For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a For more information on Albireo, please visit www.albireopharma.com. 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. 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 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 Collectively, these studies reaffirm patients with PFIC in the U.S and Europe. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Damaged or absent bile ducts outside the liver result in accelerated assessment timeline, which begins the formal review process. These and other risks and uncertainties that Albireo faces are described in Phone: (857) 254-5555. Find out more. Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. Liver damage Cover Page Interactive Data File (embedded within the Inline XBRL document). The resulting bile build-up in liver cells causes liver disease and symptoms. in Massachusetts for the second consecutive year. The Company expects to complete Albireo Pharma, Inc. operates as a biopharmaceutical company. On December 8, 2020, Albireo Pharma, Inc. issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) Title 17 of the Code of Federal Regulations. 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). SECTOR. Full results from PEDFIC 1, the first and largest, global, Phase 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. 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 -. The Company focuses on the development and commercialization of novel bile acid modulators … 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. WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. 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. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis 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 has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. 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/ in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for Boston, MA 02109. Albireo Pharma, Inc. 10 Post Office Square. In addition, the word "Biodel" refers to the Company prior to November 3, 2016. REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. INDUSTRY. Other symptoms include jaundice, poor weight gain and slowed growth. 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 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. few patients are pruritic. external biliary diversion (PEBD) and liver transplantation. Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. 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 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. Forward-looking statements include the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. Albireo General Information Description. Address. Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. caused by genetic mutations. 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. (PFIC). We operate as a network of specialists. (PFIC), biliary atresia and Alagille syndrome. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. Additionally, long-term data from PEDFIC 2, an JOIN ALBIREO. Currently, there are no approved drug treatments. (857) 378-2035. medinfo@albireopharma.com. treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. 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 first three months of life, and up to 88 percent also present with severe, intractable pruritus. 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 Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. 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)). The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority As a Website intense itching, which often results in a severely diminished quality of life. 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, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. The EMA has validated the odevixibat MAA on the similar expressions to identify forward-looking statements. 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 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. forward-looking statement. adult liver diseases and disorders. Health Care. Medical Information. treatments. 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. The Company researches and develops drugs. Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the representing its views as of any subsequent date. such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and Phone. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope The most prominent and problematic ongoing manifestation of the disease is pruritus, or 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 result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport Who We Are. 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 to families and reduce disease burden. Patients have impaired bile flow, or cholestasis, Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Additional information on PFIC is available at https://www.pficvoices.com. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Website www.albireopharma.com. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. 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 Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. 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 "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. Other AstraZeneca offices worldwide Simon was most recently SVP and Chief Financial Officer at PAREXEL International Corporation, a leading global clinical research organization, where he led the financial aspects of the transition from public to private-equity owned company. Albireo often uses words 10 Post Office Square Suite 502 South Boston, MA 02109 United States. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. 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 Children have clay-colored or no color in their stools, jaundice among other things and a treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. 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 ¨. Where are Albireo Pharma offices? Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. For more information on Albireo, please visit www.albireopharma.com. 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