Nakhoul G, Simon JF. Stauffer ME, Fan T. Prevalence of Anemia in Chronic Kidney Disease in the United States. Kidney Int Suppl 2012;2(4):279–335. Anemia of chronic kidney disease: Treat it, but not too aggressively. Information on these pages contains forward-looking statements that involve risks and uncertainties. While there are treatment options, unmet needs remain and undertreatment continues to be a challenge. Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. We aim to add to our pipeline and portfolio of treatment for renal diseases through internal discovery and development, and through strategic transactions, such as in-licenses, collaborations and acquisitions. Tesla shares suffer in Friday's pre-market as reports of a fire at its Fremont factory. Within Japan, Vadadustat, which completed its global Phase 3 program for the treatment of anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, and will be marketed by Mitsubishi Tanabe … CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. Akebia Therapeutics Inc ... And FDA can determine that the drug is approved for both populations or just for one. 4. Akebia Therapeutics Announces Submission of Vadadustat New Drug Application in Japan for Anemia Due to Chronic Kidney Disease by Collaboration Partner, MTPC. The GBP/USD pair settled around 1.3920 on Friday, down for the day but up for the week. Vadadustat is intended to be a treatment for patients with CKD or Chronic Kidney Disease who are also afflicted with anaemia. Akebia’s privacy procedures do not apply to the owners of a non-Akebia website. MTPC filed a Japanese New Drug Application for vadadustat in July 2019. These efforts are guided by our purpose to better the life of each person impacted by kidney disease. Anemia is a condition in which a person does not have enough healthy red blood cells to carry adequate oxygen to the body’s tissues. N Engl J Med 2006; 355(20):2071–2084. The EUR/USD pair finished the week with modest gains in the 1.1950 price zone, as demand for the greenback eased heading into the weekend, despite US Treasury yields reached fresh one-year highs. N Engl J Med 2009; 361(21):2019–2032. DOI: 10.1186/1471-2369-14-2. You are leaving akebia.com, a website of Akebia Therapeutics, Inc. Akebia does not review or control the content of non-Akebia websites, and this hyperlink does not constitute an endorsement by Akebia of the site’s content. Vadadustat is an oral HIF-PHI in clinical development for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent adult patients. We are optimistic and want to have a positive impact. Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT). Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA). Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Singh AK, Szczech L, Tang KL, et al; CHOIR Investigators. You should do your own thorough research before making any investment decisions. Trading foreign exchange on margin carries a high level of risk and may not be suitable for all investors. DOI: 10.1038/nrd4422. Majmundar AJ, Wong WJ, Simon MC. It can commonly occur in people with chronic kidney disease (CKD) because their kidneys do not produce enough erythropoietin (EPO), which is a hormone released into the blood to help regulate the production of red blood cells. Veklury had previously received emergency use authorization from the FDA for treating COVID-19 patients. Additional information is available here: https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-inno2vate-global-phase-3-program. Portoles J, Gorriz JL, Rubio E, et al. The announcement that Akebia’s drug Vadadustat had not passed certain safety requirements in the late stages of a clinical trial brought immediate red-flags up for the investment community. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Vifor Pharma has struck a deal to buy a priority review voucher (PRV). 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 … For more information, please visit our … Akebia reported that patients who took Vadadustat were shown to have increased heart risks, especially when compared to a similar treatment made by rival Amgen (NASDAQ:AMGN). U.S. National Library of Medicine. DOI:10.1371/journal.pone.0084943. Am J Physiol Renal Physiol 2006;291(2):F271-281. Injectable erythropoiesis-stimulating agents (ESAs) have been the standard of care for treating anemia due to CKD in both dialysis dependent and non-dialysis dependent patients since the early 1990s. While there are treatment options, unmet needs remain and undertreatment continues to be a challenge. You should be aware of all the risks associated with foreign exchange trading and seek advice from an independent financial advisor if you have any doubts. 17. 15. In 2020, we announced results from the INNO2VATE program for vadadustat in adult patients on dialysis (incident and prevalent dialysis patients). FXStreet does not in any way guarantee that this information is free from mistakes, errors, or material misstatements. 