AKBA Akebia Therapeutics Inc.

2.51
+0.12  (+5%)
Previous Close 2.39
Open 2.39
52 Week Low 2.34
52 Week High 13.71
Market Cap $359,726,692
Shares 143,317,407
Float 124,476,830
Enterprise Value $160,751,473
Volume 6,151,207
Av. Daily Volume 5,804,503
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Drug Pipeline

Drug Stage Notes
Vadadustat - PRO2TECT
Non-dialysis patients with anemia related to CKD (NDD-CKD)
Phase 3
Phase 3
Phase 3 trial met efficacy primary endpoint but did not meet primary safety MACE endpoint.
Vadadustat
COVID-19
Phase 3
Phase 3
Phase 3 initiation announced July 14, 2020.
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.
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., Sept. 8, 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 it will participate in the following virtual investor conferences in September. 

    CAMBRIDGE, Mass., Sept. 8, 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 it will participate in the following virtual investor conferences in September. 

    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.)">

    • Citi's 15th Annual BioPharma Conference

      John P. Butler, President and Chief Executive Officer, to participate in virtual one-on-one meetings on Wednesday, September 9.

       
    • H.C. Wainwright 22nd Annual Global Investment Conference

      Michel Dahan, Chief Operating Officer, and David Spellman, Chief Financial Officer, to participate in a virtual fireside chat on Monday, September 14, at 10:00 a.m. ET.

       
    • Morgan Stanley Virtual 18th Annual Global Healthcare Conference

      John P. Butler, President and Chief Executive Officer, to participate in a fireside chat on Tuesday, September 15, at 1:15 p.m. ET.

       
    • Cantor Virtual Global Healthcare Conference

      John P. Butler, President and Chief Executive Officer, to present on Wednesday, September 16, at 1:20 p.m. ET.

    Where applicable, live webcasts of Akebia's presentations will be made available on the Investors section on the Company's website at https://ir.akebia.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.

    Akebia Therapeutics Contact

    Kristen K. Sheppard, Esq.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-therapeutics-announces-september-2020-investor-conference-schedule-301125188.html

    SOURCE Akebia Therapeutics

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  2. CAMBRIDGE, Mass., Sept. 3, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announces top-line results from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis. The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult…

    CAMBRIDGE, Mass., Sept. 3, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announces top-line results from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis. The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

    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.)">

    Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority (NI) to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO2TECT studies.

    Akebia is working to present the full dataset from its global Phase 3 program (INNO2VATE and PRO2TECT) at an upcoming medical conference and publish the data in peer reviewed journals. Akebia plans to submit to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd., are working in close collaboration to prepare a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA).

     "We remain confident that we have a path toward potential approval for vadadustat in dialysis supported by positive top-line results for efficacy and safety from INNO2VATE.  PRO2TECT delivered positive top-line efficacy results; however, the MACE result presents challenges to achieving our goal of bringing vadadustat to patients in the non-dialysis market. While achieving the MACE endpoint would have made our path here more straightforward, as it is in dialysis, we still believe we have a path toward approval for vadadustat in non-dialysis," stated John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "We believe the cardiovascular safety of vadadustat is supported by the totality of the data from our global Phase 3 program, including additional analyses on cardiovascular outcomes observed within key geographic regions and across certain patient sub-populations within PRO2TECT."

    Butler continued, "With data in hand, we and Otsuka have already started working on vadadustat's NDA. At this time, we're planning for a pre-NDA meeting with the FDA before the end of the year, followed by our NDA filing for both the dialysis and non-dialysis indications as early as possible next year. Together with Otsuka, we believe we have an extensive data package to support the potential approval of vadadustat in both indications. We look forward to putting this package in front of health authorities as soon as possible and sharing the full dataset from our global Phase 3 program at an upcoming medical conference."  

