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Amgen's (AMGN) Xgeva Meets Endpoint in Phase III Study
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Amgen Inc.(AMGN - Free Report) announced that a phase III study on its marketed drug, Xgeva for the prevention of skeletal-related events (SRE) in patients with multiple myeloma met the primary endpoint.
Xgevais is approved in the U.S.and the EU for the prevention of SREs in patients with bone metastases from solid tumors. However, it is not indicated for the prevention of SREs in patients with multiple myeloma. Xgeva is also approved in the U.S.for the treatment of giant cell tumor of bone (GCTB), in adults and skeletally mature adolescents, which cannot be treated with surgery.
The study (n=1,718), comparing Xgeva to zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study SRE in patients with multiple myeloma.
However, the secondary endpoints, delaying time to first SRE and delaying time to first-and-subsequent SRE of the study have not met.
Patients treated with Xgeva were observed to have some side effects which are common with the well-known safety profile of the drug. Diarrhea and nausea were the most familiar side effects seen in the Xgeva arm of the study.
Notably, Xgeva delivered revenues of $381 million in the second quarter of 2016, up 15% from the year-ago quarter mainly due to higher demand.
Other than Xgeva, Amgen is also evaluating currently marketed products like Prolia Vectibix and Aranesp for additional indications. Results from several pivotal programs are expected in the upcoming quarter.
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Bioblast Pharma Ltd. , Geron Corporation (GERN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the companies sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Bioblast Pharma recorded an average positive surprise of 51.66% for the last four quarters.
Geron has an average positive surprise of 20.78% for the last four quarters.
Exelixis has an average positive surprise of 9.10% for the trailing four quarters. Its share price has surged more than 100% year to date.
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Amgen's (AMGN) Xgeva Meets Endpoint in Phase III Study
Amgen Inc.(AMGN - Free Report) announced that a phase III study on its marketed drug, Xgeva for the prevention of skeletal-related events (SRE) in patients with multiple myeloma met the primary endpoint.
Xgevais is approved in the U.S.and the EU for the prevention of SREs in patients with bone metastases from solid tumors. However, it is not indicated for the prevention of SREs in patients with multiple myeloma. Xgeva is also approved in the U.S.for the treatment of giant cell tumor of bone (GCTB), in adults and skeletally mature adolescents, which cannot be treated with surgery.
The study (n=1,718), comparing Xgeva to zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study SRE in patients with multiple myeloma.
AMGEN INC Price
AMGEN INC Price | AMGEN INC Quote
However, the secondary endpoints, delaying time to first SRE and delaying time to first-and-subsequent SRE of the study have not met.
Patients treated with Xgeva were observed to have some side effects which are common with the well-known safety profile of the drug. Diarrhea and nausea were the most familiar side effects seen in the Xgeva arm of the study.
Notably, Xgeva delivered revenues of $381 million in the second quarter of 2016, up 15% from the year-ago quarter mainly due to higher demand.
Other than Xgeva, Amgen is also evaluating currently marketed products like Prolia Vectibix and Aranesp for additional indications. Results from several pivotal programs are expected in the upcoming quarter.
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Bioblast Pharma Ltd. , Geron Corporation (GERN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the companies sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Bioblast Pharma recorded an average positive surprise of 51.66% for the last four quarters.
Geron has an average positive surprise of 20.78% for the last four quarters.
Exelixis has an average positive surprise of 9.10% for the trailing four quarters. Its share price has surged more than 100% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>