Credit: Shutterstock photoJazz Pharmaceuticals plcJAZZ announced that the marketing authorization application ("MAA") for its leukemia drug, Vyxeos received approval in Europe. The drug is approved for the treatment of newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adult patients.
The drug was approved in the United States for similar indications in August 2017. It generated sales of $54.2 million in the first six months of 2018. However, the company has lowered full-year revenue guidance for the drug as it performed below company's expectations. The company will launch the drug country-by-country as and when pricing and reimbursement decisions are made. The impact of this approval on drug's sales remains to be seen.
Jazz's shares have returned 24.4% so far this year, outperforming the industry 's gain of mere 0.9%.
The MAA included data from five clinical studies, including a pivotal phase III study, which compared Vyxeos (cytarabine and daunorubicin liposome injection) to the current standard-of-care (7+3 chemotherapy regimen). The drug achieved a median overall survival of 9.6 months versus 5.9 months for standard of care. Vyxeos also achieved superiority in complete response rate.
Acute myeloid leukemia is progressive and a life-threatening blood cancer, which originates in bone marrow and spreads to other parts of the body through blood. Moreover, t-AML and AML-MRC have poor prognosis compared to other forms of leukemia and have limited treatment options available. Thus, there is significant unmet need in the targeted area.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stocks to Consider
Jazz currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Endo International plc ENDP , BioSpecifics Technologies Corp BSTC and Pacira Pharmaceuticals, Inc. PCRX . All the stocks sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today's Zacks #1 Rank stocks here .
Endo's earnings per share estimates have increased from $2.39 to $2.60 for 2018 and from $2.54 to $2.69 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 29.11%. The stock has rallied 100.6% so far this year.
BioSpecifics' earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 19.5% so far this year.
Pacira's earnings per share estimates have increased from 28 cents to 52 cents for 2018 and from $1.05 to $1.08 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 172.92%. The stock has increased 1.2% so far this year.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
