AKBA Akebia Therapeutics Inc.

3.06
-0.1  -3%
Previous Close 3.16
Open 3.17
52 Week Low 2.09
52 Week High 13.71
Market Cap $469,717,451
Shares 153,502,435
Float 134,661,858
Enterprise Value $342,662,694
Volume 2,992,903
Av. Daily Volume 6,784,542
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Drug Pipeline

Drug Stage Notes
Vadadustat
Anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis.
NDA Filing
NDA Filing
NDA filing announced March 30, 2021.
Vadadustat
COVID-19
Phase 3
Phase 3
Phase 3 initiation announced July 14, 2020.
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., April 2, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted 19 newly-hired employees options to purchase an aggregate of 131,000 shares of Akebia's common stock on March 31, 2021, 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., April 2, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted 19 newly-hired employees options to purchase an aggregate of 131,000 shares of Akebia's common stock on March 31, 2021, 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 $3.38 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., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

    CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

    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 submission of the vadadustat NDA for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease," stated John P. Butler, Chief Executive Officer of Akebia. "The Akebia team and our collaborator, Otsuka, did an outstanding job preparing this comprehensive submission, which includes substantial data from over 8,000 patients across 36 clinical trials of vadadustat. We look forward to working with the FDA during the review process, and are excited to continue collaborating with our partners to advance vadadustat for the benefit of patients, subject to regulatory approval."

    Based on standard FDA review timelines, the FDA has a 60-day period to determine whether the NDA is complete and acceptable for review. The Company's NDA submission did not include a Priority Review Voucher.

    Otsuka Pharmaceutical Co. Ltd. (Otsuka) is working in close collaboration with Akebia to prepare a Marketing Authorization Application (MAA) for vadadustat for submission to the European Medicines Agency (EMA), expected this year.

    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 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 recently completed its global Phase 3 clinical development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved and marketed under the tradename Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

    About Anemia due to Chronic Kidney Disease (CKD)  

    Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.

    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 potential for obtaining approval of vadadustat for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis; the impact of the vadadustat NDA submission on Akebia, its partners and patients living with anemia due to CKD; the exact timing of the FDA's confirmation as to whether the NDA is complete and acceptable for review; and the timing of submission of an MAA for vadadustat to the EMA. The terms "expect," "continue," "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, but not limited to: any delays in acceptance and review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing of regulatory filings, including the timing of filing the vadadustat MAA with the EMA; the direct or indirect impact of the COVID-19 pandemic on regulators and on Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; the potential therapeutic benefits, safety profile and effectiveness of vadadustat; the timing and content of advice given and decisions made by regulators, including the FDA and EMA; the potential indications, demand and market potential and acceptance of vadadustat; manufacturing, supply and quality risks; risks associated with hiring, training, management and retention and key personnel changes and transitional periods; the actual funding required to develop and commercialize vadadustat, and to operate Akebia; early termination of any of Akebia's collaborations; Akebia's and its collaborators' ability to satisfy their obligations under Akebia's collaboration agreements; the competitive landscape for vadadustat, if approved; 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 collaborations partners and vendors; expected reliance on third parties, including with respect to the development, manufacturing, supply or commercialization of vadadustat, particularly if approved; Akebia's expectations, projections and estimates regarding its capital requirements; and Akebia's intellectual property position, including its ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-K for the year ended December 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, except as required by law, 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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  3. CAMBRIDGE, Mass., March 25, 2021 /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 National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.

    CAMBRIDGE, Mass., March 25, 2021 /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 National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.

    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.)">

    Abstracts are now available online in the NKF SCM21 Abstract and ePoster Gallery: https://casehippo.com/spa/symposium/national-kidney-foundation-2021-spring-clinical-meetings/event/gallery/browser.

    A poster, titled "A Drug-Drug Interaction Study of Vadadustat Coadministered With Cyclosporine, a P-gp Inhibitor, and Digoxin, a P-gp Substrate" (Poster #171), will present Phase 1 clinical research evaluating the effect of cyclosporine on vadadustat exposure and the effect of vadadustat on the exposure of digoxin (Dig). Vadadustat is Akebia's investigational oral hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), which recently completed its global Phase 3 clinical development program for the treatment of anemia due to chronic kidney disease (CKD) in adult patients both on dialysis and not on dialysis.

    Additional Akebia and Akebia-sponsored posters include:

    In addition, Akebia and Otsuka America Pharmaceutical, Inc., have provided educational grant funding in support of the educational session, titled "Treatment of CKD Related Anemia: The Emerging Role of Hypoxia Inducible Factor Inhibitors," scheduled for Thursday, April 8, 2021 at 12:30 p.m. ET. The session will feature speakers:

    • Jeffrey Berns, M.D., who will serve as facilitator and present, "Pathophysiology CKD Anemia and Current Management Strategies;"
    • Volker Haase, M.D., who will present, "Emerging Therapies for CKD Anemia;" and,
    • Stephen Fishbane, M.D., who will present, "Clinical Trials Update: HIF-PHI."