    Global Phase 3 PRO2TECT Program

    Akebia's global PRO2TECT program is a cardiovascular outcomes program that includes two separate Phase 3 studies (Correction and Conversion), which collectively enrolled 3,476 adult patients not on dialysis with anemia due to CKD. Both PRO2TECT studies are global, multicenter, open label (sponsor blinded), active-controlled (darbepoetin alfa - an injectable erythropoiesis stimulating agent (ESA)), non-inferiority studies. In both studies, patients were randomized 1:1 to receive either vadadustat or darbepoetin alfa. Vadadustat was initiated at a starting oral dose of 300 mg once daily and adjusted over time in increments of 150 mg within the range of 150 to 600 mg daily using a dose adjustment algorithm, while darbepoetin alfa was dosed per the U.S. package insert (USPI) or summary of product characteristics (SmPCs) in appropriate geographies.

    The PRO2TECT Correction study evaluated 1,751 patients with anemia due to CKD without recent ESA use (879 and 872 patients randomized to vadadustat and darbepoetin alfa, respectively). The PRO2TECT Conversion study evaluated 1,725 patients with anemia due to CKD on an active ESA treatment (862 and 863 patients randomized to vadadustat and darbepoetin alfa, respectively).

    In both PRO2TECT studies, the primary efficacy endpoint was the mean change in Hb between baseline and the primary evaluation period (weeks 24-36). Non-inferiority was achieved if the lower bound of the 95% confidence interval (CI) for the between-group difference of the mean Hb change did not fall below the pre-specified NI margin (-0.75 g/dL). The PRO2TECT program's primary safety endpoint, MACE, was independently and blindly assessed by the Brigham and Women's Hospital's Clinical Endpoint Center (BWH CEC) in Boston, MA, with a comparison of vadadustat to darbepoetin alfa. MACE is defined as the composite endpoint of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. To assess MACE, a combined analysis of time to first MACE event from the two PRO2TECT studies was performed. NI was achieved if the upper bound of the 95% confidence interval for the hazard ratio of vadadustat to darbepoetin alfa did not exceed the pre-specified NI margin of 1.25.

    Primary and Key Secondary Efficacy Endpoint Results

    Vadadustat achieved each of the PRO2TECT studies' primary efficacy endpoints of mean change in Hb between baseline and the primary evaluation period (mean Hb from weeks 24 to 36) compared to darbepoetin alfa, in adult patients on dialysis, demonstrating non-inferiority to darbepoetin alfa using an NI margin of -0.75 g/dL prospectively agreed to with FDA and EMA.

    In PRO2TECT's Correction study (n=1,751):

    • Primary Efficacy Endpoint Result: Vadadustat was non-inferior to darbepoetin alfa. The least square mean difference in Hb was 0.05 g/dL (95% CI: -0.04, 0.15), achieving the pre-specified NI criterion of -0.75 g/dL. The mean (SD) Hb level at week 24 to week 36 was 10.39 (0.99) g/dL for vadadustat-treated patients compared to 10.35 (1.03) g/dL for darbepoetin alfa-treated patients.
    • Key Secondary Efficacy Endpoint Result: Vadadustat sustained the target Hb efficacy response at weeks 40 to 52 achieving non-inferiority compared to darbepoetin alfa. The least square mean difference in Hb was 0.04 g/dL (95% CI: -0.06, 0.14). The mean (SD) Hb level at week 40 to week 52 was 10.48 (1.05) g/dL for vadadustat-treated patients compared to 10.45 (1.01) g/dL for darbepoetin alfa-treated patients.

    In PRO2TECT's Conversion study (n=1,725):

    • Primary Efficacy Endpoint Result: Vadadustat was non-inferior to darbepoetin alfa. The least square mean difference in Hb was -0.01 g/dL (95% CI: -0.09, 0.07), achieving the pre-specified NI criterion of -0.75 g/dL. The mean (SD) Hb level at week 24 to week 36 was 10.77 (0.98) g/dL for vadadustat-treated patients compared to 10.77 (0.99) g/dL for darbepoetin alfa-treated patients.
    • Key Secondary Efficacy Endpoint Result: Vadadustat sustained efficacy in the Conversion study demonstrating non-inferiority to darbepoetin with a least square mean difference in Hb of 0.00 g/dL (95% CI: -0.10, 0.09). The mean (SD) Hb level at week 40 to week 52 was 10.80 (1.04) g/dL in the vadadustat-treated patients compared to 10.79 (1.05) g/dL for darbepoetin alpha-treated patients.

