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Albireo (ALBO) Cholestasis Drug Bylvay Gets European Approval
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Albireo Pharma, Inc. announced that the European Commission has approved its cholestasis drug, Bylvay (odevixibat) for treating progressive familial intrahepatic cholestasis (PFIC).
Per the press release, the drug is the first and only once-daily drug approved for treating all subtypes of PFIC, globally. PFIC is a rare and devastating disorder affecting young children. The disease causes progressive, life-threatening liver disease, which may progress to cirrhosis and liver failure within the first 10 years of life.
The European approval was based on data from two late-stage studies — PEDFIC 1 and PEDFIC 2 — that evaluated the drug in PFIC patients. Data from the PEDFIC 1 study demonstrated that odevixibat reduced serum bile acid responses (sBAs) and improved pruritus assessments with a single-digit diarrhea rate. Interim data from the open-label PEDFIC 2 study showed that treatment with Bylvay sustained reductions in serum bile acid as well as improvements in pruritus assessments up to 48 weeks. The treatment with the drug also improved other markers of liver function in patients.
Albireo is planning to commercialize Bylvay in Europe independently. The commercial launch of the drug is expected in September, starting with the largest EU market potential, Germany.
A regulatory application seeking approval for the drug in the United States is under review. The FDA is expected to provide its decision on Jul 20.
So far this year, shares of Albireo have lost 4.1% compared with the industry’s decrease of 3.1%.
Image Source: Zacks Investment Research
Meanwhile, the company continues to develop the drug in other rare pediatric cholestatic diseases. A phase III study — BOLD — is evaluating the drug in biliary atresia. Another late-stage study, ASSERT, is evaluating it in patients with Alagille syndrome. Top-line data from the BOLD and ASSERT studies are anticipated in 2024 and 2022, respectively.
Codexis’ loss per share estimates have narrowed from 55 cents to 50 cents for 2021 and from 54 cents to 50 cents for 2022 in the past 30 days. The company delivered an earnings surprise of 44.34%, on average, in the last four quarters.
Bicycle Therapeutics’ loss per share estimates have improved from $3.18 to $2.79 for 2021 and from $3.63 to $3.29 for 2022 in the past 30 days. The stock has risen 92.2% so far this year.
Arcutis’ loss per share estimates have narrowed from $4.76 to $4.41 for 2021 and from $5.16 to $4.67 in the past 30 days. The company delivered an earnings surprise of 2.46%, on average, in the last four quarters. The stock has surged 102.1% so far this year.
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Albireo (ALBO) Cholestasis Drug Bylvay Gets European Approval
Albireo Pharma, Inc. announced that the European Commission has approved its cholestasis drug, Bylvay (odevixibat) for treating progressive familial intrahepatic cholestasis (PFIC).
Per the press release, the drug is the first and only once-daily drug approved for treating all subtypes of PFIC, globally. PFIC is a rare and devastating disorder affecting young children. The disease causes progressive, life-threatening liver disease, which may progress to cirrhosis and liver failure within the first 10 years of life.
The European approval was based on data from two late-stage studies — PEDFIC 1 and PEDFIC 2 — that evaluated the drug in PFIC patients. Data from the PEDFIC 1 study demonstrated that odevixibat reduced serum bile acid responses (sBAs) and improved pruritus assessments with a single-digit diarrhea rate. Interim data from the open-label PEDFIC 2 study showed that treatment with Bylvay sustained reductions in serum bile acid as well as improvements in pruritus assessments up to 48 weeks. The treatment with the drug also improved other markers of liver function in patients.
Albireo is planning to commercialize Bylvay in Europe independently. The commercial launch of the drug is expected in September, starting with the largest EU market potential, Germany.
A regulatory application seeking approval for the drug in the United States is under review. The FDA is expected to provide its decision on Jul 20.
So far this year, shares of Albireo have lost 4.1% compared with the industry’s decrease of 3.1%.
Image Source: Zacks Investment Research
Meanwhile, the company continues to develop the drug in other rare pediatric cholestatic diseases. A phase III study — BOLD — is evaluating the drug in biliary atresia. Another late-stage study, ASSERT, is evaluating it in patients with Alagille syndrome. Top-line data from the BOLD and ASSERT studies are anticipated in 2024 and 2022, respectively.
ALBIREO PHARMA Price
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Zacks Rank & Stocks to Consider
Albireo currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector include Codexis (CDXS - Free Report) , Bicycle Therapeutics (BCYC - Free Report) and Arcutis Biotherapeutics (ARQT - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Codexis’ loss per share estimates have narrowed from 55 cents to 50 cents for 2021 and from 54 cents to 50 cents for 2022 in the past 30 days. The company delivered an earnings surprise of 44.34%, on average, in the last four quarters.
Bicycle Therapeutics’ loss per share estimates have improved from $3.18 to $2.79 for 2021 and from $3.63 to $3.29 for 2022 in the past 30 days. The stock has risen 92.2% so far this year.
Arcutis’ loss per share estimates have narrowed from $4.76 to $4.41 for 2021 and from $5.16 to $4.67 in the past 30 days. The company delivered an earnings surprise of 2.46%, on average, in the last four quarters. The stock has surged 102.1% so far this year.