Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a 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 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 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 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 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 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 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 the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. About AlbireoAlbireo 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 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. Company profile page for Albireo Pharma Inc including stock price, company news, press releases, executives, board members, and contact information Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. 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). We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) BOSTON, Dec. 11, 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 18,500 shares of Albireo’s common stock. Albireo was spun out from AstraZeneca in 2008. Upcoming event on ALBIREO PHARMA, INC. 11/17/20: Q3 2020 Earnings Release (Projected) Company calendar 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. 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 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. The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. 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 … Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4). Other symptoms include jaundice, poor weight gain and slowed growth. Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixiba.. New Phase 3 Data at AASLD Show Durable Response to Odevixibat in a Rare Pedia.. Albireo to Participate in Jefferies and Piper Sandler Virtual Investor Confer.. Albireo Reports Q3 2020 Financial Results and Provides Business Update, Albireo's Odevixibat PFIC Phase 3 Results Accepted for AASLD Late-Breakers, Albireo Announces Presentations at NASPGHAN 2020 Annual Meeting, Albireo Recognizes PFIC Awareness Day 2020, Albireo Prices Public Offering of 4,000,000 Shares of Common Stock. Forward-Looking Statements. Detailed price information for Albireo Pharma Inc (ALBO-Q) from The Globe and Mail including charting and trades. The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. 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. Forward-looking statements include 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 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 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 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 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 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 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 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 issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. For more information on Albireo, please visit www.albireopharma.com. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. 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. 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. Equal Opportunity Employer. “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. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The Company expects to complete IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. ET by Tomi Kilgore Albireo Pharma stock price target cut to $32 from $36 at Ladenburg Thalmann 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. BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … 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. Albireo to Report Fourth Quarter and Year-End 2019 Financial Results on March.. Albireo Announces Closing of $46 Million Public Offering Including Exercise i.. Albireo Announces Proposed Public Offering of Common Stock. About Biliary Atresia. 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 … 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo Pharma, Inc. (ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … 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 diseases.”. 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 … Additional information on PFIC is available at https://www.pficvoices.com. 3, 2020 at 7:39 a.m. 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. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. Press release content from Globe Newswire. 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 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. Albireo cautions you not to place undue reliance on any forward-looking statement. Albireo Pharma stock price target cut to $60 from $69 at Wedbush Mar. Albireo Launches Expanded Access Program for Odevixibat for Patients in the U.. Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Bili.. Albireo to Host Key Opinion Leader Call on Clinical Outcome Assessments. © 2020 GlobeNewswire, Inc. All Rights Reserved. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. 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. 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. The AP news staff was not involved in its creation. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope to families and reduce disease burden. About Albireo Who We Are. Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. 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. Products described on this Website, with the exception of elobixibat for chronic constipation in Japan, are investigational new drugs, and are not approved for use or commercially available. 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