    Primary Safety MACE Endpoint Result

    The PRO2TECT program (Correction and Conversion studies) (n=3,471):

    • Primary Safety MACE Endpoint Result: Vadadustat did not meet the PRO2TECT program's primary safety endpoint of non-inferiority for MACE. The upper bound of the 95% confidence interval of the Hazard Ratio (HR) was above the pre-specified NI margin of 1.25 for primary MACE analysis (HR 1.17, 95% CI: 1.01, 1.36). MACE is defined as the composite endpoint of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke.

    The incidence of treatment emergent adverse events during the Correction study in the vadadustat-treated patients was 90.9%, and 91.6% in darbepoetin alfa-treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa-treated patients were end-stage renal disease (34.7%/ 35.2%), hypertension (17.7%/ 22.1.%), hyperkalemia (12.3.%/ 15.6%), urinary tract infection (12.9%/ 12.0%), diarrhea (13.9%/ 10.0%), peripheral oedema (12.5%/ 10.5%), fall (9.6%/ 10%) and nausea (10%/ 8.2%). Serious treatment emergent adverse events were 65.3% for vadadustat-treated patients and 64.5% for darbepoetin alfa-treated patients. The incidence of treatment emergent adverse events during the Conversion study in vadadustat treated patients was 89.1% and 87.7% in darbepoetin alfa-treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa-treated patients were end-stage renal disease (27.5%/ 28.4%), hypertension (14.4%/ 14.8%), urinary tract infection (12.2%/ 14.5%), diarrhea (13.8.%/ 8.8.%), peripheral oedema (9.9%/ 10.1%) and pneumonia (10.0%/ 9.7%). Serious treatment emergent adverse events were 58.5% for vadadustat-treated patients and 56.6% for darbepoetin alfa-treated patients.

    "The results of Akebia's global Phase 3 program continue to underscore the potential of vadadustat as a once-daily oral standard of care for patients living with anemia due to CKD, upon approval," stated Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia Therapeutics. "There is a significant unmet medical need among patients living with anemia due to CKD, and we are excited to be advancing vadadustat as a potential therapy for these patients. I would like to extend our sincere thanks to everyone involved in this study, including the patients, physicians, investigators and their staff."

    Investor Conference Call and Live Webcast:

    Akebia will host a conference call with accompanying slides today, Thursday, September 3, 2020, at 8:30 a.m. Eastern Time to discuss the PRO2TECT data. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 9547389. A live webcast of the call with accompanying slides can be accessed via the Investors section of the Company's website at https://ir.akebia.com/.

    A replay of the conference call will be available two hours after the completion of the call through September 9, 2020. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 9547389. A replay of the webcast, and accompanying slides, can be accessed via the Investors section of the Company's website at https://ir.akebia.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 is in global Phase 3 development for the treatment of anemia due to CKD and 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.

