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DUBLIN - Jazz Pharmaceuticals plc (NASDAQ:JAZZ), a pharmaceutical company with impressive gross profit margins of 92% and a market capitalization of $6.77 billion, announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). According to InvestingPro analysis, the company maintains a "GREAT" financial health score, positioning it well for this potential market expansion. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for October 7, 2025.
The sNDA submission was based on findings from the Phase 3 IMforte trial, which showed significant improvements in both progression-free survival (PFS) and overall survival (OS) when Zepzelca was combined with atezolizumab, compared to atezolizumab alone. Median PFS reached 5.4 months with the combination therapy versus 2.1 months with the single agent, while median OS was 13.2 months compared to 10.6 months. The company’s strong liquidity position, with current assets more than three times its short-term obligations, provides robust support for continued clinical development and commercialization efforts.
Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, stated that the Priority Review underscores the urgent need for new treatments in ES-SCLC, a condition with limited options and high unmet medical need. The company expressed its commitment to advancing Zepzelca as a potential new treatment that could extend the time patients live without disease progression.
The combination therapy did not produce new or unexpected safety signals, according to the press release. Jazz Pharmaceuticals will host an investor webcast today to discuss the IMforte trial data, with commentary from a leading small cell lung cancer expert and company senior management.
Small cell lung cancer represents about 13 percent of lung cancers in the U.S., with approximately 30,000 new cases reported annually. The disease is aggressive and tends to spread quickly, often returning after initial treatment. With revenue growth of 5.76% over the last twelve months and currently trading below its Fair Value according to InvestingPro analysis, Jazz Pharmaceuticals appears well-positioned to capitalize on this significant market opportunity. For detailed insights and additional ProTips about JAZZ’s market position and growth potential, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
Zepzelca, an alkylating drug that binds guanine residues within DNA, was approved under accelerated approval by the FDA in June 2020 for adult patients with metastatic SCLC who have experienced disease progression on or after platinum-based chemotherapy. The LAGOON trial, a confirmatory Phase 3 clinical study, is currently underway and could support full approval in the U.S. if results are positive.
This news article is based on a press release statement and provides a summary of the key facts without speculation or promotional language.
In other recent news, Jazz Pharmaceuticals reported first-quarter earnings that fell significantly short of analyst expectations, posting an adjusted earnings per share of $1.68 compared to the anticipated $4.81. Revenue also missed projections, coming in at $897.8 million against the expected $983.9 million. The company attributed this shortfall primarily to a $172 million expense related to Xyrem antitrust litigation settlements. As a result, Jazz Pharmaceuticals dramatically lowered its full-year profit outlook, revising its adjusted EPS guidance to between $4.00 and $5.60, down from the previous range of $22.50 to $24.00. Despite this, the company maintained its revenue forecast of $4.15 billion to $4.40 billion.
In other developments, Jazz Pharmaceuticals shared promising data from its Phase 3 IMforte study, where Zepzelca combined with atezolizumab significantly improved survival rates in patients with extensive-stage small cell lung cancer. This combination therapy reduced the risk of disease progression or death by 46% and extended median overall survival to 13.2 months. Additionally, Jazz Pharmaceuticals reported positive outcomes from a Phase 2 trial of Ziihera, showing a median overall survival of 36.5 months in patients with advanced gastroesophageal adenocarcinoma. UBS analysts reaffirmed a Buy rating for Jazz Pharmaceuticals following positive trial data, with a price target of $164.00. Lastly, Jazz completed its acquisition of Chimerix, adding dordaviprone, a late-stage pipeline candidate for a rare brain tumor, to its portfolio.
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