ALBO Albireo Pharma Inc.

25.46
-0.34  -1%
Previous Close 25.8
Open 25.53
52 Week Low 20.3
52 Week High 43.4099
Market Cap $490,834,022
Shares 19,278,634
Float 14,355,432
Enterprise Value $238,151,021
Volume 167,056
Av. Daily Volume 193,623
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Upcoming Catalysts

Drug Stage Catalyst Date
BYLVAY (odevixibat) - (ASSERT)
Alagille syndrome
Phase 3
Phase 3
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BYLVAY (odevixibat) - (BOLD)
Biliary atresia
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
A3907
Liver disease
Phase 1
Phase 1
Phase 1 top-line data reported that the trial achieved it primary and secondary endpoints, noted December 16, 2021. Phase 2 trial planned for 2022.
BYLVAY (odevixibat)
Progressive familial intrahepatic cholestasis (PFIC)
Approved
Approved
FDA approval announced July 20, 2021.
Elobixibat
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 trial met primary endpoint. However, development in NASH will not continue - August 18, 2020.

Latest News

  1. – Bylvay net sales guidance revised to $6-7M vs. expectations of $3-4M

    – Unaudited cash of at least $248M, updates guidance with cash into 2024

    – BOLD Phase 3 study in biliary atresia is over 50% enrolled

    – ASSERT Phase 3 study in Alagille syndrome on track for topline data by end of year

    BOSTON, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, updated guidance for Bylvay net sales, cash and the two Phase 3 clinical studies. Global Bylvay net sales in 2021 are expected to be $6-7 million, higher than previous guidance of $3-4 million. Unaudited cash and cash equivalents as of December 31, 2021 was at least $248 million, and the Company expects to have…

    – Bylvay net sales guidance revised to $6-7M vs. expectations of $3-4M

    – Unaudited cash of at least $248M, updates guidance with cash into 2024

    – BOLD Phase 3 study in biliary atresia is over 50% enrolled

    – ASSERT Phase 3 study in Alagille syndrome on track for topline data by end of year

    BOSTON, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, updated guidance for Bylvay net sales, cash and the two Phase 3 clinical studies. Global Bylvay net sales in 2021 are expected to be $6-7 million, higher than previous guidance of $3-4 million. Unaudited cash and cash equivalents as of December 31, 2021 was at least $248 million, and the Company expects to have sufficient cash into 2024 based on current revenue and expense projections. Albireo has two ongoing Phase 3 studies which are progressing according to plan, with the BOLD study in biliary atresia passing the 50% enrollment milestone and the ASSERT study on track for topline data by the end of 2022.

    "Bylvay launch uptake has been faster than anticipated and has significantly exceeded our internal expectations," said Ron Cooper, President and Chief Executive Officer of Albireo. "At the same time, our cash position is strong, and we are pleased that our two Phase 3 studies are enrolling as planned and look forward to additional data in 2022."

    The Company has unaudited cash and cash equivalents of at least $248 million as of December 31, 2021 versus $262.6 million as of September 30, 2021, providing the Company with sufficient capital resources to fund the continued launch of Bylvay and advancement of its development programs as planned.

    Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) which was recently approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC, and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. The Company continues to enroll and dose patients in the Phase 3 ASSERT study, a pivotal trial of Bylvay in patients with Alagille syndrome, and remains on track for topline data by the end of 2022. Biliary atresia is the most common pediatric cholestatic liver disease with no approved drug treatment. The Phase 3 BOLD study, which is the first and only pivotal trial of an IBATi in biliary atresia, has passed the 50% enrollment milestone and remains on track for topline data in 2024.

    The early development pipeline continues to advance. A3907, the first oral systemic ASBT inhibitor, is expected to enter Phase 2 for adult liver diseases and A2342, the first oral NTCP inhibitor being developed for hepatitis B and D, will begin first in human studies this year.

    The Company's management will participate in the H.C. Wainwright Virtual BioConnect 2022 Conference to be held January 10-13, 2022. The presentation will be available beginning January 10, 2022 on the Investors page of the company website at https://ir.albireopharma.com/ and archived for replay two weeks following the event. The Company starts the year with a strong financial and commercial position based on the following milestones achieved in 2021:

    The Company also congratulates Dr. Roger A. Jeffs on his appointment as Chief Executive Officer of Liquidia Corporation as of January 3, 2022. With this new leadership role, Dr. Jeffs will leave the Albireo Board of Directors to focus on his new business obligations. Dr. Jeffs joined the Board in 2017 and has seen the Company through growth and development of the pipeline as well as the global commercialization of Bylvay.

