

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Earnings data Q1 2022

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Earnings data Q3 2023

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Earnings data Q1 2024

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Earnings data Q4 2024

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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CAMBRIDGE, Mass. , May 22, 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 it has received a formal notice from The Nasdaq Stock Market (Nasdaq) stating that Akebia has regained compliance with the $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2), and that Akebia is in compliance with all applicable listing standards.

Akebia Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

CAMBRIDGE, Mass. , May 22, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Akebia Announces UK MHRA Approval of Vafseo® (vadadustat) for the Treatment of Symptomatic Anemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

Akebia Therapeutics, Inc. (NASDAQ:AKBA ) Q1 2023 Earnings Conference Call May 8, 2023 8:30 AM ET Company Participants Mercedes Carrasco - Senior Director of Investor and Corporate Communications John Butler - Chief Executive Officer Dave Spellman - Chief Financial Officer 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) Q1 2023 Earnings Call Transcript

Akebia to host conference call on May 8 at 8:30 a.m. ET Announced vadadustat is now approved in 32 countries following European Commission marketing authorization Expects a response to Formal Dispute Resolution from FDA within next 30 days Released positive top-line results from vadadustat alternative dosing study Reports Auryxia® (ferric citrate) net product revenue of $34.8M for Q1 2023 Affirms 2023 Auryxia net product revenue guidance at $175-$180M CAMBRIDGE, Mass.

Akebia Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Akebia Therapeutics (AKBA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will Akebia Therapeutics (AKBA) Report Negative Q1 Earnings? What You Should Know

Akebia to Host Conference Call CAMBRIDGE, Mass. , May 1, 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 first quarter ended March 31, 2023 on Monday, May 8, 2023, prior to the open of financial markets.

Akebia Therapeutics to Report First Quarter Financial Results and Discuss Recent Business Highlights

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CAMBRIDGE, Mass. , April 25, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA) today announced that the European Commission (EC) has granted marketing authorisation for 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 European Commission Approval for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

CAMBRIDGE, Mass., April 14, 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 it will host a stockholder information session on Friday, April 21 at 8:00 a.m. ET to discuss its upcoming special meeting of stockholders (Special Meeting) to seek stockholder approval to, among other things, effect a reverse stock split of Akebia's outstanding common stock, which Akebia believes would allow it to regain compliance with the Nasdaq Stock Market's (Nasdaq) minimum bid price rule and avoid delisting.

Akebia Therapeutics to Host Stockholder Information Session to Discuss Rationale for Reverse Stock Split

CAMBRIDGE, Mass., April 11, 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 it adjourned, without conducting any business, the special meeting of stockholders (the "Special Meeting") on Tuesday, April 11, 2023 to allow the company to solicit from its stockholders the additional proxies necessary to obtain approval of the proposals described in the company's revised definitive proxy statement filed with the Securities and Exchange Commission on March 17, 2023.

Akebia Therapeutics Announces Adjournment of Special Meeting of Stockholders

CAMBRIDGE, Mass. , April 7, 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 it will present posters at the National Kidney Foundation (NKF) Spring Clinical Meetings 2023 (SCM23), which will take place on demand and live in Austin, Texas on April 11 – 15, 2023.

Akebia Therapeutics Announces Poster Presentations at National Kidney Foundation Spring Clinical Meetings 2023

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Data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA as a treatment for anemia due to chronic kidney disease when administered three times a week at the time of dialysis Vadadustat demonstrated a similar safety profile to long-acting ESA when used three times a week CAMBRIDGE, Mass. , April 3, 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 positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia.

Akebia Therapeutics Announces Positive Top-Line Results from Vadadustat Alternative Dosing Study

CAMBRIDGE, Mass. , March 30, 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 met with the U.S. Food and Drug Administration (FDA) Office of New Drugs (OND) deciding authority to discuss Akebia's Formal Dispute Resolution regarding the Complete Response Letter for vadadustat received in March 2022.

Akebia Therapeutics Provides Update on Regulatory Process for Vadadustat

CAMBRIDGE, Mass. , March 24, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that it has filed a revised definitive proxy statement with the Securities and Exchange Commission (SEC) in connection with a special meeting (Special Meeting) of stockholders scheduled on April 11, 2023 at 10:00 a.m.

Akebia Therapeutics Files Revised Definitive Proxy Statement for Special Stockholder Meeting

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Akebia Therapeutics, Inc. (NASDAQ:AKBA ) Q4 2022 Earnings Conference Call March 9, 2023 8:30 AM ET Company Participants Mercedes Carrasco - Investor Relations and Corporate Communications John Butler - President and Chief Executive Officer David Spellman - Senior Vice President, Chief Financial Officer Conference Call Participants Allison Bratzel - Piper Sandler Ed Arce - H.C. Wainwright & Co. Robert Hazlett - BTIG Operator Good day ladies and gentlemen.

Akebia Therapeutics, Inc. (AKBA) Q4 2022 Earnings Call Transcript

Akebia Therapeutics (AKBA) delivered earnings and revenue surprises of 71.43% and 14.14%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Akebia Therapeutics (AKBA) Reports Q4 Loss, Tops Revenue Estimates

Akebia to host conference call on March 9 at 8:30 a.m. ET Receives positive CHMP opinion for Vafseo™ (vadadustat); anticipates potential Marketing Authorization in Europe in May 2023 Reports Auryxia® (ferric citrate) net product revenue of $177.1M for 2022, an increase of approximately 24.5% over 2021 Sets 2023 Auryxia net product revenue guidance at $175-$180M CAMBRIDGE, Mass.

Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights

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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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