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Jazz (JAZZ) Initiates BLA Submission for Leukemia Candidate

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Jazz Pharmaceuticals plc (JAZZ - Free Report) has initiated the submission of a biologics license application (BLA) to the FDA seeking approval of its novel asparaginase, JZP-458, for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients who are hypersensitive to E. coli-derived asparaginase products.

ALL is a cancer of the blood and bone marrow that can progress quickly if not treated. Asparaginase is an important component of multi-agent chemotherapeutic regimens in ALL.

Shares of Jazz have gained 0.6% year to date compared with the industry's increase of 2.9%.

The BLA filing is based on a pivotal phase II/III study,which is still ongoing. The study is evaluating JZP-458 as a potential treatment forpediatric and adult patients with acute ALL or LBL who are hypersensitive to E. coli-derived asparaginases. This single-arm, open-label dose confirmation and confirmatory study is being conducted in collaboration with Children's Oncology Group.

Once the BLA submission is complete and approved by the FDA, the company expects to launch JZP-458 in mid-2021.

Jazz has several hematology/oncology drugs in its portfolio, aiding growth and diversification.  The company is developing a few oncology candidates and also focused on expanding the labels of marketed drugs — Defitelio and Vyxeos. 

A mid-stage study is evaluating Defitelio for the prevention of CAR T-cell-associated neurotoxicity in patients with relapsed or refractory DLBCL. The company is also developing the drug as a potential treatment for the prevention of acute graft versus host disease (aGVHD). 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 and in new populations (myelodysplastic syndromes, or MDS).

Zacks Rank & Stocks to Consider

Jazz currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. (ARPO - Free Report) , ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 66.8% year to date.

ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 1.5% year to date.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.

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