6. Accessed: September 20, 2019. Some bargain investors may see this as a potential buying opportunity with the company determined to march on with its quest for FDA approval. CAMBRIDGE, Mass., March 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 five newly-hired employees options to purchase an aggregate of 44,000 shares of Akebia's common stock on February 26, 2021, as inducements material to each such employee's … HIF-PHIs  are designed to mimic the body’s response to lower levels of oxygen, such as when a person is at high altitude. Akebia Therapeutics was founded in 2007 and it’s primary goal is to achieve better outcomes for people with kidney disease. So that kind of, I think, makes your second question moot. GBP/USD bearish potential increased after a series of dismal macroeconomic readings. 1. Mol Cell 2010;40(2):294-309. 8. Accessed: September 20, 2019. Tesla shares rebound from below $600 on March 5 to near $700. Accessed: September 20, 2019. 23, 2019-- Akebia Therapeutics, Inc. … Akebia shares rights to vadadustat with Otsuka and Mitsubishi Tanabe Pharma. The drug has been on the market for quite some time, having received FDA approval for the hyperphosphatemia indication in September 2014, and then receiving a … 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). Akebia and its partner, Japanese drugmaker Otsuka, plan to meet with the FDA before the end of 2020. 12. For the latest Akebia corporate presentation, please visit Akebia’s Investors page. In addition, Mitsubishi Tanabe Pharma Corporation (MTPC), our development and commercialization collaboration partner in Japan and certain other Asian countries for vadadustat, obtained 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. Pfeffer MA, Burdmann EA, Chen CY, et al; TREAT Investigators. Within Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. Anemia in Chronic Kidney Disease. Improve your trading results with FXStreet Premium! Our lead product candidate, vadadustat, is part of a new class of investigational agents called oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which are based on Nobel Prize-winning science. Approximately number* of people with CKD affected by anemia in the U.S. alone. DOI: 10.1016/j.molcel.2010.09.022. GBP/USD is neutral in the near-term, could accelerate south once below 1.3865. Available at: https://www.niddk.nih.gov/health-information/kidney-disease/anemia. The companies intend to submit for U.S. regulatory approval of vadadustat in the dialysis … A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. DOI: 10.1056/NEJMoa0907845. © 2021 Akebia Therapeutics, Inc. All rights reserved. The Unemployment Rate in Canada dropped to 8.2% in February from 9.4% in January and came in much better than the market expectation of 9.2%. Akebia Therapeutics Inc (NASDAQ:AKBA) ... Gilead said the FDA approved its antiviral drug Veklury (remdesivir) for the treatment of adults and pediatric patients, 12 years of age and older and weighing at least 40 kg, with COVID-19 and requiring hospitalization. 10. AKBA currently has a drug released globally called Auryxia that controls the serum phosphorus levels in adult patients with chronic kidney disease on dialysis and also treats iron deficiency for these patients. *Based on third party prevalence data and company estimates. Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE). We also announced results from the PRO2TECT program for vadadustat in adult patients not on dialysis. Nat Rev Drug Discov 2014;13(11):852-869. The drug is already under review in Japan. Each day we bring our drive to life with the work we do. Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE). Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. FXStreet will not accept liability for any loss or damage, including without limitation to, any loss of profit, which may arise directly or indirectly from use of or reliance on such information. Additional information is available here: https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-pro2tect-global-phase-3-program. The PRV sets Vifor and partner Akebia Therapeutics up to benefit from a fast review at the FDA when they file for approval … U.S. National Library of Medicine. The CFTC is investigating Binance on whether the exchange allowed U.S. residents to buy or sell derivatives as Binance isn't registered with the agency. N Engl J Med 1998;339(9):584–590. Investing in Open Markets involves a great deal of risk, including the loss of all or a portion of your investment, as well as emotional distress. First Regulatory Approval for Akebia's HIF-PHI Marks Beginning of Next Phase of Akebia's Growth Story. Here at Akebia, we are leading a change by working to advance innovative therapies to better the lives of people living with kidney disease. Note: All information on this page is subject to change. Accessed: September 20, 2019. The website you are being directed to is intended for healthcare professionals (HCPs). The body naturally responds to lower oxygen levels by increasing the availability of HIF, which is a protein that coordinates the expression of the genes responsible for