We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amgen Gets CHMP Nod to Add ENDEAVOR Data on Kyprolis Label
Read MoreHide Full Article
Amgen (AMGN - Free Report) announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending addition of an updated overall survival (OS) data from a phase III head-to-head study on the label of its multiple myeloma drug, Kyprolis (carfilzomib).
The phase III ENDEAVOR study was conducted on 929 patients. Data from the trial demonstrated that a combination of Kyprolis plus dexamethasone (Kd) led to superior overall survival when compared with Takeda Pharmaceutical’s Velcade plus dexamethasone (Vd) in second-line multiple myeloma setting. Findings showed that the combination therapy reduced the risk of death by 21% and increased OS by 7.6 months compared with Vd in the given patients’ population.
Importantly, in January 2018, Amgen announced that the FDA has approved its supplemental New Drug Application (sNDA) to include OS data from the ENDEAVOR program on Kyprolis’ label. The FDA’s decision comes much earlier than expected, initially expected in April this year.
Note that the Kd regimen is already approved in the United States, EU and other countries based on the primary analysis of a progression-free survival in the ENDEAVOR study. This overall survival data, if approved, can help drive the usage of Kyprolis and boost its sales.
We remind investors that Kyprolis is also approved in the United States as a single agent for treating patients with multiple myeloma, who have received at least two prior therapies including Velcade and an immunomodulatory agent.
Significantly, Amgen collaborated with Johnson & Johnson (JNJ - Free Report) in November 2016 to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for addressing the case of multiple myeloma. Under the terms of the agreement, the first study — a phase III registrational trial, evaluating the combo therapy of Kyprolis/Darzalex and dexamethasone compared with Kyprolis and dexamethasone alone on patients with multiple myeloma, having undergone one, two or three prior lines of therapy — has been initiated.
Amgen’s shares have outperformed the industry in a year’s time. The stock has rallied 22.1%, comparing favorably with the industry’s increase of 8%.
Incidentally, Kyprolis, which became part of Amgen’s portfolio following its acquisition of Onyx, registered sales of $608 million in the first nine months of 2017, up 18.9% compared with the year-ago figure. The drug’s label expansion would immensely expand the patient population as well as its commercial potential.
Per the company’s press release, multiple myeloma is an aggressive disease, accounting for approximately one percent of all cancers. Moreover, around 39,000 patients are annually diagnosed with multiple myeloma in Europe, of which, almost 61.5% of the cases proves to be fatal. Hence, the market opportunity of the combination therapy is huge in the EU to cater to the unmet need of patients with an additional option to apprehend the life-threatening disease.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 678.3% in the last 12 months.
Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive surprise in all the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 68.4% in a year’s time.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Amgen Gets CHMP Nod to Add ENDEAVOR Data on Kyprolis Label
Amgen (AMGN - Free Report) announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending addition of an updated overall survival (OS) data from a phase III head-to-head study on the label of its multiple myeloma drug, Kyprolis (carfilzomib).
The phase III ENDEAVOR study was conducted on 929 patients. Data from the trial demonstrated that a combination of Kyprolis plus dexamethasone (Kd) led to superior overall survival when compared with Takeda Pharmaceutical’s Velcade plus dexamethasone (Vd) in second-line multiple myeloma setting. Findings showed that the combination therapy reduced the risk of death by 21% and increased OS by 7.6 months compared with Vd in the given patients’ population.
Importantly, in January 2018, Amgen announced that the FDA has approved its supplemental New Drug Application (sNDA) to include OS data from the ENDEAVOR program on Kyprolis’ label. The FDA’s decision comes much earlier than expected, initially expected in April this year.
Note that the Kd regimen is already approved in the United States, EU and other countries based on the primary analysis of a progression-free survival in the ENDEAVOR study. This overall survival data, if approved, can help drive the usage of Kyprolis and boost its sales.
We remind investors that Kyprolis is also approved in the United States as a single agent for treating patients with multiple myeloma, who have received at least two prior therapies including Velcade and an immunomodulatory agent.
Significantly, Amgen collaborated with Johnson & Johnson (JNJ - Free Report) in November 2016 to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for addressing the case of multiple myeloma. Under the terms of the agreement, the first study — a phase III registrational trial, evaluating the combo therapy of Kyprolis/Darzalex and dexamethasone compared with Kyprolis and dexamethasone alone on patients with multiple myeloma, having undergone one, two or three prior lines of therapy — has been initiated.
Amgen’s shares have outperformed the industry in a year’s time. The stock has rallied 22.1%, comparing favorably with the industry’s increase of 8%.
Incidentally, Kyprolis, which became part of Amgen’s portfolio following its acquisition of Onyx, registered sales of $608 million in the first nine months of 2017, up 18.9% compared with the year-ago figure. The drug’s label expansion would immensely expand the patient population as well as its commercial potential.
Per the company’s press release, multiple myeloma is an aggressive disease, accounting for approximately one percent of all cancers. Moreover, around 39,000 patients are annually diagnosed with multiple myeloma in Europe, of which, almost 61.5% of the cases proves to be fatal. Hence, the market opportunity of the combination therapy is huge in the EU to cater to the unmet need of patients with an additional option to apprehend the life-threatening disease.
Amgen Inc. Price
Amgen Inc. Price | Amgen Inc. Quote
Zacks Rank & Key Picks
Amgen carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are XOMA Corporation (XOMA - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While XOMA sports a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 678.3% in the last 12 months.
Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive surprise in all the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 68.4% in a year’s time.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>