AKBA Akebia Therapeutics Inc.

13.08
+0.18  (+1%)
Previous Close 12.9
Open 13.03
52 Week Low 2.99
52 Week High 13.68
Market Cap $1,869,340,561
Shares 142,915,945
Float 140,343,531
Enterprise Value $1,835,616,690
Volume 1,275,772
Av. Daily Volume 1,983,576
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Upcoming Catalysts

Drug Stage Catalyst Date
Vadadustat - PRO2TECT
Non-dialysis patients with anemia related to CKD (NDD-CKD)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Vadadustat - INNO2VATE
Anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)
Phase 3
Phase 3
Phase 3 data met primary endpoints - May 5, 2020.
Vadadustat - TRILO2GY
Three-times-weekly dosing regimen for vadadustat
Phase 3
Phase 3
Phase 3 trial to be initiated in 2019.
Auryxia
Iron deficiency anemia in non-dialysis dependent CKD patients
Approved
Approved
sNDA FDA Approval announced November 7, 2017.
Auryxia
Hyperphosphatemia
Approved
Approved
Approved Sept 5, 2014.

Latest News

  1. CAMBRIDGE, Mass., July 2, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted six newly-hired employees options to purchase an aggregate of 320,000 shares of Akebia's common stock on June 30, 2020, including an option to purchase 280,000 shares granted to David Spellman, Akebia's newly-hired Senior Vice President, Chief Financial Officer. The options were granted as inducements material to each such employee's entering into employment with Akebia. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    CAMBRIDGE, Mass., July 2, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted six newly-hired employees options to purchase an aggregate of 320,000 shares of Akebia's common stock on June 30, 2020, including an option to purchase 280,000 shares granted to David Spellman, Akebia's newly-hired Senior Vice President, Chief Financial Officer. The options were granted as inducements material to each such employee's entering into employment with Akebia. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)" alt="Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)">

    The options have an exercise price of $13.58 per share, which is equal to the closing price of Akebia's common stock on the grant date. Each stock option vests over four years, with 25% of the shares vesting on the first anniversary of the grant date and the remaining 75% of shares vesting quarterly thereafter, in each case, subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of the company's Inducement Award Program and a stock option agreement covering the grant.

    About Akebia Therapeutics

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

    Akebia Therapeutics Contact

    Kristen K. Sheppard, Esq.

     

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  2. CAMBRIDGE, Mass., June 29, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD). Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia's collaboration partner in Japan for vadadustat, has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. Vadadustat will…

    CAMBRIDGE, Mass., June 29, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD). Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia's collaboration partner in Japan for vadadustat, has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO.

    AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)" alt="Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)">

    An estimated 13 million people in Japan have advanced stages of CKD. Anemia is common in patients with CKD and its prevalence increases as CKD progresses. Injectable erythropoiesis-stimulating agents (ESAs) are currently the standard of care. Vadadustat provides adult patients with a convenient, once-daily oral therapeutic for the treatment of anemia due to CKD in Japan.

    "Today's announcement represents the first regulatory approval of vadadustat and is a significant step forward for patients with anemia due to CKD in Japan," said John P. Butler, President and Chief Executive Officer of Akebia. "We believe this milestone marks the beginning of the next phase of Akebia's growth story and we are excited to support our collaboration partner, MTPC, with the expected commercialization of vadadustat in Japan later this year."

    MTPC filed a Japanese New Drug Application for vadadustat in July 2019. The approval was based on data from the vadadustat development program, including MTPC's two Phase 3 active-controlled pivotal studies, which support the efficacy and safety of vadadustat in treating both adult patients on dialysis and those not on dialysis with anemia due to CKD in Japan. 

    Akebia and MTPC entered into a collaboration agreement in 2015 providing MTPC with exclusive rights to develop and commercialize vadadustat in Japan and certain other Asian countries. The regulatory approval announced today triggers a $15 million milestone payment from MTPC to Akebia. In addition, Akebia is eligible to receive up to approximately $190 million in additional milestone payments from MTPC, based upon achievement of certain regulatory and sales milestones. MTPC is also obligated make tiered double-digit royalty payments to Akebia of up to 20% on sales of vadadustat in Japan and certain other Asian countries, subject to regulatory approval of vadadustat. 

    About Vadadustat

    Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA).

    About Akebia Therapeutics

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts.