    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 Akebia's belief that the totality of the data from its global Phase 3 program for vadadustat supports the cardiovascular safety of vadadustat, an NDA submission and marketing approval in both the dialysis and non-dialysis indications; the path for approval of vadadustat in dialysis and non-dialysis; the potential challenges with respect to achieving an approval for vadadustat in the non-dialysis indication; the assessment of the data from  PRO2TECT, including additional analyses on cardiovascular outcomes observed within key geographic regions and across certain patient sub-populations; the potential for marketing approval of vadadustat in dialysis and non-dialysis; the Company's goal of bringing vadadustat to patients in the dialysis and non-dialysis markets; the timing of meetings with regulators, including the pre-NDA meeting with the FDA; safety and efficacy of vadadustat; the potential indications for and benefits of vadadustat; sharing vadadustat clinical data, including the full dataset from INNO2VATE and PRO2TECT, at an upcoming medical conference, in peer reviewed journals and with health authorities and others, as well as the timing and forum thereof; submitting filings for marketing approval of vadadustat, and the timing thereof; the potential launch and commercialization of vadadustat if approved by regulatory authorities; and market opportunity, clinical opportunity, commercial potential, prevalence, and the growth in, and potential demand for, vadadustat. The terms "advance," "believe," "goal," "look forward," "opportunity," "planned," "potential," "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 the timing and content of advice given and decisions made by health authorities, including marketing approval and labeling decisions; the actual time it takes to make regulatory submissions for vadadustat to health authorities, including the submission of the NDA to the FDA and the MAA to EMA; risks associated with the Priority Review Voucher for vadadustat; the potential direct or indirect impact of the COVID-19 pandemic on our business, operations, and the markets and communities in which we and our partners, collaborators, vendors and customers operate; manufacturing and quality risks; risks associated with management and key personnel changes and transitional periods; the actual funding required to continue to commercialize our commercial product, develop and commercialize vadadustat and operate the Company; market acceptance and coverage and reimbursement of our commercial product and vadadustat, if approved; the risks associated with potential generic entrants for our commercial product and vadadustat, if approved; 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 our commercial product and vadadustat; 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 ability to obtain, maintain and enforce patent and other intellectual property protection for our commercial product, vadadustat and any other product candidates. 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 June 30, 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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-therapeutics-announces-top-line-results-from-its-pro2tect-global-phase-3-program-of-vadadustat-for-treatment-of-anemia-due-to-chronic-kidney-disease-in-adult-patients-not-on-dialysis-301123808.html

    SOURCE Akebia Therapeutics

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  3. CAMBRIDGE, Mass., Sept. 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 10 newly-hired employees options to purchase an aggregate of 54,000 shares of Akebia's common stock on August 31, 2020, 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., Sept. 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 10 newly-hired employees options to purchase an aggregate of 54,000 shares of Akebia's common stock on August 31, 2020, 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 $10.41 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.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301123185.html

    SOURCE Akebia Therapeutics

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  4. CAMBRIDGE, Mass., Aug. 26, 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 vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO. VAFSEO has been included in the Japan National Health Insurance drug price listing and was granted regulatory approval 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 in June 2020. The starting dose for…

    CAMBRIDGE, Mass., Aug. 26, 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 vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO. VAFSEO has been included in the Japan National Health Insurance drug price listing and was granted regulatory approval 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 in June 2020. The starting dose for VAFSEO is indicated at 300 mg with a maximum dose indicated at 600 mg.

    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.)">

    VAFSEO provides adult patients in Japan with a once-daily treatment option and has the potential to set a new oral standard of care for the treatment of renal anemia in Japan. 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. Anemia due to CKD can result in serious complications including irregular or unusually fast heartbeat, enlargement of the heart, and heart failure and also has well-documented impacts on quality of life. Injectable erythropoiesis-stimulating agents (ESAs) are currently the standard of care.

    In 2015, Akebia and Mitsubishi Tanabe Pharma Corporation (MTPC) entered into a collaboration agreement that provided MTPC with exclusive rights to develop and commercialize vadadustat in Japan and certain other Asian countries. Under the terms of the agreement, Akebia is eligible to receive up to approximately $190 million in future milestone payments from MTPC, based upon achievement of certain regulatory and sales milestones. MTPC is also obligated to 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.

    Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not yet approved outside of Japan.

    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 is in global Phase 3 development for the treatment of anemia due to CKD and 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.

    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 the commercialization of VAFSEO in Japan, prevalence of CKD, and related milestone and royalty payments. 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 and material contracts; Akebia's and its collaborators' ability to satisfy their obligations under Akebia's collaboration agreements and material contracts; 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 June 30, 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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-therapeutics-announces-first-commercial-launch-of-vafseo-vadadustat-tablets-a-new-oral-treatment-for-anemia-due-to-chronic-kidney-disease-in-japan-301118420.html

    SOURCE Akebia Therapeutics

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  5. CAMBRIDGE, Mass., Aug. 10, 2020 /PRNewswire/ --

    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.)">

    • Top-line data readout of global Phase 3 PRO2TECT program of vadadustat for treatment of anemia due to CKD in adult patients not on dialysis on track for early September
    • Cash runway extends beyond expected U.S. launch of vadadustat

    Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today reported financial results for the second quarter ended June 30, 2020. As previously announced, in lieu of a financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, the Company's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.

