Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive 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 Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) Albireo Pharma, Inc. December 11, 2020 GMT. 3, 2020 at 7:39 a.m. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Initiation of a pivotal Phase 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. About Biliary Atresia. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Additionally, long-term data from PEDFIC 2, an 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 up to 48 weeks. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. Equal Opportunity Employer. Albireo is developing novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Other symptoms include jaundice, poor weight gain and slowed growth. Find the latest press releases from Albireo Pharma, Inc. Common Stock (ALBO) at Nasdaq.com. Collectively, these studies reaffirm 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 transplantation. 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. 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). Full results from PEDFIC 1, the first and largest, global, Phase 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. Albireo to Announce Topline Results from PEDFIC 1 Phase 3 Trial of Odevixibat.. Albireo Reports Topline Results from Phase 2 Trial of Elobixibat in NAFLD/NAS.. Albireo Reports Q2 2020 Financial Results and Provides Business Update, Albireo to Present at the William Blair Biotech Focus Conference 2020, Albireo to Report Q2 2020 Financial Results on August 6. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Boston, USA-based biotech Albireo Pharma has submitted a New Drug Application (NDA) to the US Food and… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. Forward-Looking Statements. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. ... any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release … BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it … Children have clay-colored or no color in their stools, jaundice among other things and a few patients are pruritic. Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome Read the full press release Click here to find out why we have been named a Best Place to Work in Boston for 2 … About Alagille SyndromeAlagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. Stay up to date on the latest stock price, chart, news, analysis, fundamentals, trading and investment tools. “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 treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth and no approved pharmacological therapies. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. BOSTON , Oct. 02, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the grant of inducement stock options exercisable for an aggregate of 23,000 shares of Albireo’s common. The Company expects to complete IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. BOSTON, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … About OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. 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 representing its views as of any subsequent date. Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4). - 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 -. 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. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. Looking back to 2 days ago, Albireo Pharma Inc (ALBO) priced a 4,000,000 share secondary stock offering at $40.00 per share. “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 treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. An Albireo Pharma news release notes that the company saw positive results from its recent Phase 3 clinical trial of odevixibat. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Albireo Reports Fourth Quarter and Year-End 2019 Financial Results, and Provi.. Albireo Recognizes Rare Disease Day and Supports Global Effort to “Refr.. Albireo to Present at Cowen and Company 40th Annual Health Care Conference. Company profile page for Albireo Pharma Inc including stock price, company news, press releases, executives, board members, and contact information Albireo Pharma, Inc. (NASDAQ: ALBO) Q4 2018 Earnings Conference Call ... Albireo issued a press release highlighting recent business accomplishments and … BOSTON, Oct. 05, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, joins the PFIC Advocacy and Resource Network (PFIC Network) in recognition of PFIC Awareness Day 2020, a global effort to support patients and families affected by progressive familial intrahepatic cholestasis … About Albireo Who We Are. Positive results from the trial were announced on September 8, 2020: News Release – Albireo Phase 3 Trial Meets Both Primary Endpoints for Odevixibat in PFIC. 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