With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for Website 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 We operate as a network of specialists. 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. Boston, MA 02109. IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. authorized. XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. Albireo General Information Description. The Company researches and develops drugs. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. “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 Albireo Pharma serves patients in the United States. treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. Phone. seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). 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., formerly Biodel Inc., is a specialty biopharmaceutical company. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. Albireo Pharma, Inc. operates as a biopharmaceutical company. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. The “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. 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 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 Currently, there are no approved drug treatments. Albireo cautions you not to place undue reliance on any WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. 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 Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Damaged or absent bile ducts outside the liver result in Albireo was spun out from AstraZeneca in 2008 and is headquartered The most prominent and problematic ongoing manifestation of the disease is pruritus, or The resulting bile build-up in liver cells causes liver disease and symptoms. to families and reduce disease burden. SECTOR. Address. Albireo Pharma Inc is a development-stage pharmaceutical company. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. 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 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. 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 This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Albireo Pharma, Inc. Price and Consensus. 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 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. 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. Supply chain. We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. 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). The Boston Business Journal named Albireo one of the 2020 Best Places to Work 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 up to 48 weeks. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis Collectively, these studies reaffirm 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. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. PFIC patients in the second half of 2021.”. 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 The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Children have clay-colored or no color in their stools, jaundice among other things and a Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. 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 -. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. 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. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. 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) Albireo Pharma has 2 offices. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport The Company focuses on the development and commercialization of novel bile acid modulators … 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. Albireo Pharma has offices in Boston and Göteborg. 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 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 Who We Are. 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. forward-looking statement. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. In addition to PFIC, odevixibat has Orphan Drug Designations for the Albireo Pharma, Inc. 10 Post Office Square. result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … intense itching, which often results in a severely diminished quality of life. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. 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 Full results from PEDFIC 1, the first and largest, global, Phase It engages in the research and development of drug reformulation technology. 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. Other symptoms include jaundice, poor weight gain and slowed growth. (PFIC). With U.S. and EU similar expressions to identify forward-looking statements. 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. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. 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) For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. Where are Albireo Pharma offices? Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. 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. treatments. inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. 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 A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The EMA has validated the odevixibat MAA on the 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)). We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. 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 The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. 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 Other AstraZeneca offices worldwide 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 Odevixibat does not caused by genetic mutations. As a 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. failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the 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 Canada, Australia and Europe. Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the adult liver diseases and disorders. Founded Date 2008. 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