Odevixibat does not 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. The resulting bile build-up in liver cells causes liver disease and symptoms. These and other risks and uncertainties that Albireo faces are described in 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. With U.S. and EU 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 half of 2021. Odevixibat is a … - 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 -. About Biliary Atresia. The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. © 2020 GlobeNewswire, Inc. All Rights Reserved. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Stay up to date on the latest stock price, chart, news, analysis, fundamentals, trading and investment tools. Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … 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 is developing novel bile acid modulators to treat rare pediatric and adult liver diseases. The AP news staff was not involved in its creation. An Albireo Pharma news release notes that the company saw positive results from its recent Phase 3 clinical trial of odevixibat. 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. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. Albireo Announces Two Financing Transactions to Extend Cash Runway Into the B.. Albireo to Present at 2020 Jefferies Virtual Healthcare Conference, Albireo Reports Q1 2020 Financial Results and Provides Business Update, Albireo to Report First Quarter 2020 Financial Results on May 7, Albireo to Present at 19th Annual Needham Healthcare Conference, Albireo Completes Enrollment in Phase 2 Study of Elobixibat in NASH/NAFLD. Albireo Pharma, Inc. (ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 Upcoming event on ALBIREO PHARMA, INC. 11/17/20: Q3 2020 Earnings Release (Projected) Company calendar Other symptoms include jaundice, poor weight gain and slowed growth. The most prominent and problematic ongoing manifestation of the disease is pruritus, or intense itching, which often results in a severely diminished quality of life. Albireo was spun out from AstraZeneca in 2008. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. 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. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. 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 treatments. 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). Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the first three months of life, and up to 88 percent also present with severe, intractable pruritus. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Albireo Announces Proposed Public Offering of 3,000,000 Shares of Common Stoc.. Albireo Phase 3 Trial Meets Both Primary Endpoints for Odevixibat in PFIC. 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. Company profile page for Albireo Pharma Inc including stock price, company news, press releases, executives, board members, and contact information The PEDFIC 1 trial evaluated odevixibat 40 µg/kg/day or 120 µg/kg/day or placebo in 62 patients, ages 6 months to 15.9 years. 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. 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 … Albireo Pharma (NASDAQ:ALBO): Q3 GAAP EPS of -$1.96 misses by $0.45.Revenue of $2.13M (+53.2% Y/Y) beats by $0.5M.Press Release We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and 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 PFIC patients in the second half of 2021.”. 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. Forward-Looking Statements. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth and no approved pharmacological therapies. About Albireo Who We Are. Albireo Pharma, Inc. (NASDAQ: ALBO) Q4 2018 Earnings Conference Call ... Albireo issued a press release highlighting recent business accomplishments and … Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. 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. Media Contact:Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com, Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. 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. Equal Opportunity Employer. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. 3, 2020 at 7:39 a.m. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. And investment tools and adult liver disease and Orphan Drug Designations in albireo pharma press release small intestine treat rare and... 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