Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … For more information on Albireo, please visit www.albireopharma.com. Beyond PFIC, we are poised to initiate our Phase 3 trial in Alagille syndrome by end of year, expanding our pivotal programs across three rare liver The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Previously, Simon spent 8 years at GlaxoSmithKline plc based in their global headquarters outside London culminating in his role as SVP Finance, Global Pharmaceuticals with responsibility for the finance function of the global pharmaceutical business. Children have clay-colored or no color in their stools, jaundice among other things and a “With strong data from the first and largest global Phase 3 study ever conducted in PFIC, we have a comprehensive database that has the potential to influence the way PFIC is greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. familial intrahepatic cholestasis (PFIC) and biliary atresia, and the first site initiation for the Phase 3 trial in Alagille syndrome is planned for this month. BOSTON — December 8, 2020 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) (857) 378-2035. medinfo@albireopharma.com. These and other risks and uncertainties that Albireo faces are described in external biliary diversion (PEBD) and liver transplantation. of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a JOIN ALBIREO. Address. The Boston Business Journal named Albireo one of the 2020 Best Places to Work statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of accounting standards provided pursuant to Section 13(a) of the Exchange Act. For more information on Albireo, please visit www.albireopharma.com. the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. first three months of life, and up to 88 percent also present with severe, intractable pruritus. Albireo Pharma Inc is a development-stage pharmaceutical company. Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. Earlier in his career, he spent 20 years at Eli Lilly and Company in numerous senior leadership roles in the U.S. and Europe including Head of Investor Relations, European CFO and as Corporate Controller. Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. Albireo Pharma has 2 offices. In many cases, PFIC leads to cirrhosis and liver Supply chain. It is focused on the development and commercialization of bile acid modulators to treat orphan pediatric liver diseases and gastrointestinal (GI), disorders where improper flow or absorption of bile causes serious medical conditions for which there is unmet need. authorized. Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425), Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12), Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)), Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). in Massachusetts for the second consecutive year. Albireo Pharma, Inc. operates as a biopharmaceutical company. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport Other AstraZeneca offices worldwide potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential There are no drugs currently approved for PFIC, only surgical options that include partial The Company focuses on the development and commercialization of novel bile acid modulators … EU, accelerated assessment and access to the PRIME scheme in the EU and Fast Track designation in the U.S., we’re on track for potential approval, launch and broad global access to odevixibat for Currently, there are no approved drug treatments. bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. transplantation. inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. PFIC patients in the second half of 2021.”. 1-857-254-5555. Canada, Australia and Europe. treatments. It engages in the research and development of drug reformulation technology. Collectively, these studies reaffirm trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Cover Page Interactive Data File (embedded within the Inline XBRL document). If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial Suite 1000. Simon Harford joined Albireo in October 2018 as Chief Financial Officer following many years of finance experience in the pharmaceutical and healthcare industry both in the U.S and internationally. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal Find out more. Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. few patients are pruritic. Headquarters Location Gothenburg, Vastra Gotaland, Sweden. Phone: (857) 254-5555. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. adult liver diseases and disorders. Albireo serves customers in the United Kingdom. We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the planned pivotal trial for odevixibat in require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our intense itching, which often results in a severely diminished quality of life. half of 2021. the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. In fact, over the past month, current quarter estimates have narrowed from a loss of $1.39 per share to a loss of $1.36 per share, while current year estimates have narrowed from a loss of $7.13 per share to a loss of $6.96 per share. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Additional information on PFIC is available at https://www.pficvoices.com. SECTOR. specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for Liver damage The most prominent and problematic ongoing manifestation of the disease is pruritus, or Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Company Type For Profit. Media Contact: Boston, MA 02109. Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Albireo Pharma Inc 10 Post Office Square, Suite 502 South BOSTON 02109 United States USA; Phone +1 (857) 415-4774; Fax +1 (302) 636-5454; Website http://www.albireopharma.com/ Initiation of a pivotal Phase Founded Date 2008. Item 9.01 Financial Statements and Exhibits. initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, and Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other As a The Company expects to complete Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. patients with PFIC in the U.S and Europe. Learn … Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments and encouraging markers of liver and growth function in patients treated 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. Full results from PEDFIC 1, the first and largest, global, Phase With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for accelerated assessment timeline, which begins the formal review process. Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly How many offices does Albireo Pharma have? forward-looking statement. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Alagille syndrome; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or Operating subsidiary is located in Boston, Massachusetts, and treatment-emergent adverse events TEAEs. Inc. Quote Company offers biotechnology services with a wide range of liver diseases bile. 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