    "Over the last five years, Roger has been a dedicated member of our Board and his contributions have been invaluable as we achieved major milestones, including global commercialization of our first product and exceeding our product revenue forecast in the first quarter of sales. We thank Roger for his contributions over his tenure and wish him luck in his new role," added Cooper.

    About Albireo

    Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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 Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; 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 Bylvay in PFIC, the BOLD and ASSERT trials, Phase 2 trial for A3907 and the IND-enabling studies for A2342; or the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions to identify forward-looking statements. 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: whether favorable findings from clinical trials of Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company's clinical trials; and the Company's critical accounting policies. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 disclaims any obligation to update any forward-looking statement except as required by applicable law.

    Media Contact:

    Colleen Alabiso, 857-356-3905, 

    Investor Contact:

    Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578



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  2. – First oral, systemic ASBT inhibitor was safe and well tolerated

    – Secondary and exploratory objectives show favorable pharmacokinetics and systemic exposure, while providing target engagement signals

    – Company on track to initiate planned adult liver disease Phase 2 study in 2022

    BOSTON, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor. The study achieved both primary and secondary objectives. Phase 1 study is a first-in-human, double-blind, single and multiple ascending dose study…

    – First oral, systemic ASBT inhibitor was safe and well tolerated

    – Secondary and exploratory objectives show favorable pharmacokinetics and systemic exposure, while providing target engagement signals

    – Company on track to initiate planned adult liver disease Phase 2 study in 2022

    BOSTON, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor. The study achieved both primary and secondary objectives. Phase 1 study is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics of orally administered A3907. A3907 was safe and well tolerated in this study at systemic exposures that demonstrated therapeutic benefits in preclinical models. With the potential to inhibit ileal, renal and hepatic ASBT, A3907 could provide the optimal balance of efficacy and tolerability in patients in multiple liver diseases.

    The study met its primary objectives with data showing A3907 overall to be safe and well tolerated, with no serious adverse events (SAEs) or discontinuations due to treatment emergent adverse events (TEAEs). All TEAEs were mild, the most common were mainly abdominal symptoms such as loose stools, and all participants finished the trial protocol. No clinically significant effects in clinical chemistry, hematology, physical examinations or ECG. The study also met its secondary objectives with dose-related plasma exposure up to 81 mg dose, with no accumulation. Exposure levels were within the range that show effects in animal disease models. Single doses of A3907 showed dose proportional increases in plasma exposure up to 81 mg with no further increase at a dose of 162 mg. The study showed target engagement with 7alpha-hydroxy-4-cholesten-3-one (C4) increases and low-density lipoprotein cholesterol (LDL-C) reductions, with C4 increases indicating elevation in bile acid excretion, while LDL-C reduction indicating elevated synthesis of bile acids from cholesterol.

    "The results from our Phase 1 study of A3907 show that the drug candidate is safe and well tolerated with favorable pharmacokinetics and high systemic exposure, giving us the greenlight to advance to a Phase 2 study," said Jan Mattsson, Chief Scientific Officer of Albireo. "These results represent an exciting milestone in the development of this next generation bile acid modulators as we could potentially be offering physicians new treatments to treat liver diseases that could increase efficacy without sacrificing tolerability for patients."

    The Phase 1 trial was a randomized, double-blind, placebo-controlled, single and seven day multiple-dose study was conducted in 54 and 22, respectively, healthy subjects. Doses evaluated were 1-162 mg in the single ascending dose portion, and 9-67.5 mg in the multiple ascending dose portion. Primary objectives were safety and tolerability, secondary objectives were evaluation of pharmacokinetics, and there were multiple exploratory endpoints.

    About A3907

    A3907 is the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor with high oral bioavailability that has potential to inhibit intestinal and renal bile acid reuptake as well as ASBT expressed by cholangiocytes. Due to high oral bioavailability, A3907 can inhibit ASBT in the intestine and kidney, with the potential to increase elimination of bile acids by both fecal and urinary excretion. By using dual pathway diversion of bile acids, next generation modulators like A3907 seek to increase efficacy without the dose limiting diarrhea seen with bile acid transport inhibitors today. A3907 is being developed for adult cholestatic liver diseases such as primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).

