Albireo Pharma, Inc. (ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Looking back to 2 days ago, Albireo Pharma Inc (ALBO) priced a 4,000,000 share secondary stock offering at $40.00 per share. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. 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. 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. 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 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) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … Find the latest press releases from Albireo Pharma, Inc. Common Stock (ALBO) at Nasdaq.com. A high-level overview of Albireo Pharma, Inc. (ALBO) stock. Press release content from Globe Newswire. 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. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. 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. “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. 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. 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. 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 Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4). 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. BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. 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. 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 Pharma stock price target cut to $60 from $69 at Wedbush Mar. 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. About Albireo Who We Are. The Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. 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. Other symptoms include jaundice, poor weight gain and slowed growth. 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. 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. 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). © 2020 GlobeNewswire, Inc. All Rights Reserved. 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. 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. The Company expects to complete IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth and no approved pharmacological therapies. BOSTON, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … Company profile page for Albireo Pharma Inc including stock price, company news, press releases, executives, board members, and contact information Albireo cautions you not to place undue reliance on any forward-looking statement. Albireo was spun out from AstraZeneca in 2008. BOSTON, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … 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. Equal Opportunity Employer. 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. 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. ET by Tomi Kilgore Albireo Pharma stock price target cut to $32 from $36 at Ladenburg Thalmann Detailed price information for Albireo Pharma Inc (ALBO-Q) from The Globe and Mail including charting and trades. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. “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.”. 3, 2020 at 7:39 a.m. 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. Syndrome, biliary atresia options that include partial external biliary diversion ( PEBD ) and liver transplantation across studies... 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