AKBA

Akebia Therapeutics to Report Second Quarter Financial Results by August 25, 2023

Retrieved on: 
Thursday, August 17, 2023

CAMBRIDGE, Mass., Aug. 17, 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 second quarter ended June 30, 2023 by Friday, August 25, 2023 prior to the open of the financial markets. Akebia will schedule a conference call in parallel with reporting its financial results.

Key Points: 
  • CAMBRIDGE, Mass., Aug. 17, 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 second quarter ended June 30, 2023 by Friday, August 25, 2023 prior to the open of the financial markets.
  • Akebia will schedule a conference call in parallel with reporting its financial results.
  • On August 10, 2023, Akebia filed with the SEC a Form 12b-25 Notification of Late Filing regarding its Quarterly Report on Form 10Q (the Form 10Q) for the quarter ended June 30, 2023.
  • Akebia plans to file the Form 10-Q by August 25, 2023, and expects to regain compliance with the Nasdaq listing requirements upon filing.

Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients

Retrieved on: 
Thursday, June 29, 2023

Auryxia is approved for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

Key Points: 
  • Auryxia is approved for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
  • IMPACT, sponsored by U.S. Renal Care Kidney Research in collaboration with Akebia, was a randomized, open-label, active-controlled, multicenter study in adult patients with CKD receiving either in-center hemodialysis or home dialysis.
  • "Results from the IMPACT study provide valuable insights into the potential impact of Auryxia in adult patients with hyperphosphatemia on dialysis.
  • Dr. Block plans to present the full study results at an upcoming scientific meeting.

Akebia Therapeutics Announces New Chief Financial Officer

Retrieved on: 
Tuesday, June 13, 2023

CAMBRIDGE, Mass., June 13, 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 Ellen Snow is joining Akebia as its new Senior Vice President, Chief Financial Officer and Treasurer, beginning on July 17, 2023.

Key Points: 
  • CAMBRIDGE, Mass., June 13, 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 Ellen Snow is joining Akebia as its new Senior Vice President, Chief Financial Officer and Treasurer, beginning on July 17, 2023.
  • Snow will join Akebia from Pear Therapeutics, Inc., where she has served as Chief Accounting Officer since 2021.
  • Snow will succeed David A. Spellman, who served as Akebia's Senior Vice President, Chief Financial Officer and Treasurer since 2020.
  • Snow served as the Chief Accounting Officer of AlerisLife Inc., a senior living and lifestyle services company, from 2019 to 2021.

Akebia Therapeutics to Present at Jefferies Healthcare Conference

Retrieved on: 
Friday, June 2, 2023

CAMBRIDGE, Mass., June 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 that John Butler, Chief Executive Officer, will present at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:30 a.m.

Key Points: 
  • CAMBRIDGE, Mass., June 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 that John Butler, Chief Executive Officer, will present at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:30 a.m.
  • ET.
  • In his presentation, Mr. Butler will discuss recent regulatory updates regarding vadadustat, Akebia's oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease for dialysis dependent patients, and the potential global commercial opportunity for Vafseo® (vadadustat).
  • The Jefferies Healthcare Conference will take place June 7-9, 2023, in New York.

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

Retrieved on: 
Tuesday, May 30, 2023

The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).

Key Points: 
  • The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).
  • Accordingly, Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date.
  • The OND's letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis dependent patients in the U.S. without suggesting the need to generate additional clinical data.
  • We appreciate the FDA's engagement with us throughout the appeal process," said John P. Butler, Chief Executive Officer of Akebia.

Akebia Therapeutics Enters into License Agreement with Medice Arzneimittel Pütter GmbH&Co.KG for the Commercialization of Vafseo® for the Treatment of Anemia associated with CKD in Europe and Australia

Retrieved on: 
Thursday, May 25, 2023

The exclusive license agreement grants Medice the rights to market and sell Vafseo in the European Economic Area in addition to the United Kingdom, Switzerland and Australia.

Key Points: 
  • The exclusive license agreement grants Medice the rights to market and sell Vafseo in the European Economic Area in addition to the United Kingdom, Switzerland and Australia.
  • Anemia associated with CKD, common in patients on dialysis, is a debilitating condition which may be associated with many adverse clinical outcomes.
  • Throughout Europe, we estimate that more than 325,000 dialysis patients are currently treated for anemia associated with CKD.
  • Vafseo is currently approved in Europe and the United Kingdom for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis.

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

Retrieved on: 
Monday, May 1, 2023

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.

Key Points: 
  • Akebia will host a conference call on Monday, May 8 at 8:30 a.m.
  • ET to discuss its financial results and recent business highlights.
  • To access the call by phone, please click on this Registration Link and you will be provided with dial in details.
  • A live webcast of the conference call will be available via the Investors section of Akebia's website at: https://ir.akebia.com/ .

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

Retrieved on: 
Friday, April 14, 2023

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.

Key Points: 
  • 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.
  • A letter to stockholders to discuss the reverse stock split proposal will be available via the Investors section of Akebia's website at: https://ir.akebia.com/ .
  • Stockholders are invited to register for the webcast and to submit questions in advance for Akebia leadership to address during the Stockholder Information Session.
  • To submit a question, stockholders should email [email protected] by Wednesday, April 19 and include the subject line: Question for Stockholder Information Session.

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

Retrieved on: 
Friday, April 7, 2023

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.

Key Points: 
  • 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 Files Revised Definitive Proxy Statement for Special Stockholder Meeting

Retrieved on: 
Friday, March 24, 2023

The Special Meeting is being held to vote on several matters including amendments to Akebia's charter to:

Key Points: 
  • The Special Meeting is being held to vote on several matters including amendments to Akebia's charter to:
    The revised proxy statement and proxy card replace the proxy statement and proxy card previously provided on or about March 1, 2023.
  • The prior proxy card may not be used to vote at the Special Meeting and will be disregarded.
  • On March 17, 2023, Akebia filed with the SEC revised proxy materials, including a revised proxy card.
  • The revised proxy statement and revised proxy card are available at www.proxyvote.com .