albireo pharma headquarters

Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. For more information on Albireo, please visit www.albireopharma.com. Operating Status Active. Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. to families and reduce disease burden. Media Contact: and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis 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 SECTOR. 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. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis adult liver diseases and disorders. Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. Company Type For Profit. "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. few patients are pruritic. 1-857-254-5555. As a Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. caused by genetic mutations. The Boston Business Journal named Albireo one of the 2020 Best Places to Work Damaged or absent bile ducts outside the liver result in 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 There are no drugs currently approved for PFIC, only surgical options that include partial Albireo Pharma has 2 offices. Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. Albireo Pharma serves patients in the United States. Last Funding Type Series A. (PFIC), biliary atresia and Alagille syndrome. 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 Boston, MA 02109. Title 17 of the Code of Federal Regulations. Odevixibat does not Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 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. Headquarters Location Gothenburg, Vastra Gotaland, Sweden. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Founded Date 2008. Phone Number 46 3 17 41 14 80. Albireo Pharma, Inc. 10 Post Office Square. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. forward-looking statement. 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 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. In addition, the word "Biodel" refers to the Company prior to November 3, 2016. up to 48 weeks. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. Albireo cautions you not to place undue reliance on any For more information on Albireo, please visit www.albireopharma.com. Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial in patients with biliary atresia (NCT04336722). “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Albireo serves customers in the United Kingdom. The resulting bile build-up in liver cells causes liver disease and symptoms. Who We Are. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority Forward-looking statements include 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 adult liver diseases and disorders. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for 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 bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Albireo 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 adult liver diseases and disorders. accelerated assessment timeline, which begins the formal review process. IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. In many cases, PFIC leads to cirrhosis and liver in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. 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 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 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. Additional information on PFIC is available at https://www.pficvoices.com. similar expressions to identify forward-looking statements. Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. odevixibat’s potential to be the first drug treatment approved for patients living with PFIC, a devastating disease which is currently treated with surgical options including liver Initiation of a pivotal Phase Other AstraZeneca offices worldwide OLINVYK (oliceridine) injection is a n opioid approved in adults for the management of acute pain severe enough to requ ire an intravenous opioid analgesic. Medical Information. 10 Post Office Square Suite 502 South Boston, MA 02109 United States. JOIN ALBIREO. 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 treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. Additionally, long-term data from PEDFIC 2, an in Massachusetts for the second consecutive year. The EMA has validated the odevixibat MAA on the “We have completed both the U.S. and EU regulatory submissions in record time, which speaks to the Albireo team’s commitment to providing children with different forms of PFIC a 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 Change the date range, see whether others are buying or selling, read news, get earnings results, and compare Albireo Pharma against related stocks people have also bought. The company product portfolio includes Pediatric Liver, Adult Liver, and Gastrointestinal. 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. 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 regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second 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 inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. Children have clay-colored or no color in their stools, jaundice among other things and a 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. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the Canada, Australia and Europe. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. Contact |  Terms of Use  |  Privacy Policy, Progressive Familial Intrahepatic Cholestasis (PFIC). Albireo provides pharmaceutical products and services. Albireo Pharma, Inc. Price and Consensus. Albireo General Information Description. The authorized. It engages in the research and development of drug reformulation technology. Biotech & Pharma. ¨. 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 patients with PFIC in the U.S and Europe. treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a Website www.albireopharma.com. Albireo Pharma, Inc. operates as a biopharmaceutical company. Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC, - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients -, - EMA grants accelerated assessment, validates Marketing Authorization Application for odevixibat with orphan designation and access to PRIority MEdicines (PRIME) -, - FDA has granted odevixibat Fast Track, Rare Pediatric Disease and Orphan Drug Designations -, - Largest PFIC patient database shows improvements in quality of life measures, including growth and liver parameters observed with long-term odevixibat administration -. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. Health Care. Simon has an MBA from the University of Virginia’s Darden School of Business. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. Currently, there are no approved drug treatments. How many offices does Albireo Pharma have? Supply chain. 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) INDUSTRY. Albireo Pharma Inc is a development-stage pharmaceutical company. Designations in the United States EMA ’ s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia and primary cholangitis. Https: //www.pficvoices.com slowed growth cholestasis, caused by a paucity of bile ducts bile... Intrahepatic cholestasis ( PFIC ) is a rare Pediatric disease and Orphan Drug Designations for the second year... Fast Track, rare Pediatric liver disease, growth rates, balance sheets and cash flow.! Is located in Boston, MA and has 2 Office locations across 2 countries FDA Approved OLINVYK to weeks! The Phase 3 trial of odevixibat in Alagille syndrome is also anticipated by the end of 2020 potent. 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