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. 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. 30, 2019 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … 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. 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 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 Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4). Upcoming event on ALBIREO PHARMA, INC. 11/17/20: Q3 2020 Earnings Release (Projected) Company calendar “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.”. Currently, there are no approved drug treatments. 3, 2020 at 7:39 a.m. Detailed price information for Albireo Pharma Inc (ALBO-Q) from The Globe and Mail including charting and trades. 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. “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. Stay up to date on the latest stock price, chart, news, analysis, fundamentals, trading and investment tools. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope to families and reduce disease burden. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. 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. ALBIREO PHARMA, INC. : Press releases relating to ALBIREO PHARMA, INC. Investor relations | Nasdaq: ALBO | Nasdaq 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. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. About Albireo Who We Are. 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 … 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. 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. 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. About Biliary Atresia. Looking back to 2 days ago, Albireo Pharma Inc (ALBO) priced a 4,000,000 share secondary stock offering at $40.00 per share. 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. 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. 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. 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. Other symptoms include jaundice, poor weight gain and slowed growth. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. The resulting bile build-up in liver cells causes liver disease and symptoms. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … 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. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. The Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. 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. The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. Find the latest press releases from Albireo Pharma, Inc. Common Stock (ALBO) at Nasdaq.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. - 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 -. © 2020 GlobeNewswire, Inc. All Rights Reserved. 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. BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with 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, 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. 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). 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. About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. 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. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. 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. 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 … Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. 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. 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. Odevixibat is a … Albireo cautions you not to place undue reliance on any forward-looking statement. 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 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. 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. Forward-Looking Statements. 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. Equal Opportunity Employer. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. BOSTON, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth and no approved pharmacological therapies. Albireo was spun out from AstraZeneca in 2008. 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). Albireo is developing novel bile acid modulators to treat rare pediatric and adult liver diseases. Initiation of a pivotal Phase 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. 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. 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. An Albireo Pharma news release notes that the company saw positive results from its recent Phase 3 clinical trial of odevixibat. “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. 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. 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. 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.”. 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. 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 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 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. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Albireo cautions you not to place undue reliance on any forward-looking statement. Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) Albireo Pharma, Inc. December 11, 2020 GMT. 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. Children have clay-colored or no color in their stools, jaundice among other things and a few patients are pruritic. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Additional information on PFIC is available at https://www.pficvoices.com. ET by Tomi Kilgore Albireo Pharma stock price target cut to $32 from $36 at Ladenburg Thalmann 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. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 Albireo Pharma, Inc. (ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. The Company expects to complete IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. Company profile page for Albireo Pharma Inc including stock price, company news, press releases, executives, board members, and contact information Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. 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 Pharma, Inc. (NASDAQ: ALBO) Q4 2018 Earnings Conference Call ... Albireo issued a press release highlighting recent business accomplishments and … For more information on Albireo, please visit www.albireopharma.com. Albireo Pharma stock price target cut to $60 from $69 at Wedbush Mar. 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. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The AP news staff was not involved in its creation. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for patients with PFIC in the U.S and Europe. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. A high-level overview of Albireo Pharma, Inc. (ALBO) stock. 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