erythropoietin synthesis and the regulation of iron metabolism. Correction of anemia with epoetin alfa in chronic kidney disease. U.S. National Library of Medicine. Haase VH. 16. You are now leaving Akebia's Virtual Experience. Hypoxia-inducible factors and the response to hypoxic stress. Data Bridge Market research presents the top quality and comprehensive Iron-deficiency anemia therapy research report which provides clear insights in The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of FXStreet nor its advertisers. VIFOR PHARMA AND AKEBIA THERAPEUTICS ANNOUNCE EXPANSION OF LICENCE AGREEMENT Expanded licence creates opportunity for vadadustat to be provided to up to 60% of U.S. dialysis patients, subject to FDA approval The Vifor Pharma Group (SIX: VIFN) and Akebia Therapeutics, Inc. (Nasdaq: AKBA) today announced that the companies have amended the terms of … 11. Shares had been up 56% since the beginning of the year – but the one-day loss on Thursday erased all of its gains and the stock is now down nearly 60% year-to-date. Please read our privacy policy and legal disclaimer. The drug, which is the only FDA-approved treatment for COVID-19, is now widely available in hospitals across the country, Gilead said. Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. In after … Available at: https://clinicaltrials.gov/ct2/show/NCT02892149. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™. We thrive as collaborators because we believe that we can go further together. 2013;14:2. U.S. National Library of Medicine. 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. Accessed: September 20, 2019. July 23, 2019 at 4:00 AM EDT. 14. 15 May 2017. https://akebia.com/. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. The company plans to file approval applications in the U.S. and Europe "as quickly as possible" pending positive results, CEO John Butler said in a statement. The possibility exists that you could sustain a loss of some or all of your initial investment and therefore you should not invest money that you cannot afford to lose. EUR/USD is technically neutral in the near-term, has a limited bullish scope. We believe new treatment options for anemia are not only needed, but also possible. Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT). Anemia affects approximately 5.7 million people with CKD in the U.S. alone. U.S. National Library of Medicine. 13. All risks, losses and costs associated with investing, including total loss of principal, are your responsibility. The crypto market saw an instant drop after the announcement, with BNB taking the biggest hit, down 10%. We work with partners across the globe to pioneer and grow new areas of research and development. Available at: https://clinicaltrials.gov/ct2/show/NCT02648347. 7. Opinions expressed at FXStreet are those of the individual authors and do not necessarily represent the opinion of FXStreet or its management. Accessed: September 20, 2019. JNDA Submission Represents First Regulatory Submission for Marketing Approval of Vadadustat . Drüeke TB, Locatelli F, Clyne N, et al; CREATE Investigators. Available at: https://clinicaltrials.gov/ct2/show/NCT02865850. Markets and instruments profiled on this page are for informational purposes only and should not in any way come across as a recommendation to buy or sell in these assets. If you would like to learn more about our clinical trials, including becoming a participating  investigator or referring physician, please email trials@akebia.com or visit www.clinicaltrials.gov, and input “vadadustat” into the “Other terms” search bar. Akebia Therapeutics, Inc. 245 First Street, Suite 1400 Cambridge, MA 02142, +1 617.871.2098  phone +1 617.871.2099  fax. The high degree of leverage can work against you as well as for you. 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 … Targeting hypoxia signalling for the treatment of ischaemic and inflammatory diseases. Teslas shares rally strongly from recent lows as tech recovers. While CEO John Butler has insisted that the biotech firm will push forward to seek FDA approval for the drug, investors are clearly not as enthusiastic about Vadadustat’s chances of becoming a viable treatment option. Eltzschig HK, Bratton DL, Colgan SP. Available at: https://clinicaltrials.gov/ct2/show/NCT02648347. Cleve Clin J Med 2016;83(8):613-624. A quick look at the trading volume since Thursday shows a high amount of action with over 33 million shares being traded as opposed to the average trading volume of just over 2 million shares. 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. That timeline would put Akebia and Vifor roughly six months behind AstraZeneca and Fibrogen, which have a similar anemia drug set to receive an approval decision by Dec. 20, 2020. 5. Within Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. Recent late-stage clinical studies of its drug Vadadustat revealed safety issues as the company prepares for FDA submission. 