    The completed Phase 1 study of A3907 is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an A3907 oral formulation. In pre-clinical studies, A3907 showed high systemic exposure and increased level of urinary bile acid secretion in mice, and in a mice model of cholestasis and sclerosing cholangitis, A3907 decreased serum bile acids, and reduced plasma levels of transaminases as well as markers for cell damage and fibrosis.

    About Cholestatic Adult Liver Diseases

    Adult cholestatic diseases are a diverse group of disorders known for the appearance of jaundice, fatigue, pruritus and/or complications of cirrhosis. The most common adult cholestatic liver diseases are primary biliary cholangitis and primary sclerosing cholangitis. Primary biliary cholangitis is a chronic disease in which the bile ducts in the liver are slowly destroyed. When the bile ducts are damaged, bile can back up in the liver and sometimes lead to irreversible scarring of liver tissue (cirrhosis). Primary sclerosing cholangitis is a disease of the bile ducts where inflammation causes scars within the bile ducts. These scars make the ducts hard and narrow, gradually causing serious liver damage that leads to liver failure, repeated infections and tumors of the bile duct or liver.

    About Albireo

    Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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 Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; 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 Bylvay in PFIC, the BOLD and ASSERT trials, Phase 1 trial for A3907 and the IND-enabling studies for A2342; potential regulatory approval by and discussions with the FDA or EMA regarding our programs; or the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions to identify forward-looking statements. 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: whether favorable findings from clinical trials of Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company's clinical trials; and the Company's critical accounting policies. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 disclaims any obligation to update any forward-looking statement except as required by applicable law.

    Media Contact:

    Colleen Alabiso, 857-356-3905, 

    Investor Contact:

    Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578



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  3. – Data show significant correlations in serum bile acid reductions and long-term improvements in pruritus and sleep

    – Reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid and/or rifampicin use and Bylvay treatment

    – Improvements in serum bile acids, pruritus, quality of life, and sleep observed in some children with prior partial external biliary diversion surgery

    – Considerable impact on quality of life of patients and their caregivers

    BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, will be presenting five posters on Bylvay (odevixibat) at the North American Society for Pediatric Gastroenterology…

    – Data show significant correlations in serum bile acid reductions and long-term improvements in pruritus and sleep

    – Reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid and/or rifampicin use and Bylvay treatment

    – Improvements in serum bile acids, pruritus, quality of life, and sleep observed in some children with prior partial external biliary diversion surgery

    – Considerable impact on quality of life of patients and their caregivers

    BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, will be presenting five posters on Bylvay (odevixibat) at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) meeting being held December 12–18. Data will be presented that show evidence of correlations in serum bile acid reductions and long-term improvements in pruritus and sleep in patients with progressive familial intrahepatic cholestasis (PFIC); reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid (UDCA) and/or rifampicin use; and the efficacy and safety of Bylvay in patients with PFIC and prior partial external biliary diversion (PEBD). Data on disease burden and natural history of PFIC will be presented to describe the clinical characteristics of the disease. There will also be a poster presentation on the Phase 3 double-blind, randomized, placebo-controlled ASSERT study of Bylvay in Alagille syndrome (ALGS). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older.

    "We are pleased to present additional data supporting Bylvay's potential to reduce disease burden and improve the standard of care in the treatment of pruritus in PFIC," said Jan Mattsson, Chief Scientific Officer at Albireo. "As we continue to see sustained correlations between the reduction of serum bile acids and long-term improvements in pruritus and quality of life measures, as well as certain results from the use of Bylvay with post-PEBD patients, we are encouraged that data could demonstrate Bylvay's impact on disease modification over time."

    Bylvay PEDFIC 1 & 2 Treatment Data

    PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study.

    Poster of Distinction

    Poster #69: Relationships Between Decreases in Serum Bile Acids, Pruritus, and Sleep Disturbance Scores With Up to 72 Weeks of Odevixibat Treatment in Patients With Progressive Familial Intrahepatic Cholestasis

    Poster Session I: Monday, December 13, 1:30-2:15pm ET

    • Significant correlations were observed between reductions in sBAs and reductions in pruritus and most sleep disturbance scores.
    • Percentage change in sBAs from baseline to weeks 49−72 was significantly correlated with change in pruritus scores during that interval (r=0.58; P<0.001).
    • Moderate correlations were also observed between percentage change in sBAs from baseline to weeks 49−72 and changes during that interval in caregiver-reported percentage of days where patients had bleeding associated with scratching, needed soothing or help falling asleep, and were sleeping with caregivers.
    • No serious drug-related treatment emergent adverse events (TEAEs) or deaths occurred. The overall incidence of any event of diarrhea was 21% and all instances were mild to moderate in severity and resolved, most without intervention.

