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Jazz's Aggressive Lung Cancer Drug Zepzelca Gets FDA Approval
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Jazz Pharmaceuticals plc (JAZZ - Free Report) and partner PharmaMar announced that the FDA has granted accelerated approval to their selective inhibitor, lurbinectedin, as a monotherapy for metastatic small cell lung cancer (SCLC) in patients whose disease progressed on or after platinum-based chemotherapy. The drug will be commercially available in the U.S. market under the tradename of Zepzelca from early July. SCLC is a very aggressive cancer that usually is diagnosed with advanced, often metastatic disease.
The approval was based on data from a phase II monotherapy study, which evaluated an intravenous infusion, Zepzelca in platinum-sensitive and platinum-resistant SCLC patients. Data from the study showed that objective response rate (“ORR”) was 35% and the median duration of response (DoR) was 5.3 months, as measured by investigator assessment. However, ORR and median DoR were 30% and 5.1 months, respectively, per an independent review committee.
Continued approval to Zepzelca is contingent upon verification and description of clinical benefit in a confirmatory study.
Please note that Jazz entered into an exclusive license agreement with Spain-based Pharma Mar in December 2019, gaining U.S. commercialization rights to lurbinectedin.
Following the FDA approval, shares were up 5.6% on Monday. This year so far, Jazz’s shares have declined 26% compared with the industry’s decrease of 8.2%.
Apart from Zepzelca, Jazz has two marketed cancer drugs in its portfolio — Erwinaze and Vyxeos. Please note that a key drug in the company’s marketed portfolio is its sleep drug, Xyrem, which generates more than 75% of its product revenues. It also has another drug, Sunosi, in its sleep disorder portfolio.
Meanwhile, Jazz has developed JZP-258, a low sodium formulation and a Xyrem follow-on product, to treat EDS and cataplexy in narcolepsy patients. A new drug application for JZP-258 was accepted and granted priority review by the FDA in March. The FDA’s decision is expected by Jul 21. The company plans to launch the candidate by the second half of this year following its potential approval.
JZP-258 is also being studied for idiopathic hypersomnia or IH in a phase III study. Enrollment in the study was completed in the first quarter.
Apart from JZP-258, the company is also developing JZP-458 in a pivotal phase II/III study for the treatment of ALL and lymphoblastic lymphoma. Jazz plans to submit a biologics license application to the FDA for JZP-458 in the fourth quarter of 2020.
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the drug sector include Bellicum Pharmaceuticals, Inc. , Actinium Pharmaceuticals, Inc. (ATNM - Free Report) and BioLineRx Ltd. . While Bellicum and Actinium currently sport a Zacks Rank #1 (Strong Buy), BioLineRx holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bellicum’s loss per share estimates have narrowed from $12.99 to $9.32 for 2020 and from $18.47 to $13.00 for 2021 over the past 60 days. The company delivered four-quarter average positive earnings surprise of 10.28%.
Actinium’s loss estimates have narrowed from 17 cents to 12 cents for 2020 and from 27 cents to 16 cents for 2021 over the past 60 days. The company delivered four-quarter average positive earnings surprise of 8.34%. Its shares have risen 86.7% so far this year.
BioLineRx’s loss per share estimates have narrowed from $2.77 to $2.24 for 2020 and from $3.01 to $2.88 for 2021 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with the average being 27.58%.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.1% per year.
These 7 were selected because of their superior potential for immediate breakout.
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Jazz's Aggressive Lung Cancer Drug Zepzelca Gets FDA Approval
Jazz Pharmaceuticals plc (JAZZ - Free Report) and partner PharmaMar announced that the FDA has granted accelerated approval to their selective inhibitor, lurbinectedin, as a monotherapy for metastatic small cell lung cancer (SCLC) in patients whose disease progressed on or after platinum-based chemotherapy. The drug will be commercially available in the U.S. market under the tradename of Zepzelca from early July. SCLC is a very aggressive cancer that usually is diagnosed with advanced, often metastatic disease.
The approval was based on data from a phase II monotherapy study, which evaluated an intravenous infusion, Zepzelca in platinum-sensitive and platinum-resistant SCLC patients. Data from the study showed that objective response rate (“ORR”) was 35% and the median duration of response (DoR) was 5.3 months, as measured by investigator assessment. However, ORR and median DoR were 30% and 5.1 months, respectively, per an independent review committee.
Continued approval to Zepzelca is contingent upon verification and description of clinical benefit in a confirmatory study.
Please note that Jazz entered into an exclusive license agreement with Spain-based Pharma Mar in December 2019, gaining U.S. commercialization rights to lurbinectedin.
Following the FDA approval, shares were up 5.6% on Monday. This year so far, Jazz’s shares have declined 26% compared with the industry’s decrease of 8.2%.
Apart from Zepzelca, Jazz has two marketed cancer drugs in its portfolio — Erwinaze and Vyxeos. Please note that a key drug in the company’s marketed portfolio is its sleep drug, Xyrem, which generates more than 75% of its product revenues. It also has another drug, Sunosi, in its sleep disorder portfolio.
Meanwhile, Jazz has developed JZP-258, a low sodium formulation and a Xyrem follow-on product, to treat EDS and cataplexy in narcolepsy patients. A new drug application for JZP-258 was accepted and granted priority review by the FDA in March. The FDA’s decision is expected by Jul 21. The company plans to launch the candidate by the second half of this year following its potential approval.
JZP-258 is also being studied for idiopathic hypersomnia or IH in a phase III study. Enrollment in the study was completed in the first quarter.
Apart from JZP-258, the company is also developing JZP-458 in a pivotal phase II/III study for the treatment of ALL and lymphoblastic lymphoma. Jazz plans to submit a biologics license application to the FDA for JZP-458 in the fourth quarter of 2020.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the drug sector include Bellicum Pharmaceuticals, Inc. , Actinium Pharmaceuticals, Inc. (ATNM - Free Report) and BioLineRx Ltd. . While Bellicum and Actinium currently sport a Zacks Rank #1 (Strong Buy), BioLineRx holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bellicum’s loss per share estimates have narrowed from $12.99 to $9.32 for 2020 and from $18.47 to $13.00 for 2021 over the past 60 days. The company delivered four-quarter average positive earnings surprise of 10.28%.
Actinium’s loss estimates have narrowed from 17 cents to 12 cents for 2020 and from 27 cents to 16 cents for 2021 over the past 60 days. The company delivered four-quarter average positive earnings surprise of 8.34%. Its shares have risen 86.7% so far this year.
BioLineRx’s loss per share estimates have narrowed from $2.77 to $2.24 for 2020 and from $3.01 to $2.88 for 2021 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with the average being 27.58%.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.1% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>