Jazz Pharma (JAZZ) Gets EU Nod for Cancer Drug Enrylaze
Jazz Pharmaceuticals JAZZ announced that the European Commission (“EC”) has granted approval to its chemotherapy drug Enrylaze (JZP458) for the treatment of acute lymphoblastic leukemia (“ALL”) and lymphoblastic lymphoma (“LBL”) indications.
Following the EC approval, Enrylaze is approved for use as a component of a multi-agent chemotherapeutic regimen for treating ALL and LBL in adults and pediatric patients (aged one month or older) with hypersensitivity or silent inactivation to E. coli-derived asparaginase. The drug can be administered to patients via intravenous infusion and intramuscular injection.
This approval was expected as the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Enrylaze’s approval in July.
The CHMP and EC decisions are based on data from a pivotal phase II/III study, which evaluated the efficacy, safety and tolerability of Enrylaze in patients with ALL or LBL. Data from this study showed that treatment with Enrylaze achieved and maintained nadir serum asparaginase activity (“NSAA”) levels ≥ 0.1 U/mL.
Jazz’s shares have lost 16.7% year to date compared with the industry’s 6.2% decline.
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Enrylaze is already approved for a similar indication in the United States since 2021, where Jazz markets the drug under the brand name Rylaze.
Jazz has a strong oncology portfolio with several hematology/oncology drugs in its portfolio, aiding growth and diversification. It includes two older drugs, Defitelio for treating patients with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction and Vyxeos for treating adults with acute myeloid leukemia. Its oncology portfolio includes two newer drugs, Rylaze and Zepzelca, approved in 2020 for treating patients with metastatic small-cell lung cancer. Management expects to generate approximately $1 billion in product sales from its oncology franchise in 2023.
Jazz Pharmaceuticals PLC Price
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Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Annovis Bio ANVS, Aprea Therapeutics APRE and Novartis NVS, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 22.2%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Aprea Therapeutics’ 2023 loss per share have improved from $4.65 to $3.26. During the same period, the loss estimates per share for 2024 have narrowed down from $1.82 to $1.23. Year to date, shares of Aprea have lost 34.9%.
Earnings of Aprea Therapeutics beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 43.05%. In the last reported quarter, Aprea Therapeutics’ earnings beat estimates by 39.16%.
In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 12.5%.
Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.
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