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Blog Coverage: Bristol-Myers Squibs Received EMA Validation of Sprycel for the Treatment in Children with Chronic Myelogenous Leukemia

Monday, 22 May 2017 08:15 AM

Active Wall Street

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LONDON, UK / ACCESSWIRE / May 22, 2017 / Active Wall St. blog coverage looks at the headline from Bristol-Myers Squibb Co. (NYSE: BMY) as the Company announced on May 19, 2017, that the European Medicines Agency (EMA) validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1 to 18 years with chronic phase Philadelphia chromosome positive chronic Myelogenous leukemia (CML). The agency also included the powder for oral suspension. Bristol-Myers Squibb stated that the validation of the application confirms the submission is complete and begins the EMA's centralized review process. Register with us now for your free membership and blog access at:

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One of Bristol-Myers Squibb's competitors within the Drug Manufacturers - Major space, GW Pharmaceuticals PLC (NASDAQ: GWPH), announced on May 09, 2017, its financial results for the second quarter ended 31 March 2017. AWS will be initiating a research report on GW Pharma in the coming days.

Today, AWS is promoting its blog coverage on BMY; touching on GWPH. Get all of our free blog coverage and more by clicking on the link below:

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"Treatment options for pediatric patients with chronic phase CML, along with formulations that support the unique demands of children with cancer continue to be unmet needs," said Murdo Gordon, Executive Vice President and Chief Commercial Officer at Bristol-Myers Squibb, "Building on our long-standing heritage in hematology, including the use of Sprycel for more than a decade to treat adults with certain forms of CML, the validation of this application supports our commitment to expand options for children and adolescents with different types of cancer."

Bristol-Myers Squibb's application included data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel in newly diagnosed chronic phase CML pediatric patients and in pediatric patients resistant to or intolerant of imatinib. The Company will be presenting data from this study at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on June 05, 2017.

What is Sprycel?

Bristol-Myers Squibb's Sprycel was first approved by the FDA in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.

Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML, since October 2010. Sprycel received accelerated FDA approval for this indication. Additional country approvals for this indication total more than 50.

FDA Approved Indications for SPRYCEL

SPRYCEL is approved for the treatment of newly diagnosed adults with Ph+ CML in chronic phase. Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and Ph+ ALL with resistance or intolerance to prior therapy.

Stock Performance

At the close of trading session on Friday, May 19, 2017, Bristol-Myers Squibb's stock price was marginally up by 0.45% to end the day at $54.02. A total volume of 8.63 million shares were exchanged during the session. The Company's share price has gained 1.09% in the past one month. The Company's shares are trading at a PE ratio of 18.73 and have a dividend yield of 2.89%. The stock currently has a market cap of $89.78 billion.

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