    Forward-Looking Statements

    Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding Akebia's growth story and the commercialization of VAFSEO in Japan, including the timing thereof. The terms "believe," "expect" and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the potential direct or indirect impact of the COVID-19 pandemic on our and our partners', collaborators', vendors' and customers' businesses, operations, and the markets and communities in which we and our partners, collaborators, vendors and customers operate; manufacturing risks; risks associated with management and key personnel changes and transitional periods; market acceptance and coverage and reimbursement of VAFSEO in Japan; the risks associated with potential generic entrants; early termination of any of Akebia's collaborations; Akebia's and its collaborators' ability to satisfy their obligations under Akebia's collaboration agreements; the timing and content of decisions made by regulatory authorities; the competitive landscape; the scope, timing, and outcome of any legal, regulatory and administrative proceedings; changes in the economic and financial conditions of the businesses of Akebia and its partners; and Akebia's and its partners' ability to obtain, maintain and enforce patent and other intellectual property protection. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

    Akebia Therapeutics

    Kristen K. Sheppard, Esq.

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  3. CAMBRIDGE, Mass., June 22, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the launch of AkebiaShares, a peer-to-peer educational program series for the kidney community to virtually connect and to support one another and patients with chronic kidney disease (CKD) during the COVID-19 pandemic. Through virtual discussions and events, AkebiaShares aims to bring together kidney professionals who can share information and best practices on topics related to providing continuous care to patients.

    CAMBRIDGE, Mass., June 22, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the launch of AkebiaShares, a peer-to-peer educational program series for the kidney community to virtually connect and to support one another and patients with chronic kidney disease (CKD) during the COVID-19 pandemic. Through virtual discussions and events, AkebiaShares aims to bring together kidney professionals who can share information and best practices on topics related to providing continuous care to patients.

    AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)" alt="Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)">

    The first AkebiaShares educational session is a virtual panel discussion for kidney professionals about CKD patient care in the COVID-19 environment. The virtual panel discussion will take place on Thursday, June 25, 2020 at 7:30 p.m. ET.

    Open registration for the complimentary event is available at: https://portal.xyvid.com/akebiashares

    The discussion will be moderated by Richard J. Lund, M.D., a nephrologist at Omaha Nephrology, P.C. and Jessianna Saville, MS, RDN, CSR, LD, CLT, a renal dietitian and founder of The Kidney RD.  

    Panelists include:

    • Karen Robertson, DNP, ANP, Nurse Practitioner at Carolina Nephrology
    • German Hernandez, M.D. Nephrologist, El Paso Kidney Specialists

    The COVID-19 pandemic has presented a significant public health challenge. The panel participants will share their experiences and discuss the evolving ways kidney patient care teams engage with and support patients since COVID-19 has emerged. Specifically, the participants plan to cover mitigation strategies for reducing transmission of COVID-19 between patients and providers, telehealth best practices and interest among patients in home therapies modalities.

    "Our inaugural AkebiaShares program is especially timely as people with CKD are among those most at risk for health complications or interruptions of care during the global COVID-19 pandemic," said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia. "As a physician, I value collaboration among leaders in the field and believe it critical to advancing patient care through education. AkebiaShares provides an additional outlet for discussion within the kidney community and is an important aspect of our commitment to improve the lives of people with kidney disease."

    About Akebia Therapeutics

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts.

    Akebia Therapeutics Contact

    Kristen K. Sheppard, Esq.

     

     

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  4. CAMBRIDGE, Mass., June 18, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced David A. Spellman is joining Akebia as its new Senior Vice President, Chief Financial Officer and Treasurer, effective June 29, 2020.

    CAMBRIDGE, Mass., June 18, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced David A. Spellman is joining Akebia as its new Senior Vice President, Chief Financial Officer and Treasurer, effective June 29, 2020.

    AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)" alt="Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)">

    Spellman will join Akebia from Intarcia Therapeutics, Inc., where he is Chief Financial Officer and Chief Business Officer. Spellman brings with him extensive experience in supporting rapid business growth within corporate finance, treasury, financial planning and analysis, and strategic planning, along with a deep appreciation for Akebia and its mission within the kidney community.

    "We're thrilled to welcome Dave to Akebia and believe he will make an immediate impact at this dynamic time in our history," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "He will play an important leadership role as we continue to advance vadadustat, our oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD, and align our financial and business strategies in preparation for the next phase of Akebia's growth story."

    "I can't imagine a more exciting time to join Akebia," said Spellman. "Akebia's unwavering commitment to innovation and advancing patient care is inspiring, and I'm thrilled to become part of it. I look forward to building upon Akebia's financial performance and leading the finance organization for continued success."

