albireo pharma headquarters

REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. 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 seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). (PFIC), biliary atresia and Alagille syndrome. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Albireo Pharma, Inc. 10 Post Office Square. These and other risks and uncertainties that Albireo faces are described in Media Contact: Supply chain. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Suite 1000. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. The In many cases, PFIC leads to cirrhosis and liver 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 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. 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. Cover Page Interactive Data File (embedded within the Inline XBRL document). Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com, Lisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com, Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177, 0001322505 false 0001322505 2020-12-08 2020-12-08 iso4217:USD xbrli:shares iso4217:USD xbrli:shares. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis Albireo provides pharmaceutical products and services. 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. operates as a biopharmaceutical company. forward-looking statement. “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 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 was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Item 9.01 Financial Statements and Exhibits. 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. transplantation. The Company researches and develops drugs. 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 Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. In addition, the word "Biodel" refers to the Company prior to November 3, 2016. The Company expects to complete Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive 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). 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 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, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Albireo Pharma serves patients in the United States. INDUSTRY. Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. The company product portfolio includes Pediatric Liver, Adult Liver, and Gastrointestinal. result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. to families and reduce disease burden. Collectively, these studies reaffirm As a 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/ 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 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. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. 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. up to 48 weeks. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. Simon has an MBA from the University of Virginia’s Darden School of Business. The resulting bile build-up in liver cells causes liver disease and symptoms. 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) Albireo Pharma Inc is a development-stage pharmaceutical company. similar expressions to identify forward-looking statements. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. adult liver diseases and disorders. Title 17 of the Code of Federal Regulations. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. 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. Liver damage 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 This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. For more information on Albireo, please visit www.albireopharma.com. 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 With U.S. and EU A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Initiation of a pivotal Phase Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Equal Opportunity Employer. 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 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)). Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority 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. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and Albireo Limited operates as a pharmaceutical company. Headquarters Location Gothenburg, Vastra Gotaland, Sweden. 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 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. “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 Founded Date 2008. 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 MEdicines (PRIME) scheme for the treatment of PFIC. Health Care. accelerated assessment timeline, which begins the formal review process. first three months of life, and up to 88 percent also present with severe, intractable pruritus. Other symptoms include jaundice, poor weight gain and slowed growth. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a caused by genetic mutations. 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 Albireo cautions you not to place undue reliance on any The most prominent and problematic ongoing manifestation of the disease is pruritus, or Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Additional information on PFIC is available at https://www.pficvoices.com. treatments. 1-857-254-5555. Patients have impaired bile flow, or cholestasis, BOSTON — December 8, 2020 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Last Funding Type Series A. It engages in the research and development of drug reformulation technology. 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 How many offices does Albireo Pharma have? Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. 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). diseases.”. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., 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 There are no drugs currently approved for PFIC, only surgical options that include partial XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. Medical Information. We operate as a network of specialists. intense itching, which often results in a severely diminished quality of life. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Children have clay-colored or no color in their stools, jaundice among other things and a external biliary diversion (PEBD) and liver transplantation. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for 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. authorized. Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. 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 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. Address. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. JOIN ALBIREO. The Company focuses on the development and commercialization of novel bile acid modulators … Currently, there are no approved drug treatments. PFIC patients in the second half of 2021.”. 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 10 Post Office Square Suite 502 South Boston, MA 02109 United States. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. half of 2021. Operating Status Active. Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. SECTOR. Full results from PEDFIC 1, the first and largest, global, Phase Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. 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. Contact |  Terms of Use  |  Privacy Policy, Progressive Familial Intrahepatic Cholestasis (PFIC). View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. 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 to PFIC, odevixibat has Orphan Drug Designations for 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 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 Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Boston, MA 02109. the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. 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 … 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. Where are Albireo Pharma offices? Find out more. Forward-looking statements include 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 Biotech & Pharma. accounting standards provided pursuant to Section 13(a) of the Exchange Act. Albireo was spun out from AstraZeneca in 2008 and is headquartered Odevixibat does not Who We Are. WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. Canada, Australia and Europe. Other AstraZeneca offices worldwide 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 Albireo serves customers in the United Kingdom. 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 Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. Additionally, long-term data from PEDFIC 2, an Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. The EMA has validated the odevixibat MAA on the Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. 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 Phone: (857) 254-5555. patients with PFIC in the U.S and Europe. 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 Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. ¨. Albireo Pharma has offices in Boston and Göteborg. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. (PFIC). We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. few patients are pruritic. 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 IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. Damaged or absent bile ducts outside the liver result in (857) 378-2035. medinfo@albireopharma.com. Company Type For Profit. Albireo often uses words Albireo General Information Description. Albireo Pharma, Inc. Price and Consensus. representing its views as of any subsequent date. 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 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 Website www.albireopharma.com. 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. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Phone. For more information on Albireo, please visit www.albireopharma.com. Website The Boston Business Journal named Albireo one of the 2020 Best Places to Work Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK. failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. For more information on Albireo, please visit www.albireopharma.com. Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver … 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 -. in Massachusetts for the second consecutive year. Learn … Phone Number 46 3 17 41 14 80. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope

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