    "We had an incredible quarter in terms of advancing our vadadustat clinical development program, bringing us that much closer to achieving our purpose to better the life of each person impacted by kidney disease. We reported exciting, positive top-line data from our global Phase 3 INNO2VATE program highlighting vadadustat's potential as a new oral standard of care for treating anemia due to CKD in adult patients on dialysis, and topped off the quarter with the first regulatory approval of vadadustat in Japan," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The next chapter of Akebia's growth story is starting to unfold and as previously announced, we plan to share top-line data from PRO2TECT in early September."  

    Recent Business Highlights

    • In August, the Company announced database lock for PRO2TECT and plans to report top-line data from PRO2TECT in early September. This announcement follows Akebia's earlier update provided in May that it had achieved the target number of major adverse cardiovascular events (MACE) for the PRO2TECT studies.
    • In July, the Company announced an investigator-sponsored research study by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection.
    • In June, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia's collaboration partner in Japan for vadadustat, obtained the first regulatory approval of vadadustat (Japan trade name: VAFSEO™), 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.
    • In May, the Company reported positive top-line data from INNO2VATE, the first of its two global Phase 3 cardiovascular outcomes programs, which evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat showed consistency across both efficacy and all MACE components, achieving the primary efficacy and safety endpoints, as well as the key secondary efficacy endpoint, of the studies. Please refer to Akebia's INNO2VATE Data Announcement for the top-line data.
    • In May, the Company completed a public offering of its common stock raising net proceeds of $142.4 million.
    • In May, the Company announced that its collaboration partner, Japan Tobacco, Inc., filed a supplemental New Drug Application with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona® (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

    Second Quarter Financial Results

    • Revenues: Total revenue was $90.1 million for the second quarter of 2020 compared to $100.8 million for the second quarter of 2019. The decline versus the prior year period was driven by lower collaboration revenue consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.
      • Collaboration revenue was $59.4 million for the second quarter of 2020 compared to $71.7 million in the second quarter of 2019.
      • Net product revenue for Auryxia® (ferric citrate) was $30.7 million for the second quarter of 2020 compared with $29.1 million in the second quarter of 2019, an increase of 5.5 percent.
    • COGS: Cost of goods sold increased $136.9 million compared to the prior year period primarily due to a non-cash impairment charge of $115.5 million related to Auryxia, and higher non-cash inventory write-downs, which included $12.4 million largely related to a manufacturing quality issue related to Auryxia identified in the second quarter of 2020.
    • R&D Expenses: Research and development expenses were $52.8 million for the second quarter of 2020 compared to $85.7 million for the second quarter of 2019. The decline versus the prior year period was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.
    • SG&A Expenses: Selling, general and administrative expenses were $35.5 million for the second quarter of 2020 compared to $36.1 million for the second quarter of 2019.
    • Net Loss: Net loss was $175.8 million for the second quarter of 2020 compared to $58.2 million for the second quarter of 2019. The increase in net loss compared to the prior year period was due primarily to the non-cash impairment charge and higher non-cash inventory write-downs.
    • Cash Position: Cash, cash equivalents and available-for-sale securities as of June 30, 2020 were $295.3 million. The increase in the Company's cash position is primarily attributable to net proceeds of $142.4 million from Akebia's public offering of common stock, which was completed in May 2020. The Company believes that its cash runway extends beyond the expected U.S. launch of vadadustat.

    "The non-cash impairment charge reflects the change in value of the Auryxia intangible asset on our balance sheet, primarily driven by the compounding impact of the 2018 decision by the Centers for Medicare and Medicaid Services (CMS) rescinding Medicare Part D coverage of Auryxia for its IDA indication and imposing a prior authorization requirement for the hyperphosphatemia indication," stated David A. Spellman, Chief Financial Officer of Akebia Therapeutics. "While we are frustrated and disappointed that a resolution has not been reached on this matter for the benefit of patients, we remain optimistic about Auryxia's growth prospects."