    Spellman will succeed Jason A. Amello, who has served as Akebia's Senior Vice President, Chief Financial Officer and Treasurer since 2013. Although Amello is stepping down from the position to pursue other professional interests, he will remain with Akebia for a period of time to ensure a smooth transition of responsibilities to Spellman and will continue to advise the Company as a consultant thereafter.

    "On behalf of the Board and everyone at Akebia, I want to thank Jason for his contributions over the past 7 years.  Jason has been a great leader and colleague who has helped create tremendous value for our Company," said Butler. "Thanks to Jason, we have both a strong finance organization and healthy balance sheet that well position us for the future."

    Spellman has more than 20 years of strategic and operational finance experience in fast growing companies within the biopharmaceutical and healthcare industries. Prior to joining Intarcia, Spellman served as the Chief Financial Officer of Mersana Therapeutics, Inc., a clinical stage antibody drug conjugate company. From February 2006 to March 2018, Spellman served in a series of roles at Vertex Pharmaceuticals, Inc., most recently as Vice President, Corporate, Commercial and International Finance. While at Vertex, Spellman helped establish Vertex's international headquarters, business operations and integrated finance teams in over a dozen countries, and he supported the global pricing, reimbursement and launches of Kalydeco® (ivacaftor) and Orkambi® (lumacaftor/ivacaftor), and the U.S. launch of INCIVEK (telaprevir). Prior to Vertex, Spellman spent four years at Millennium Pharmaceuticals where he held several positions on the Finance team, including operating as a member of the VELCADE ® launch team. Spellman received a B.S. in economics from The Wharton School, University of Pennsylvania.

    About Akebia Therapeutics

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

    About Vadadustat

    Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

    Forward-Looking Statements

    Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding the timing and expected impact of the Chief Financial Officer transition, and Mr. Amello's expected future service to Akebia. The terms "believe," "build," "expect," "look forward," "will" and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-Q for the quarter ended March 31, 2020 and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

    Investor Contact:

    Kristen K. Sheppard, Esq.

     

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  5. CAMBRIDGE, Mass., June 10, 2020 /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 data from an investigational clinical research study on different dose regimens of ferric citrate for the treatment of iron deficiency anemia was presented at the 57th ERA-EDTA Virtual Congress, which took place June 6-9, 2020. For more information about the virtual event, visit: https://www.era-edta.org/en/virtualcongress2020/

    CAMBRIDGE, Mass., June 10, 2020 /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 data from an investigational clinical research study on different dose regimens of ferric citrate for the treatment of iron deficiency anemia was presented at the 57th ERA-EDTA Virtual Congress, which took place June 6-9, 2020. For more information about the virtual event, visit: https://www.era-edta.org/en/virtualcongress2020/

    AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)" alt="Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)">

    The presentation titled, "Different Ferric Citrate Dose Regimens in the Treatment of Iron Deficiency Anaemia in Patients with Non-Dialysis-Dependent CKD: The COMPASS Trial," (Abstract SO050) was presented virtually online at the ERA-EDTA Virtual Congress. The abstract is now available in Nephrology Dialysis Transplantation online here.  

    The COMPASS trial was designed to investigate the efficacy and safety of dosing ferric citrate twice-daily as compared to the current U.S. Food and Drug Administration (FDA) approved dosing of ferric citrate three times daily in adult patients with chronic kidney disease (CKD) not on dialysis. Adult patients were randomized to receive either one ferric citrate tablet three times daily or two ferric citrate tablets twice daily. The presentation will report data through week 24 of the 48-week study.

    Akebia markets ferric citrate in the U.S. as Auryxia® (ferric citrate), which is approved for two indications: the control of serum phosphorus levels in adult patients with CKD on dialysis, and the treatment of iron deficiency anemia in adult patients with CKD not on dialysis.

    This study was funded by Akebia.

    About Akebia Therapeutics

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts.

    About Auryxia® (ferric citrate) Tablets

    Auryxia (ferric citrate) was approved by FDA on September 5, 2014 for the control of serum phosphorus levels in adult patients with CKD on dialysis and approved by FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.  

    IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) CONTRAINDICATION

    AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

    WARNINGS AND PRECAUTIONS

    • Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
    • Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.

    ADVERSE REACTIONS

    Most common adverse reactions with AURYXIA were:

    • Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%).
    • Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%).

    SPECIFIC POPULATIONS

    • Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.

    To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799.

    Please see full Prescribing Information 

    Akebia Therapeutics Contact

    Kristen K. Sheppard, Esq.

     

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