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DUBLIN - Jazz Pharmaceuticals plc (NASDAQ:JAZZ), a biopharmaceutical company with a market capitalization of $8.3 billion and impressive gross profit margins of 92%, announced Thursday that the U.S. Food and Drug Administration has approved Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC). According to InvestingPro data, the company maintains a "GREAT" financial health score of 3.2 out of 5, suggesting strong operational stability.
The approval applies to patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. This marks the first combination therapy approved for first-line maintenance treatment of ES-SCLC, an aggressive form of cancer with limited treatment options.
According to clinical trial results, the combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab maintenance therapy alone. The median overall survival from randomization was 13.2 months for the combination versus 10.6 months for atezolizumab alone. With annual revenues of $4.1 billion and the stock currently trading near its 52-week high, InvestingPro analysis suggests Jazz Pharmaceuticals is undervalued, with 11 analysts recently revising their earnings expectations upward. Get access to detailed valuation metrics and 12 more exclusive ProTips with an InvestingPro subscription.
"The Zepzelca and Tecentriq combination provides a new option and a proactive approach shown to improve progression-free and overall survival in patients who haven’t progressed after standard induction chemotherapy," said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology at Yale Cancer Center.
The National Comprehensive Cancer Network has updated its clinical practice guidelines to include the Zepzelca and atezolizumab combination as a preferred regimen for eligible patients.
The FDA approval is based on results from the Phase 3 IMforte trial. From randomization, median progression-free survival by independent assessment was 5.4 months for the combination versus 2.1 months for atezolizumab alone.
Common adverse reactions included decreased blood cell counts, nausea, and fatigue. Serious adverse reactions occurred in 31% of patients receiving the combination, with fatal adverse reactions in 5%.
Small cell lung cancer accounts for approximately 13% of lung cancers in the U.S., with about 30,000 new cases reported each year, according to information provided in the company’s press release statement. Discover more insights about Jazz Pharmaceuticals’ market position and growth potential in the comprehensive Pro Research Report, available exclusively on InvestingPro, along with in-depth analysis of 1,400+ other top stocks.
In other recent news, Jazz Pharmaceuticals has been in the spotlight with several key developments. Morgan Stanley has increased its price target for Jazz Pharmaceuticals to $167 from $163, maintaining an Overweight rating. This adjustment follows the company’s presentation of data from the Xywav Phase 4 DUET open-label study at the World Sleep conference in Singapore. Additionally, Jazz Pharmaceuticals presented new real-world evidence and Phase 4 data supporting Xywav for narcolepsy and idiopathic hypersomnia at two major medical conferences. Piper Sandler has reiterated its Overweight rating and $147 price target, anticipating Jazz’s upcoming HERIZON-GEA-01 study data release in late 2025. Furthermore, Jazz Pharmaceuticals announced that Modeyso has been added to the NCCN guidelines as a treatment option for certain brain tumors, shortly after receiving FDA approval. Truist Securities also raised its price target for Jazz to $205 from $200, following a webcast on the commercial strategy for Modeyso. These developments highlight significant progress and interest in Jazz Pharmaceuticals’ offerings and strategies.
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