    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 is in global Phase 3 development for the treatment of anemia due to CKD and 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.

    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 (the "hyperphosphatemia indication") and approved by FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis (the "IDA indication"). For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.  

    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.

    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

    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 plans to report top-line data from PRO2TECT and the anticipated timing thereof; Akebia's growth story and growth prospects; the safety and efficacy of vadadustat and the potential indications for and benefits of vadadustat; and estimates, beliefs and judgments related to the impairment charge, including the drivers thereof. The terms "anticipate," "believe," "expect," "opportunity," "planned," "potential," "target," "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 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; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials, including PRO2TECT; the risk that clinical trials may not be successful; manufacturing risks; risks associated with the Priority Review Voucher for vadadustat; risks associated with management and key personnel changes and transitional periods; the actual funding required to develop and commercialize our commercial product, vadadustat and other product candidates and operate the Company, and the actual expenses associated therewith; the actual costs incurred in the clinical studies of vadadustat and the availability of financing to cover such costs; the risk that clinical studies are discontinued or delayed for any reason, including for safety, tolerability, enrollment, manufacturing or economic reasons; market acceptance and coverage and reimbursement of our commercial product and vadadustat; the risks associated with potential generic entrants for our commercial product and vadadustat; early termination of any of Akebia's collaborations and material contracts; Akebia's and its collaborators' ability to satisfy their obligations under Akebia's collaboration agreements and material contracts; the timing and content of decisions made by regulatory authorities; the timing of any additional studies initiated for vadadustat; the actual time it takes to initiate and complete preclinical and clinical studies; the competitive landscape for our commercial product and vadadustat; 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 ability to obtain, maintain and enforce patent and other intellectual property protection for our commercial product, vadadustat and any other product candidates. 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.

    Investor Contact:

    Kristen K. Sheppard, Esq.

     

    AKEBIA THERAPEUTICS, INC.

    Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)











    Three Months Ended



    Six Months Ended



    June 30, 2020



    June 30, 2019



    June 30, 2020



    June 30, 2019

















    Revenues:















    Product revenue, net

    $

    30,696





    $

    29,089





    $

    59,905





    $

    52,200



    License, collaboration and other

    revenue

    59,446





    71,714





    118,715





    121,269



    Total revenues

    90,142





    100,803





    178,620





    173,469



    Cost of goods sold:















    Product

    49,988





    28,569





    68,601





    50,726



    Amortization of intangibles

    9,101





    9,100





    18,201





    18,200



    Impairment of intangible asset

    115,527









    115,527







    Total cost of goods sold

    174,616





    37,669





    202,329





    68,926



    Operating expenses:















    Research and development

    52,819





    85,694





    134,050





    168,045



    Selling, general and administrative

    35,482





    36,068





    73,465





    70,359



    License expense

    1,044





    895





    1,720





    1,631



    Total operating expenses

    89,345





    122,657





    209,235





    240,035



    Operating loss

    (173,819)





    (59,523)





    (232,944)





    (135,492)



    Other income (expense), net

    (1,932)





    508





    (3,554)





    1,299



    Net loss before income taxes

    (175,751)





    (59,015)





    (236,498)





    (134,193)



    Benefit from income taxes





    (845)









    (3,602)



    Net loss

    $

    (175,751)





    $

    (58,170)





    $

    (236,498)





    $

    (130,591)



    Net loss per share - basic and diluted

    $

    (1.28)





    $

    (0.49)





    $

    (1.78)





    $

    (1.11)



    Weighted-average number of common

    shares - basic and diluted

    136,906,968





    118,268,832





    132,651,066





    117,669,422



     

    AKEBIA THERAPEUTICS, INC.

    Selected Balance Sheet Data

    (in thousands)

    (unaudited)





    June 30, 2020



    December 31, 2019

    Cash, cash equivalents and available for sale securities

    $295,349



    $147,694

    Working capital

    253,328



    101,415

    Total assets

    745,174



    771,201

    Total stockholders' equity

    370,260



    394,757

     

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