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JAZZ

Jazz Pharmaceuticals

$177.06

1.12 (0.64%)

16:47
07/19/18
07/19
16:47
07/19/18
16:47

JCO publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos

Jazz Pharmaceuticals announced that data from the pivotal Phase 3 study of Vyxeos (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of Vyxeos compared to 7+3 in 309 patients who were between 60 to 75 years of age with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes, a rapidly progressing and life-threatening blood cancer. The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (2-sided p value = 0.005; HR [95% confidence interval] = 0.69 [0.52, 0.90]). Vyxeos was also associated with a significantly higher remission rate than 7+3 with a complete response rate of 38% versus 26%; p=0.036. In addition, the overall rate of hematopoietic stem cell transplant was 34% in the Vyxeos arm and 25% in the 7+3 arm. The reported adverse reactions with Vyxeos were generally consistent with the known safety profile of cytarabine and daunorubicin therapy. Vyxeos was approved by the U.S. Food and Drug Administration in August 2017, and is the first FDA-approved treatment specifically indicated for adults with newly-diagnosed t-AML or AML-MRC. Data from the study formed the basis of the FDA application and the Marketing Authorization Application (MAA) to the European Medicines Agency's Committee for Medicinal Products for Human Use.

  • 27

    Oct

  • 20

    Dec

JAZZ Jazz Pharmaceuticals
$177.06

1.12 (0.64%)

07/13/18
07/13/18
NO CHANGE
Target $160

Outperform
Evercore ISI says appeals court decision on Xyrem patents a 'non-issue' for Jazz
As previously reported, Evercore ISI analyst Umer Raffat called news that an appeals court found that seven Jazz Pharmaceuticals (JAZZ) patents being challenged by Amneal Pharmaceuticals (AMRX) are invalid a "non-issue," stating that his quick read of today's decision shows it all relates to the REMS patents and the core basis for patent life is the valproate patents. He said the patents that were ruled invalid "are not particularly relevant for Xyrem's patent estate" and he does not find today's ruling "of much significance." Raffat keeps an Outperform rating on Jazz shares, which are down 2% to $175.48 in morning trading.
07/13/18
WELS
07/13/18
NO CHANGE
Target $182
WELS
Outperform
Jazz 'confident' in defending Xyrem in District Court, says Wells Fargo
Following news that the U.S. Court of Appeals for the Federal Circuit affirmed a series of rulings in favor of Amneal Pharmaceuticals (AMRX) that patents owned by Jazz Pharmaceuticals (JAZZ) related to its Xyrem drug are invalid, Wells Fargo analyst David Maris tells investors in a research note that he spoke with Jazz this morning and they said they "feel confident" in defending Xyrem in the District Court should the case go to trial. Additionally, Jazz, which said a trial date has not yet been set, said they have now settled with 8 out of 9 of the District Court challenges. Maris believes the reaction today is "overdone," as Jazz still has a strong portfolio to defend Xyrem and the company has shown a clear willingness to settle.
07/16/18
PIPR
07/16/18
NO CHANGE
Target $211
PIPR
Overweight
Jazz court ruling does not threaten Xyrem durability, says Piper Jaffray
A federal appellate court on Friday affirmed that certain claims surrounding a number of patents covering Jazz Pharmaceuticals' Xyrem REMS program are invalid, Piper Jaffray analyst David Amsellem tells investors in a research note. The analyst would not view the decision as a threat to the durability of Xyrem out to 2023. He continues to believe that Jazz's visibility into earnings growth in the double-digits is high, owing to contribution from newer products. Amsellem believes the company has "significant room for further value creation" and keeps an Overweight rating on Jazz with a $211 price target.
07/16/18
CANT
07/16/18
NO CHANGE
Target $203
CANT
Overweight
Cantor sees 'meaningful upside' in shares of Jazz Pharmaceuticals
Cantor Fitzgerald analyst William Tanner sees "meaningful upside" in shares of Jazz Pharmaceuticals from current levels. The analyst views recent legal developments as positive, "on balance," and thinks any announcement on the business development front "could be a major incremental driver of positive sentiment." He reiterates an Overweight rating on Jazz with a $203 price target.

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