Jazz Pharmaceuticals plc JAZZ announced that it has enrolled the first patient in the pivotal phase II/III study evaluating its novel asparaginase JZP-458 as a potential treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases.
In October, the FDA granted a Fast Track designation to JZP-458 for treating the given patient population.
This single-arm, open-label dose confirmation and confirmatory study is being conducted in collaboration with Children's Oncology Group.
Per the company, the study will assess the safety, tolerability and efficacy of JZP-458 in patients with ALL/LBL who have silent inactivation or an allergic reaction to E. coli-derived asparaginases having received no prior asparaginase Erwinia chrysanthemi.
The primary objective of the study is to determine the efficacy of JZP-458 measured by asparaginase activity.
Shares of Jazz have rallied 19.9% in the past year compared with the industry’s increase of 12.9%.
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Jazz has several hematology/oncology drugs in its portfolio, aiding growth and diversification. Moreover, the company added several drugs to its marketed portfolio as well as clinical-stage candidates to its pipeline through acquisitions or collaborations.
With the Celator consolidation, Jazz added Vyxeos to its pipeline. Vyxeos is marketed in the United States for the treatment of acute myeloid leukemia (AML). Jazz is strengthening its dedicated AML sales team for reaching out to a wider physician community and promoting the recent inclusion in the guidelines of the National Comprehensive Cancer Network (NCCN). Sales of the drug improved in the past couple of quarters on the back of the company’s efforts.
Meanwhile, Jazz is also evaluating Vyxeos in other AML patient populations, such as pediatric patients and adults with standard or intermediate risk AML in combination with targeted AML treatments as well as in new populations (MDS).
Zacks Rank & Other Stocks to Consider
Jazz currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include AcelRx Pharmaceuticals, Inc. ACRX, Innoviva, Inc. INVA and Guardant Health, Inc. GH, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AcelRx Pharmaceuticals’ loss per share estimates have narrowed 6.7% for 2020 over the past 60 days.
Innoviva’s earnings estimates have moved 25.2% north for 2020 over the past 60 days.
Guardant Health’s loss per share estimates have narrowed 8.5% for 2020 over the past 60 days. The stock has skyrocketed 107.2% so far this year.
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