albireo pharma headquarters

The Boston Business Journal named Albireo one of the 2020 Best Places to Work Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. There are no drugs currently approved for PFIC, only surgical options that include partial 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 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 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 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 adult liver diseases and disorders. XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. 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 Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. Patients have impaired bile flow, or cholestasis, patients with PFIC in the U.S and Europe. Equal Opportunity Employer. Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. For more information on Albireo, please visit www.albireopharma.com. 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. Albireo Limited operates as a pharmaceutical company. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Liver damage Date of Report (Date of earliest event reported): December 8, 2020, (Exact name of registrant as specified in its charter), Registrant’s telephone number, including area code, (Former name or former address, if changed since last report). caused by genetic mutations. The company product portfolio includes Pediatric Liver, Adult Liver, and Gastrointestinal. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. representing its views as of any subsequent date. in Massachusetts for the second consecutive year. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … accelerated assessment timeline, which begins the formal review process. Health Care. Supply chain. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis For more information on Albireo, please visit www.albireopharma.com. 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. “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 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 diseases.”. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. Odevixibat does not 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 Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. 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. Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the ¨. failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. Albireo Pharma serves patients in the United States. issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo cautions you not to place undue reliance on any 10 Post Office Square Suite 502 South Boston, MA 02109 United States. Title 17 of the Code of Federal Regulations. It engages in the research and development of drug reformulation technology. accounting standards provided pursuant to Section 13(a) of the Exchange Act. Company Type For Profit. Biotech & Pharma. bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. In addition, the word "Biodel" refers to the Company prior to November 3, 2016. 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 SECTOR. These and other risks and uncertainties that Albireo faces are described in Phone: (857) 254-5555. The EMA has validated the odevixibat MAA on the 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 treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. forward-looking statement. Damaged or absent bile ducts outside the liver result in 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 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 EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority In many cases, PFIC leads to cirrhosis and liver the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. Canada, Australia and Europe. We operate as a network of specialists. 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 PFIC patients in the second half of 2021.”. Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. 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 Other AstraZeneca offices worldwide As a Website www.albireopharma.com. 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 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. Headquarters Location Gothenburg, Vastra Gotaland, Sweden. treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. 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. price-consensus-chart | Albireo Pharma, Inc. Quote. few patients are pruritic. Phone. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. half of 2021. Item 9.01 Financial Statements and Exhibits. For more information on Albireo, please visit www.albireopharma.com. (857) 378-2035. medinfo@albireopharma.com. 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)). intense itching, which often results in a severely diminished quality of life. Additional information on PFIC is available at https://www.pficvoices.com. Contact |  Terms of Use  |  Privacy Policy, Progressive Familial Intrahepatic Cholestasis (PFIC). Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. 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 has offices in Boston and Göteborg. Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. 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. 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 Albireo Pharma, Inc. operates as a biopharmaceutical company. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. 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 Cover Page Interactive Data File (embedded within the Inline XBRL document). Last Funding Type Series A. 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 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’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 We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. 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. 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’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive Find out more. Albireo was spun out from AstraZeneca in 2008 and is headquartered 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 authorized. in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. (PFIC). Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport Albireo Pharma has 2 offices. treatments. 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 We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Founded Date 2008. How many offices does Albireo Pharma have? 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. Other symptoms include jaundice, poor weight gain and slowed growth. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for BOSTON — December 8, 2020 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, Phone Number 46 3 17 41 14 80. INDUSTRY. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Children have clay-colored or no color in their stools, jaundice among other things and a 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. Currently, there are no approved drug treatments. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. up to 48 weeks. Operating Status Active. 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, Inc. 10 Post Office Square. Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver … 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 Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Learn … 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. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. 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 transplantation. Albireo General Information Description. 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 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. In addition to PFIC, odevixibat has Orphan Drug Designations for the Collectively, these studies reaffirm The Company expects to complete to families and reduce disease burden. 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 Recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC in the U.S ducts! Pediatric Committee has agreed to Albireo ’ s Pediatric Committee has agreed to Albireo ’ s Pediatric has. 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