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Albireo (ALBO) Up on Results From Alagille Syndrome Study
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Albireo Pharma stock increased 14.41% on Oct 11 after the company announced positive top-line results from a phase III ASSERT study evaluating the safety and efficacy of Bylvay in Alagille syndrome (ALGS) patients from birth to early adulthood.
Shares of Albireo have returned 0.6% in the year-to-date period against the industry’s decline of 27.5%.
Image Source: Zacks Investment Research
The late-stage ASSERT study met its primary and key secondary endpoint.
In the study, Bylvay demonstrated a statistically significant reduction in pruritus from baseline at the sixth month, as measured by the PRUCISION Observer-Reported Outcome scratching score compared with a placebo, which was the study’s primary endpoint.
The study also demonstrated a significant reduction in serum bile acid levels from baseline in the Bylvay, throughout the study, in comparison to the placebo arm.
The study displayed statistically significant improvements in multiple sleep parameters, starting as early as week one to four, which continued through the study period of six months. No severe adverse events were observed, except for a low incidence of drug-related diarrhea.
Alagille syndrome is a rare inherited multi-system disorder characterized by liver damage, affecting young children. Liver damage is caused by the paucity of the bile duct, which prevents the bile flow from the liver to the small intestine. Per the company, the disease affects 25,000 people worldwide, where almost 95% of the affected people suffer from chronic cholestasis and approximately 88% show symptoms of severe intractable pruritus.
Bylvay is a once-daily non-systemic ileal bile acid transport inhibitor (IBATi) and is already approved in the United States and in the European Union for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) above three years of age.
The company intends to submit regulatory filings both in the United States and the European Union immediately.
Bylvay is also being evaluated in another phase III BOLD study to treat biliary atresia, another rare, life-threatening disease affecting children. Albireo continues to enroll patients in the BOLD study and is currently on track to complete the process by the end of 2022. It intends to report top-line data from the BOLD study in 2024.
Acadia’s loss per share estimates for 2022 have narrowed from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has narrowed from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same in the remaining two occasions. The average negative earnings surprise for STSA is 6.83%.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.
Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the reaming occasion. The average earnings surprise for IMCR is 33.28%.
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Albireo (ALBO) Up on Results From Alagille Syndrome Study
Albireo Pharma stock increased 14.41% on Oct 11 after the company announced positive top-line results from a phase III ASSERT study evaluating the safety and efficacy of Bylvay in Alagille syndrome (ALGS) patients from birth to early adulthood.
Shares of Albireo have returned 0.6% in the year-to-date period against the industry’s decline of 27.5%.
Image Source: Zacks Investment Research
The late-stage ASSERT study met its primary and key secondary endpoint.
In the study, Bylvay demonstrated a statistically significant reduction in pruritus from baseline at the sixth month, as measured by the PRUCISION Observer-Reported Outcome scratching score compared with a placebo, which was the study’s primary endpoint.
The study also demonstrated a significant reduction in serum bile acid levels from baseline in the Bylvay, throughout the study, in comparison to the placebo arm.
The study displayed statistically significant improvements in multiple sleep parameters, starting as early as week one to four, which continued through the study period of six months. No severe adverse events were observed, except for a low incidence of drug-related diarrhea.
Alagille syndrome is a rare inherited multi-system disorder characterized by liver damage, affecting young children. Liver damage is caused by the paucity of the bile duct, which prevents the bile flow from the liver to the small intestine. Per the company, the disease affects 25,000 people worldwide, where almost 95% of the affected people suffer from chronic cholestasis and approximately 88% show symptoms of severe intractable pruritus.
Bylvay is a once-daily non-systemic ileal bile acid transport inhibitor (IBATi) and is already approved in the United States and in the European Union for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) above three years of age.
The company intends to submit regulatory filings both in the United States and the European Union immediately.
Bylvay is also being evaluated in another phase III BOLD study to treat biliary atresia, another rare, life-threatening disease affecting children. Albireo continues to enroll patients in the BOLD study and is currently on track to complete the process by the end of 2022. It intends to report top-line data from the BOLD study in 2024.
Albireo Pharma Price
Albireo Pharma price | Albireo Pharma Quote
Zacks Rank and Stocks to Consider
Albireo currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Acadia Pharmaceuticals (ACAD - Free Report) , Aridis Pharmaceuticals (ARDS - Free Report) , and Immunocore (IMCR - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acadia’s loss per share estimates for 2022 have narrowed from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has narrowed from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same in the remaining two occasions. The average negative earnings surprise for STSA is 6.83%.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.
Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the reaming occasion. The average earnings surprise for IMCR is 33.28%.