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DUBLIN - Jazz Pharmaceuticals plc (NASDAQ:JAZZ), a biopharmaceutical company with impressive gross profit margins of 92% and a "GREAT" financial health rating according to InvestingPro, today shared long-term data from its Phase 2 trial of Ziihera® (zanidatamab-hrii), showing a median overall survival (OS) of 36.5 months in patients with advanced gastroesophageal adenocarcinoma. The findings, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, reveal that Ziihera, when combined with chemotherapy, offers a potentially effective first-line treatment for HER2-positive nonresectable gastroesophageal adenocarcinoma (mGEA).
The study involved 46 patients with HER2-expressing mGEA, with 41 having centrally confirmed HER2-positive tumors. Results indicated a median progression-free survival (PFS) of 15.2 months and a median OS of 36.5 months, with the longest observed survival at 57.9 months. The company’s strong market position is reflected in its conservative P/E ratio of 13.86 and solid liquidity position, with current assets more than triple its short-term obligations. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value calculations. The data, which also appeared in The Lancet Oncology, highlighted the therapy’s sustained antitumor activity and manageable safety profile over four years of follow-up.
Dr. Elena Elimova, lead trial investigator, emphasized the significance of these findings for a patient population with limited treatment options and a poor prognosis. Rob Iannone, M.D., M.S.C.E., of Jazz Pharmaceuticals, noted the encouraging survival outcomes compared to standard care, which typically shows median survival between 15 to 20 months.
The safety profile of Ziihera combined with chemotherapy was consistent with previous reports. The most common Grade 3-4 treatment-related adverse events were diarrhea and hypokalemia. Importantly, there were no treatment-related deaths, and five patients discontinued due to treatment-related adverse events.
Jazz Pharmaceuticals anticipates top-line results from the Phase 3 HERIZON-GEA-01 trial later in the year, which could further establish Ziihera as a treatment for HER2-positive mGEA. Ziihera has already been granted accelerated approval by the FDA for previously treated, unresectable or metastatic HER2-positive biliary tract cancer based on response rate and duration of response.
This article is based on a press release statement from Jazz Pharmaceuticals plc. For deeper insights into Jazz Pharmaceuticals’ financial health, growth prospects, and 10+ additional ProTips, visit InvestingPro, where you’ll find comprehensive Pro Research Reports that transform complex Wall Street data into actionable intelligence.
In other recent news, Jazz Pharmaceuticals reported first-quarter earnings that significantly missed analyst expectations. The company posted adjusted earnings per share of $1.68, falling short of the consensus estimate of $4.81. Revenue for the quarter was $897.8 million, below the anticipated $983.9 million. The earnings shortfall was primarily due to a $172 million expense related to Xyrem antitrust litigation settlements, impacting results by $146.3 million after tax. Consequently, Jazz Pharmaceuticals has revised its full-year 2025 adjusted EPS guidance to a range of $4.00 to $5.60, a sharp decrease from the previous outlook of $22.50 to $24.00, and well below the $23.23 analyst consensus. Despite this, the company maintained its revenue forecast of $4.15 billion to $4.40 billion. In terms of product performance, Xywav and Epidiolex showed strong sales growth, with increases of 9% and 10% year-over-year, respectively. Jazz also completed its acquisition of Chimerix, adding a late-stage pipeline candidate for a rare brain tumor. The company anticipates top-line data from a zanidatamab trial in gastric cancer in the latter half of 2025.
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