U.S. markets closed
  • S&P Futures

    4,471.00
    -3.25 (-0.07%)
     
  • Dow Futures

    34,732.00
    -17.00 (-0.05%)
     
  • Nasdaq Futures

    15,500.50
    -17.25 (-0.11%)
     
  • Russell 2000 Futures

    2,223.90
    -4.00 (-0.18%)
     
  • Crude Oil

    72.63
    +0.02 (+0.03%)
     
  • Gold

    1,756.10
    -0.60 (-0.03%)
     
  • Silver

    22.83
    +0.03 (+0.14%)
     
  • EUR/USD

    1.1765
    -0.0007 (-0.06%)
     
  • 10-Yr Bond

    1.3310
    +0.0270 (+2.07%)
     
  • Vix

    18.69
    +0.51 (+2.81%)
     
  • GBP/USD

    1.3786
    -0.0010 (-0.07%)
     
  • USD/JPY

    109.8800
    +0.1620 (+0.15%)
     
  • BTC-USD

    48,015.84
    +25.34 (+0.05%)
     
  • CMC Crypto 200

    1,231.08
    -2.21 (-0.18%)
     
  • FTSE 100

    7,027.48
    +10.99 (+0.16%)
     
  • Nikkei 225

    30,454.27
    +130.93 (+0.43%)
     

Jazz (JAZZ) Initiates BLA Submission for Leukemia Candidate

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

Jazz Pharmaceuticals plc JAZZ 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, ASLAN Pharmaceuticals Ltd. ASLN and Alimera Sciences Inc. ALIM, 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.

Jazz Pharmaceuticals PLC Price

Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price

Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote

Biggest Tech Breakthrough in a Generation

Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.

See 8 breakthrough stocks now>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report
 
Alimera Sciences, Inc. (ALIM) : Free Stock Analysis Report
 
Aerpio Pharmaceuticals, Inc. (ARPO) : Free Stock Analysis Report
 
ASLAN Pharmaceuticals Ltd. (ASLN) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research