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Bristol-Myers Yervoy Gets Positive CHMP Opinion for Melanoma
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Yervoy for pediatric patients of 12 years and older with unresectable or metastatic melanoma.
We note that the European Commission will take the CHMP recommendation into account while considering the application but is not bound by it.
The FDA had approved the drug for the same indication in July 2017.
We remind investors that Yervoy 3 mg/ kg monotherapy was approved in 2011.
So far this year, Bristol-Myers’ shares have rallied 9.6% compared with the industry's gain of 20.9%.
Last week, the company announced that the FDA has accepted its supplemental Biologics License Application for priority review of Opdivo plus Yervoy for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The application is based on data from the phase III study, Checkmate-214. The study was stopped ahead of schedule based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The study evaluated the combination of Opdivo plus Yervoy versus Sutent for previously untreated advanced or metastatic RCC. The FDA will make a decision by Apr 16, 2018.
Meanwhile, the company continues to evaluate its blockbuster immune-oncology drug Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the combination into additional indications will give the product an access to a higher patient population and increase its commercial potential.
However, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic non-squamous NSCLC, the company is expected to suffer further loss of market share.
The virology business is also under pressure. The company is also looking to counter generic threat for key drugs through deals and acquisitions. The company recently entered into a deal with AbbVie, Inc. (ABBV - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) .
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Image: Bigstock
Bristol-Myers Yervoy Gets Positive CHMP Opinion for Melanoma
Bristol-Myers Squibb Company (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Yervoy for pediatric patients of 12 years and older with unresectable or metastatic melanoma.
We note that the European Commission will take the CHMP recommendation into account while considering the application but is not bound by it.
The FDA had approved the drug for the same indication in July 2017.
We remind investors that Yervoy 3 mg/ kg monotherapy was approved in 2011.
So far this year, Bristol-Myers’ shares have rallied 9.6% compared with the industry's gain of 20.9%.
Last week, the company announced that the FDA has accepted its supplemental Biologics License Application for priority review of Opdivo plus Yervoy for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The application is based on data from the phase III study, Checkmate-214. The study was stopped ahead of schedule based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The study evaluated the combination of Opdivo plus Yervoy versus Sutent for previously untreated advanced or metastatic RCC. The FDA will make a decision by Apr 16, 2018.
Meanwhile, the company continues to evaluate its blockbuster immune-oncology drug Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the combination into additional indications will give the product an access to a higher patient population and increase its commercial potential.
However, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic non-squamous NSCLC, the company is expected to suffer further loss of market share.
The virology business is also under pressure. The company is also looking to counter generic threat for key drugs through deals and acquisitions. The company recently entered into a deal with AbbVie, Inc. (ABBV - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) .
Zacks Rank
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
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