    NKF SCM21 attendees can visit the Akebia virtual booth at https://www.akebiavirtualexperience.com/.

    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 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 recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

    Investor Contact

    Kristen K. Sheppard, Esq.

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  4. CAMBRIDGE, Mass., March 24, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA),  today announced that its collaboration partner, Japan Tobacco Inc. (JT), received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for an additional indication for Riona® Tablets 250mg (Riona) (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

    CAMBRIDGE, Mass., March 24, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA),  today announced that its collaboration partner, Japan Tobacco Inc. (JT), received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for an additional indication for Riona® Tablets 250mg (Riona) (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

    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.)">

    JT and its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), made a public announcement, which is available here: https://www.jt.com/media/news/2021/pdf/20210323_E2.pdf.   

    In 2014, JT obtained manufacturing and marketing approval for Riona, which is currently distributed by Torii as an oral treatment for improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) both on dialysis and not on dialysis in Japan. Ferric citrate is also approved and marketed in the United States by Akebia as Auryxia® (ferric citrate) for the control of serum phosphorus levels in adult patients with CKD on dialysis and for the treatment of IDA in adult patients with CKD not on dialysis.

    "We congratulate JT and Torii on the expansion of Riona's label and thank them for the work they have done to bring a convenient oral medication to patients with IDA in Japan," said John P. Butler, Chief Executive Officer of Akebia.

    The hyperlinks in this release do not form a part of this release.

    About Auryxia® (ferric citrate) Tablets

    Auryxia (ferric citrate) was approved by the FDA on September 5, 2014 for the control of serum phosphorus levels in adult patients with CKD on dialysis and approved by the 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.

    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.

    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 

    Contact

    Kristen K. Sheppard, Esq.

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  5. CAMBRIDGE, Mass., March 11, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, celebrates World Kidney Day and National Kidney Month with the launch of new initiatives to increase awareness of chronic kidney disease (CKD). As reported by the Centers for Disease Control and Prevention, an estimated 37 million adults in the U.S. are affected by CKD, a progressive, irreversible, and often life-altering, illness.

    CAMBRIDGE, Mass., March 11, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, celebrates World Kidney Day and National Kidney Month with the launch of new initiatives to increase awareness of chronic kidney disease (CKD). As reported by the Centers for Disease Control and Prevention, an estimated 37 million adults in the U.S. are affected by CKD, a progressive, irreversible, and often life-altering, illness.

    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.)">

    Akebia's campaign aims to engage patients, kidney care professionals, the kidney community and employees with the goal of promoting kidney health, honoring kidney patients and applauding those who care for them. To publicly commemorate the month and support the kidney community, Akebia's website features a green National Kidney Month banner and ribbon. Akebia employees are showing their support with customized green ribbon Zoom backgrounds for the month. In addition, Akebia's homepage features interviews with kidney care leaders who discuss the value of increasing attention on kidney disease. Visit www.akebia.com/kidney-disease/ to view a video.

    In conjunction with patient advocacy groups, Akebia is recognizing those who work tirelessly to help kidney patients. In the local community, Akebia is a platinum sponsor of the NKF Honors Gala 2021, an event presented by the National Kidney Foundation serving New England. The Honors Gala, which takes place virtually on Saturday, March 20, recognizes those who have been outstanding in the promotion of kidney health and the fight against kidney disease. In addition, as part of the Company's speaker series, Akebia will host Lori Hartwell, Founder of Renal Support Network, to speak with employees about her experience living with kidney disease.

    "We celebrate National Kidney Month and World Kidney Day to spotlight the importance of kidney health, increase awareness of the disease and thank the healthcare professionals and caregivers who share in our commitment to all patients," said John P. Butler, Chief Executive Officer of Akebia. "We are inspired by patients who face a life-changing diagnosis with the belief that life can be better. Their stories and strength motivate our efforts as we do our part to improve the standard of care for kidney patients. We remain committed to bringing innovation to the kidney community."

    Through its social media channels, Akebia is highlighting patient stories and sharing appreciation for the countless healthcare professionals and caregivers who are dedicated to people living with kidney disease. Akebia encourages patients, caregivers and others to unite, spread the word and capture their support using the hashtags: #NationalKidneyMonth and #WorldKidneyDay.

    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.

    Investor Contact

    Kristen K. Sheppard, Esq.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-therapeutics-celebrates-world-kidney-day-and-national-kidney-month-301245166.html

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