3. N Engl J Med 2006;355(20):2085–2098. https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-inno2vate-global-phase-3-program, https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-pro2tect-global-phase-3-program, Note Regarding Forward Looking Statements. Why Anemia?    /    Innovating to Protect the Kidneys    /    Clinical Development   /   Other Research Programs. Inhibition of hypoxia-inducible factor prolyl hydroxylase (HIF-PH) can lead to increased red blood cell production and improved oxygen delivery to tissues. AKBA’s announcement was unexpected and the sudden plunge of its stock price reflects that. Akebia Therapeutics presented additional data from its Phase III PRO2TECT trial at the 2020 American Society of Nephrology Kidney Week conference, that evaluated the efficacy and safety of vadadustat versus erythropoiesis stimulating agent (ESA) Aranesp (darbepoetin alfa) for the treatment of chronic kidney disease (CKD) anemia in adult non-dialysis patients. It also does not guarantee that this information is of a timely nature. Â. At Akebia, we are inspired to think boldly and move bold thinking into action. Before deciding to trade foreign exchange you should carefully consider your investment objectives, level of experience and risk appetite. Besarab A, Bolton WK, Browne JK, et al. Tesla shares fall in pre-market, fire in Fremont factory reported. National Institute of Diabetes and Digestive and Kidney Diseases. For more information, please visit our website at www.akebia.com. Kidney Disease: Improving Global Outcomes (KDIGO) Work Group. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. Vadadustat is a treatment for anemia associated with chronic kidney disease oral HIF inhibitor, is an American biopharmaceutical company Akebia Therapeutics invention in the research of new drugs, has completed Phase II pivotal clinical trial treatment studies, successfully met the researchers set given the level of hemoglobin in vivo target and good security, a significant effect, and phase III clinical … The information is provided for educational purpose only and is not intended to be promotional nor provide medical advice. It certainly has been a nightmare of a week for Akebia (NASDAQ:AKBA) investors as the sudden news of late-stage clinical safety issues sent the stock tumbling down over 70% during Thursday’s trading session. The website may include information about products that are not approved by the US Food and Drug Administration (FDA). We are evaluating the safety and efficacy of vadadustat in two global Phase 3 programs – INNO2VATE (dialysis) and PRO2TECT (non-dialysis). We leverage our scientific expertise and this innovative thinking to develop clinical advances in areas that are important to people living with kidney disease. Left untreated, anemia deteriorates patient health and is associated with increased morbidity and mortality in people with CKD. PLoS One 2014;9(1):e84943. EUR/USD: Yields likely to keep rising and backing the dollar, Canada Unemployment Rate drops to 8.2%, +259K Net Change in Employment, Crypto market tumbles as the CFTC reportedly opens investigation into Binance. Akebia Therapeutics, Inc. AKBA ... Management believes that data from the INNO2VATE and PRO2TECT will support the new drug application (NDA) for vadadustat to … 2. Auryxia (ferric citrate) was approved by the FDA on September 5, 2014, for the control of serum phosphorus levels in adult patients with chronic kidney disease on … Normalization of hemoglobin level in patients with chronic kidney disease and anemia. Expanded licence creates opportunity for vadadustat to be provided to up to 60% of U.S. dialysis patients, subject to FDA approval. Available at: https://clinicaltrials.gov/ct2/show/NCT02680574. FXStreet has not verified the accuracy or basis-in-fact of any claim or statement made by any independent author: errors and Omissions may occur.Any opinions, news, research, analyses, prices or other information contained on this website, by FXStreet, its employees, partners or contributors, is provided as general market commentary and does not constitute investment advice. DOI: 10.3949/ccjm.83a.15065. I mean it's -- … 9. BMC Nephrol. Clinical Development. Analysts at Piper Sandler predict that, with a voucher attached, the Food and Drug Administration could make an approval decision on Akebia's drug in the middle of 2021. 11. Akebia Therapeutics Inc. Akebia and Vifor Pharma announce exclusive license agreement to provide vadadustat to Fresenius Medical Care in the U.S. upon FDA Approval [media release]. The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease. Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT). CAMBRIDGE, Mass.—February 25, 2021– Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, … As Akebia and its Japanese pharmaceutical partner, Otsuka, intend to make their pitch to the FDA by the end of this year, investors will want to keep tabs on the progress of the application before taking the plunge. Hypoxia-inducible factors in the kidney. The use of this website constitutes acceptance of our user agreement.

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