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Jazz Initiates Rolling NDA for Leukemia Candidate Vyxeos

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Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that it has started the submission of a rolling New Drug Application (NDA) to the FDA, seeking an approval for its experimental candidate Vyxeos for the treatment of acute myeloid leukemia (AML).

The submission is expected to be complete by early 2017. Vyxeos (cytarabine and daunorubicin liposome injection), 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.

Vyxeos has demonstrated statistically significant improvement in overall survival in trials conducted on patients with high-risk (secondary) AML.

AML is a life-threatening blood cancer, which according to estimates by the American Cancer Society, will result in 10,430 deaths in the U.S. in 2016. The American Cancer Society estimates there will be 19,950 new cases of AML in the country this year, while the number will be 20,100 in the EU. An approval would be a huge boost for the company as Vyxeos has the potential to generate blockbuster sales in the target markets.

Jazz Pharmaceuticals has a Zacks Rank #5 (Strong Sell).

Stocks to Consider

Some better-ranked stocks in the healthcare sector include Achillion Pharmaceuticals, Inc. (ACHN - Free Report) , Anika Therapeutics Inc (ANIK - Free Report) and Geron Corporation . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Achillion Pharmaceuticals has delivered positive earnings surprises in all the past four quarters with an average of 364.79%. Its loss estimates for 2016 have narrowed from 66 cents to 62 cents in the past 60 days.

Geron has delivered positive earnings surprises in all of the past four quarters, bringing the average beat to 20.78%. Its loss estimates for 2016 have narrowed from 26 cents to 24 cents in the past 60 days.

Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.5% and 11.5% over the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters with an average beat of 42.19%. Its share price has jumped 25% year to date.

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