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.
Bristol-Myers' Sprycel Seeks Label Expansion in the U.S.
Read MoreHide Full Article
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA accepted its supplemental Biologics License Application (sBLA) for oncology drug, Sprycel.
The sBLA seeks to get Sprycel’s label expansion for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.
The application was based on positive data from an ongoing phase II trial, CA180-372 (NCT01460160), evaluating the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
The FDA action date is Dec 29, 2018.
We note that Sprycel is already approved in the United States for the treatment of adults with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). The drug also received the FDA approval for adults with Ph+ ALL, who are resistant to or intolerant of prior therapy. The FDA also approved Sprycel’s label to include pediatric patients with Ph+ CML-CP in November 2017 and the European Commission approved the same in July 2018.
Label expansion of existing drugs bode well for Bristol-Myers.
Bristol-Myers’ shares have declined 0.9% year to date compared with the industry’s gain of 5.2%.
While its blockbuster drug, Opdivo continues to perform well and the label expansion of the drug will further boost the top line, pricing concerns and stiff competition in the immuno-oncology space are major concerns. In particular, Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq pose stiff competition.
Hence, the label expansion of other drugs of the company should maintain the top-line momentum.
Eliquis is also expected to drive further growth in 2018, driven by increases in market share in the novel oral anticoagulant (NOAC) market.
Gilead’s earnings per share estimates have increased from $6.11 to $6.58 for 2018 in the last 60 days. Estimates for 2019 are also up by 12 cents.
5 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2018 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025.
Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 5 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains.
Image: Bigstock
Bristol-Myers' Sprycel Seeks Label Expansion in the U.S.
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA accepted its supplemental Biologics License Application (sBLA) for oncology drug, Sprycel.
The sBLA seeks to get Sprycel’s label expansion for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.
The application was based on positive data from an ongoing phase II trial, CA180-372 (NCT01460160), evaluating the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
The FDA action date is Dec 29, 2018.
We note that Sprycel is already approved in the United States for the treatment of adults with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). The drug also received the FDA approval for adults with Ph+ ALL, who are resistant to or intolerant of prior therapy. The FDA also approved Sprycel’s label to include pediatric patients with Ph+ CML-CP in November 2017 and the European Commission approved the same in July 2018.
Label expansion of existing drugs bode well for Bristol-Myers.
Bristol-Myers’ shares have declined 0.9% year to date compared with the industry’s gain of 5.2%.
While its blockbuster drug, Opdivo continues to perform well and the label expansion of the drug will further boost the top line, pricing concerns and stiff competition in the immuno-oncology space are major concerns. In particular, Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq pose stiff competition.
Hence, the label expansion of other drugs of the company should maintain the top-line momentum.
Eliquis is also expected to drive further growth in 2018, driven by increases in market share in the novel oral anticoagulant (NOAC) market.
Zacks Rank and Other Stock to Consider
Bristol-Myers has a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the pharma/biotech sector is Gilead Sciences, Inc. (GILD - Free Report) , which sports a Zacks Rank #1 as well. You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.58 for 2018 in the last 60 days. Estimates for 2019 are also up by 12 cents.
5 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2018 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025.
Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 5 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains.
Click to see them right now >>