    Poster of Distinction

    Poster #78: Efficacy and Safety of Odevixibat Therapy With Concomitant UDCA or Rifampicin in Children With Progressive Familial Intrahepatic Cholestasis: Data From the PEDFIC 1 and PEDFIC 2 Trials

    Poster Session I: Monday, December 13, 1:30-2:15pm ET

    • Patients with PFIC receiving Bylvay treatment experienced reductions in sBAs and improvements in pruritus with and without concomitant ursodeoxycholic acid (UDCA) and/or rifampicin use.
    • After 48 weeks of Bylvay treatment, percentages of patients meeting criteria for sBA response were similar among patients using vs not using UDCA and/or rifampicin (using vs not using, each 67%)
      • 74% and 40% in patients using vs not using UDCA, respectively.
      • 54% and 82% in patients using vs not using rifampicin.
    • Mean proportions of positive pruritus assessments (PPAs) were similar in patients using vs not using UDCA (65% vs 72%, respectively) and in patients using vs not using UDCA and/or rifampicin (66% vs 69%); mean proportions of PPAs in patients using vs not using rifampicin (56% and 81%).
    • Safety and tolerability were comparable in patients using vs not using UDCA and/or rifampicin with Bylvay. Incidence of TEAEs was similar in patients using vs not using UDCA and/or rifampicin (78% vs 90%, respectively), as well as in patients using vs not using UDCA (77% vs 87%) and rifampicin (75% vs 86%).

    Poster #303: Efficacy And Safety Of Odevixibat In Children With Progressive Familial Intrahepatic Cholestasis With Prior Partial External Biliary Diversion

    Poster Session II: Wednesday, December 15, 1:30-2:15pm ET

    • Improvements were observed in sBA levels, pruritus, quality of life (QoL), and sleep parameters in some patients who had prior partial external biliary diversion, or PEBD surgery. Improvements were observed despite elevated sBAs and pruritus in these patients at baseline, suggesting that some patients with poor response to PEBD could potentially respond to Bylvay treatment.
    • All of the 10 patients with prior PEBD had elevated sBAs and pruritus scores prior to the first dose of Bylvay, indicating that prior PEBD surgery was unsuccessful or only partially successful.
      • 7 patients had reductions in pruritus score and 4 met criteria for pruritus response (i.e., ≥1-point drop in pruritus score).
      • 5 patients had reductions in sBA levels; 1 patient, who also met pruritus response criteria, met criteria for sBA response (i.e., sBAs reduced by ≥70% or levels ≤70 μmol/L) at last assessment.
      • Of the 9 patients with post-baseline QoL assessments, 6 had improved observer-reported PedsQL total scores, including all 4 pruritus and/or sBAs responders.
      • Pruritus and/or sBA responders also had reductions from baseline to last assessment in percentage of days with bleeding associated with scratching, needing soothing or help falling asleep, and sleeping with caregivers.
    • TEAEs, including mild abdominal pain, were observed in the subgroup of patients with prior PEBD; all TEAEs were mild to moderate in severity, and no patients discontinued due to a TEAE.

    Poster #292: Disease Burden and Natural History of Progressive Familial Intrahepatic Cholestasis: Baseline Clinical Characteristics Among Odevixibat-Treated Patients in the Phase 3 PEDFIC Studies

    Poster Session II: Wednesday, December 15, 1:30-2:15pm ET

    • Baseline characteristics of the patient population studied reflect the broader population of patients with PFIC; specifically this is a pediatric population with cholestasis, impaired hepatic function, growth deficits, and impacted sleep parameters; and PFIC had a considerable impact on the QoL of patients and their caregivers.
    • The complexity of PFIC was illustrated by the heterogeneity and severity of the clinical signs and symptoms in these patients with different types of PFIC.

    Bylvay in ASSERT Study

    Poster #281: The ASSERT Study: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat In Patients With Alagille Syndrome

    Poster Session II: Wednesday, December 15, 1:30-2:15pm ET

    • ASSERT is an on-going, global Phase 3 pivotal trial designed to evaluate the safety and efficacy of Bylvay for 24 weeks in relieving pruritus in patients with Alagille syndrome.
    • ASSERT is expected to enroll approximately 63 patients, including approximately 45 patients aged <18 years and an additional exploratory cohort of up to 18 patients aged ≥18 years. 

