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Albireo Down on Unimpressive Data From Mid-Stage NASH Study
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Albireo Pharma, Inc. discontinued development of its partnered drug, Goofice (elobixibat), as a potential treatment for nonalcoholic fatty liver disease (“NAFLD”) and nonalcoholic steatohepatitis (“NASH”). The company was developing the drug in a phase II proof-of-concept study. The company decided to discontinue development as elobixibat failed to achieve proof-of-concept for key NASH measures. However, the phase II study met the primary endpoint of reduction of low-density lipoprotein cholesterol (LDL-C) levels from baseline. Patients who received elobixibat achieved clinically meaningful reduction of 20.5 mg/dL in serum LDL-C from baseline compared to 11.1 mg/dL reduction for placebo.
Please note that Goofice is marketed in Japan in collaboration with partner EA Pharma for the treatment of chronic constipation.
Shares of Albireo were down 3% in after-market trading on Aug 18, following the announcement. However, the company’s shares were up 6.2% so far this year compared with the industry’s rise of 3.9%.
Meanwhile, Albireo is focused on developing its most advanced pipeline candidate, odevixibat. The company is developing the candidate in two separate pivotal, phase III studies — PEDFIC 1 and BOLD — as a potential treatment for liver diseases — for progressive familial intrahepatic cholestasis (“PFIC”) and biliary atresia, respectively.
Albireo remains on track to report top-line data from PEDFIC 1 study soon. The company plans to launch the candidate in PFIC indication in the second half of 2021. Albireo is enrolling patients in the BOLD study. The company is planning to initiate a pivotal, phase III study to evaluate the candidate in patients Alagille syndrome — a genetic disorder that can affect the liver, heart, and other parts of the body — by the end of 2020.
The company also has an early-stage candidate and a partnered candidate in its pipeline, which are being developed for pediatric liver disease and bile acid malabsorption, respectively.
Emergent Biosolutions’ earnings per share estimates have moved up from $3.58 to $5.60 for 2020 in the past 30 days. The company delivered an earnings surprise of 127.41%, on average, in the last four quarters. The stock has risen 140.8% so far this year.
Repligen’s earnings per share estimates have moved up from $1.13 to $1.25 for 2020 in the past 30 days. The company delivered an earnings surprise of 34.14%, on average, in the last four quarters. The stock has risen 59.2% so far this year.
Horizon Therapeutics’ earnings per share estimates have increased from $1.81 to $2.87 for 2020 in the past 30 days. The company delivered an earnings surprise of 38.63%, on average, in the last four quarters. The stock has surged 102.1% so far this year.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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Albireo Down on Unimpressive Data From Mid-Stage NASH Study
Albireo Pharma, Inc. discontinued development of its partnered drug, Goofice (elobixibat), as a potential treatment for nonalcoholic fatty liver disease (“NAFLD”) and nonalcoholic steatohepatitis (“NASH”). The company was developing the drug in a phase II proof-of-concept study. The company decided to discontinue development as elobixibat failed to achieve proof-of-concept for key NASH measures. However, the phase II study met the primary endpoint of reduction of low-density lipoprotein cholesterol (LDL-C) levels from baseline. Patients who received elobixibat achieved clinically meaningful reduction of 20.5 mg/dL in serum LDL-C from baseline compared to 11.1 mg/dL reduction for placebo.
Please note that Goofice is marketed in Japan in collaboration with partner EA Pharma for the treatment of chronic constipation.
Shares of Albireo were down 3% in after-market trading on Aug 18, following the announcement. However, the company’s shares were up 6.2% so far this year compared with the industry’s rise of 3.9%.
Meanwhile, Albireo is focused on developing its most advanced pipeline candidate, odevixibat. The company is developing the candidate in two separate pivotal, phase III studies — PEDFIC 1 and BOLD — as a potential treatment for liver diseases — for progressive familial intrahepatic cholestasis (“PFIC”) and biliary atresia, respectively.
Albireo remains on track to report top-line data from PEDFIC 1 study soon. The company plans to launch the candidate in PFIC indication in the second half of 2021. Albireo is enrolling patients in the BOLD study. The company is planning to initiate a pivotal, phase III study to evaluate the candidate in patients Alagille syndrome — a genetic disorder that can affect the liver, heart, and other parts of the body — by the end of 2020.
The company also has an early-stage candidate and a partnered candidate in its pipeline, which are being developed for pediatric liver disease and bile acid malabsorption, respectively.
Albireo Pharma, Inc. Price
Albireo Pharma, Inc. price | Albireo Pharma, Inc. Quote
Zacks Rank & Stocks to Consider
Albireo currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks from the biotech sector include Emergent Biosolutions Inc. (EBS - Free Report) , Repligen Corporation (RGEN - Free Report) and Horizon Therapeutics , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent Biosolutions’ earnings per share estimates have moved up from $3.58 to $5.60 for 2020 in the past 30 days. The company delivered an earnings surprise of 127.41%, on average, in the last four quarters. The stock has risen 140.8% so far this year.
Repligen’s earnings per share estimates have moved up from $1.13 to $1.25 for 2020 in the past 30 days. The company delivered an earnings surprise of 34.14%, on average, in the last four quarters. The stock has risen 59.2% so far this year.
Horizon Therapeutics’ earnings per share estimates have increased from $1.81 to $2.87 for 2020 in the past 30 days. The company delivered an earnings surprise of 38.63%, on average, in the last four quarters. The stock has surged 102.1% so far this year.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>