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Jazz Pharma Completes NDA Filing for Leukemia Drug to FDA
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Jazz Pharmaceuticals plc (JAZZ - Free Report) recently announced that it has completed the rolling submission of a new drug application (NDA) to the FDA, seeking approval for its experimental candidate, Vyxeos (cytarabine and daunorubicin liposome injection). The product will be used for the treatment of acute myeloid leukemia (AML).
We note that Vyxeos, which became part of the company’s pipeline following the Jul 2016 Celator acquisition, has Fast Track designation in the U.S. The company intends to seek priority review for the candidate as well.
Moreover, Vyxeos enjoys Breakthrough Therapy designation and was even granted Orphan Drug status by the FDA and the European Commission for AML. The company expects to submit a marketing authorization application (MAA) to EMA in the second half of 2017.
Jazz’s shares have outperformed the Zacks classified Medical-Drugs Market industry so far this year. Shares of the company gained 31.2% while the industry registered an increase of 2.6%.
Coming back to the latest news, the rolling submission of NDA was supported by clinical data from five studies, including a pivotal phase III study. Data from the phase III study met its primary endpoint and were presented at the American Society of Clinical Oncology Annual Meeting in Jun 2016.
AML is a life-threatening blood cancer, which according to estimates by the American Cancer Society, is likely to result in more than 10,000 deaths in the U.S. in 2017. The American Cancer Society estimates that there will be more than 21,000 new cases of AML in the country this year. Hence, the potential market opportunity for the drug is huge in the U.S.
Please note that no new approved therapies demonstrated overall survival benefit in AML in over 20 years in the U.S. No doubt, an approval will be a huge boost for the company as Vyxeos has the potential to generate blockbuster sales in the target markets.
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
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Jazz Pharma Completes NDA Filing for Leukemia Drug to FDA
Jazz Pharmaceuticals plc (JAZZ - Free Report) recently announced that it has completed the rolling submission of a new drug application (NDA) to the FDA, seeking approval for its experimental candidate, Vyxeos (cytarabine and daunorubicin liposome injection). The product will be used for the treatment of acute myeloid leukemia (AML).
We note that Vyxeos, which became part of the company’s pipeline following the Jul 2016 Celator acquisition, has Fast Track designation in the U.S. The company intends to seek priority review for the candidate as well.
Moreover, Vyxeos enjoys Breakthrough Therapy designation and was even granted Orphan Drug status by the FDA and the European Commission for AML. The company expects to submit a marketing authorization application (MAA) to EMA in the second half of 2017.
Jazz’s shares have outperformed the Zacks classified Medical-Drugs Market industry so far this year. Shares of the company gained 31.2% while the industry registered an increase of 2.6%.
Coming back to the latest news, the rolling submission of NDA was supported by clinical data from five studies, including a pivotal phase III study. Data from the phase III study met its primary endpoint and were presented at the American Society of Clinical Oncology Annual Meeting in Jun 2016.
AML is a life-threatening blood cancer, which according to estimates by the American Cancer Society, is likely to result in more than 10,000 deaths in the U.S. in 2017. The American Cancer Society estimates that there will be more than 21,000 new cases of AML in the country this year. Hence, the potential market opportunity for the drug is huge in the U.S.
Please note that no new approved therapies demonstrated overall survival benefit in AML in over 20 years in the U.S. No doubt, an approval will be a huge boost for the company as Vyxeos has the potential to generate blockbuster sales in the target markets.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Key Picks
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>