    Full scientific abstracts are available and can be viewed here: Journal of Pediatric Gastroenterology and Nutrition.

    About Bylvay (odevixibat)

    Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). The European Commission (EC) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. Bylvay is available for sale in Germany and will be available for sale in other European countries following pricing and reimbursement approval. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The medicine can only be obtained with a prescription. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit www.bylvay.com.

    In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT Phase 3 study for Alagille syndrome.

    About Albireo

    Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo's commercialization plans and expectations for commercializing Bylvay in the U.S. and Europe; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; 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 Bylvay in PFIC, the BOLD and ASSERT trials, Phase 1 trial for A3907 and the IND-enabling studies for A2342; potential regulatory approval by and discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of Bylvay of the treatment of PFIC patients and its potential to improve the current standard of care; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions to identify forward-looking statements. 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: results achieved in Bylvay in the treatment of patients with PFIC may be different than observed in clinical trials, and may vary among patients; whether favorable findings from clinical trials of Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other products candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; 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 Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company's clinical trials; and the Company's critical accounting policies. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 disclaims any obligation to update any forward-looking statement except as required by applicable law.

    Media Contact:

    Colleen Alabiso, 857-356-3905, 

    Investor Contact:

    Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578



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  4. BOSTON, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the upcoming departure of Pat Horn, M.D., Ph.D., Chief Medical Officer, who will be leaving at the end of the year after almost three and a half years with the Company. Jan Mattsson, Ph.D., Chief Scientific Officer and co-founder of Albireo, will be taking over as the interim head of R&D, leading research and development of early and late-stage assets and programs. As one of the co-founders of the Company with deep experience in drug development and approvals, Dr. Mattsson is primed to lead the R&D organization with his institutional knowledge, vision for the pipeline and products…

    BOSTON, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the upcoming departure of Pat Horn, M.D., Ph.D., Chief Medical Officer, who will be leaving at the end of the year after almost three and a half years with the Company. Jan Mattsson, Ph.D., Chief Scientific Officer and co-founder of Albireo, will be taking over as the interim head of R&D, leading research and development of early and late-stage assets and programs. As one of the co-founders of the Company with deep experience in drug development and approvals, Dr. Mattsson is primed to lead the R&D organization with his institutional knowledge, vision for the pipeline and products, and ability to deliver against corporate objectives.

    "Our company has made significant progress, going from a small clinical stage team to a fully integrated commercial organization with the launch of BylvayTM (odevixibat), while pursuing two additional Bylvay indications and advancing two promising, novel early assets. Over the last three years, Pat has been an important leader as we progressed our development programs and brought our first product to market. I thank him for his guidance and contributions in providing hope for the families we serve," said Ron Cooper, President and Chief Executive Officer of Albireo.

    Over his time with the Company, Dr. Horn completed the PEDFIC 1 Phase 3 study and the ongoing open-label extension PEDFIC 2 study, both of which contributed to the large body of positive evidence supporting U.S. and European approvals and the subsequent launch of Bylvay. Simultaneously, Dr. Horn and his team initiated two Phase 3 pivotal studies with ASSERT (Alagille syndrome) and BOLD (biliary atresia), both of which are the largest gold standard trials, which will help pave the way toward the Company's aspiration to reach $1 billion dollars of Bylvay sales by the end of the decade. Dr. Horn also partnered with Dr. Mattsson and his team in progressing the Company's earlier stage assets A3907 and A2342 for adult cholestatic liver diseases and Hepatitis B & D, respectively.

    About Albireo

    Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company is progressing a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo's commercialization plans and expectations for commercializing Bylvay in the U.S. and Europe; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; 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 Bylvay in PFIC, the BOLD and ASSERT trials, Phase 1 trial for A3907 and the IND-enabling studies for A2342; potential regulatory approval by and discussions with the FDA or EMA regarding our programs; expectations that the Company's distribution and supply agreements will drive availability of Bylvay in key markets globally, and potential revenue that may be generated by such agreements; potential regulatory approval and plans for potential commercialization of Bylvay in countries outside of the U.S. and Europe, including Japan; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of Bylvay of the treatment of PFIC patients and its potential to improve the current standard of care; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions to identify forward-looking statements. 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: there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC may be different than observed in clinical trials, and may vary among patients; other potential 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 Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other products candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; 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 Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company's clinical trials; and the Company's critical accounting policies. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 disclaims any obligation to update any forward-looking statement except as required by applicable law.

