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Ultragenyx (RARE) Begins Dosing in Pivotal Study on Setrusumab
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Ultragenyx Pharmaceutical Inc. (RARE - Free Report) announced that it has dosed the first patient in a pivotal phase II/III study evaluating its fully human monoclonal antibody, setrusumab (UX143), for the treatment of osteogenesis imperfecta (“OI”) in patients aged between five to less than 26 years.
The pivotal Orbit study is a seamless phase II/III study investigating setrusumab for the treatment of OI in children and adults with OI sub-types I, III and IV.
The Orbit study will investigate the effect of setrusumab on fracture rate in patients aged five to less than 26 years with OI sub-types I, III, and IV as compared to placebo.
Shares of Ultragenyx have lost 6.4% so far this year compared with the industry’s decline of 14.9%.
Image Source: Zacks Investment Research
Setrusumab is being developed as part of Ultragenyx’s collaboration and license agreement with UK-based biopharmaceutical company, MereoBioPharma Group plc (MREO - Free Report) .
Ultragenyx entered into a collaboration and license agreement with Mereo for the development of setrusumabin December 2020.
Per the agreement, Ultragenyx will lead global development of setrusumab and commercialize the product in the United States, Turkey and rest of the world, excluding the European Economic Area, United Kingdom and Switzerland, where MREO retains the commercial rights.
Ultragenyx is planning to evaluate setrusumab in other studies.
The company plans to begin a phase III study evaluating setrusumab versus bisphosphonates in patients aged between two to less than five years for the treatment of OI over a period of 12 to 24 months in the second half of 2022.
Ultragenyx is also looking to continue with the study of setrusumab for treating OI in adult patients aged more than 25 years.
The FDA and the European Medicines Agency have granted orphan drug designation to setrusumab for the treatment of OI.
The Zacks Consensus Estimate for Aligos Therapeutics’ loss per share has narrowed 14.3% for 2022 and 43.7% for 2023 over the past 60 days.
Earnings of ALGS surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 272.3% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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Ultragenyx (RARE) Begins Dosing in Pivotal Study on Setrusumab
Ultragenyx Pharmaceutical Inc. (RARE - Free Report) announced that it has dosed the first patient in a pivotal phase II/III study evaluating its fully human monoclonal antibody, setrusumab (UX143), for the treatment of osteogenesis imperfecta (“OI”) in patients aged between five to less than 26 years.
The pivotal Orbit study is a seamless phase II/III study investigating setrusumab for the treatment of OI in children and adults with OI sub-types I, III and IV.
The Orbit study will investigate the effect of setrusumab on fracture rate in patients aged five to less than 26 years with OI sub-types I, III, and IV as compared to placebo.
Shares of Ultragenyx have lost 6.4% so far this year compared with the industry’s decline of 14.9%.
Image Source: Zacks Investment Research
Setrusumab is being developed as part of Ultragenyx’s collaboration and license agreement with UK-based biopharmaceutical company, MereoBioPharma Group plc (MREO - Free Report) .
Ultragenyx entered into a collaboration and license agreement with Mereo for the development of setrusumabin December 2020.
Per the agreement, Ultragenyx will lead global development of setrusumab and commercialize the product in the United States, Turkey and rest of the world, excluding the European Economic Area, United Kingdom and Switzerland, where MREO retains the commercial rights.
Ultragenyx is planning to evaluate setrusumab in other studies.
The company plans to begin a phase III study evaluating setrusumab versus bisphosphonates in patients aged between two to less than five years for the treatment of OI over a period of 12 to 24 months in the second half of 2022.
Ultragenyx is also looking to continue with the study of setrusumab for treating OI in adult patients aged more than 25 years.
The FDA and the European Medicines Agency have granted orphan drug designation to setrusumab for the treatment of OI.
Zacks Rank & Stocks to Consider
Ultragenyx currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Aligos Therapeutics, Inc. (ALGS - Free Report) and Voyager Therapeutics, Inc. (VYGR - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Aligos Therapeutics’ loss per share has narrowed 14.3% for 2022 and 43.7% for 2023 over the past 60 days.
Earnings of ALGS surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 272.3% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.