    Media Contact: Colleen Alabiso, 857-356-3905,

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177



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  5. BOSTON, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the appointment of Constantine Chinoporos as Chief Business Officer and a member of the Albireo Enterprise Leadership Team. Mr. Chinoporos was most recently at Boston Pharmaceuticals where he was the Chief Business Officer responsible for all business development, new product planning operations and in-licensing of 20 programs over his tenure. He brings 30 years of experience in business development, new product planning operations, corporate development, global licensing and divestitures. In this new role, Mr. Chinoporos will be responsible for creating a forward integration strategy…

    BOSTON, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the appointment of Constantine Chinoporos as Chief Business Officer and a member of the Albireo Enterprise Leadership Team. Mr. Chinoporos was most recently at Boston Pharmaceuticals where he was the Chief Business Officer responsible for all business development, new product planning operations and in-licensing of 20 programs over his tenure. He brings 30 years of experience in business development, new product planning operations, corporate development, global licensing and divestitures. In this new role, Mr. Chinoporos will be responsible for creating a forward integration strategy to accelerate Albireo's growth and maximize the value of our opportunities.

    "With recent approvals and a global launch of Bylvay, as well as the continued progression of our pipeline assets, we have a strong foundation with multiple opportunities. Constantine's deep strategic and partnering expertise in the biopharmaceutical arena is an invaluable addition as we develop a forward integration strategy that drives growth and value for Albireo," said Ron Cooper, President and Chief Executive Officer of Albireo.

    In the last decade, Mr. Chinoporos also held senior strategic roles at Sanofi, Genzyme and Eli Lilly. Most recently at Boston Pharmaceuticals, he led all business development and new product planning functions. Over six years, Mr. Chinoporos in-licensed 20 programs, which included a novel collaboration structure with GlaxoSmithKline. Prior to that, Mr. Chinoporos served in various corporate and business development leadership roles leading global teams for 14 years at Sanofi and Genzyme, and completing notable transactions. Before Genzyme, Mr. Chinoporos served in various capacities at Eli Lilly, including roles in corporate finance & investment banking and alliance management.

    "I am excited to be joining Albireo at this pivotal time when Bylvay is now globally available with the potential to become a billion-dollar product by the end of the decade, while at the same time, there is also great opportunity with earlier stage products that could serve the large adult and viral disease markets," said Constantine Chinoporos, Chief Business Officer of Albireo. "The corporate value of the company with a globally commercialized drug, a strategic pipeline where partnership opportunities exist, and a talented global team, sets Albireo up to realize the strategic business plans through the decade and I'm thrilled to be a part of it."

    Mr. Chinoporos will receive inducement grants of stock options exercisable for an aggregate of 23,000 shares of Albireo's common stock and restricted stock units representing the opportunity to acquire 5,000 shares of Albireo's common stock. The exercise price for the inducement grants will be $22.98, the closing price of Albireo's common stock as of December 1, 2021, and were granted as inducements material to Mr. Chinoporos' acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement grants have a 10-year term and vest over a four-year period, subject to Mr. Chinoporos' continued service with Albireo through the applicable vesting dates. The vesting schedule for the inducement grants is 25 percent on the one-year anniversary of Mr. Chinoporos' start date with Albireo and 75 percent in 12 equal quarterly installments thereafter. The inducement grants are subject to the terms and conditions of Albireo's 2020 Inducement Equity Incentive Plan.

    About Albireo

    Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company is progressing a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo's commercialization plans and expectations for commercializing Bylvay in the U.S. and Europe; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; 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 Bylvay in PFIC, the BOLD and ASSERT trials, Phase 1 trial for A3907 and the IND-enabling studies for A2342; potential regulatory approval by and discussions with the FDA or EMA regarding our programs; expectations that the Company's distribution and supply agreements will drive availability of Bylvay in key markets globally, and potential revenue that may be generated by such agreements; potential regulatory approval and plans for potential commercialization of Bylvay in countries outside of the U.S. and Europe, including Japan; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of Bylvay of the treatment of PFIC patients and its potential to improve the current standard of care; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions to identify forward-looking statements. 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: there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC may be different than observed in clinical trials, and may vary among patients; other potential 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 Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other products candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; 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 Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company's clinical trials; and the Company's critical accounting policies. 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. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 disclaims any obligation to update any forward-looking statement except as required by applicable law.                   

    Media Contact:

    Colleen Alabiso, 857-356-3905,

    Investor Contact:

    Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177



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