DUBLIN - Jazz Pharmaceuticals plc (NASDAQ:JAZZ) reported promising results from a Phase 2 clinical trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in treating advanced or metastatic gastroesophageal adenocarcinoma (mGEA) that expresses the HER2 protein. The trial, which combined zanidatamab with chemotherapy, involved 41 patients with HER2-positive mGEA and demonstrated a median progression-free survival (mPFS) of 15.2 months.
The study's participants, who were treated at 15 sites across the United States, Canada, and South Korea, had not previously received HER2-targeted agents or systemic treatment for mGEA. The updated data revealed a confirmed objective response rate (cORR) of 84%, with a median duration of response (DoR) of 18.7 months. Additionally, after a median follow-up of 41.5 months, the Kaplan-Meier estimated overall survival (OS) was 59% at 30 months.
Dr. Elena Elimova, the lead trial investigator, emphasized the potential of zanidatamab to address a significant unmet need for patients with HER2-positive GEA. Rob Iannone, Executive Vice President at Jazz Pharmaceuticals, echoed this sentiment and highlighted the potential of zanidatamab as a foundational treatment.
Moreover, Jazz Pharmaceuticals is progressing with the Phase 3 first-line clinical trial HERIZON-GEA-01, with results expected in the second quarter of 2025. The company is also exploring zanidatamab's efficacy in other HER2-expressing solid tumors.
The safety profile of zanidatamab combined with chemotherapy remained manageable, with diarrhea being the most common Grade 3-4 treatment-related adverse event. No new safety concerns were identified, and treatment discontinuations due to adverse events were infrequent.
These findings were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Barcelona, Spain, and are based on a press release statement. The U.S. Food and Drug Administration has granted zanidatamab Priority Review, with a Prescription Drug User Fee Act action date set for November 29, 2024.
Gastroesophageal adenocarcinoma is the fifth most common cancer globally, with approximately 20% of patients having HER2-positive disease. This cancer type has high morbidity and mortality rates, emphasizing the need for effective new treatments.
In other recent news, Jazz Pharmaceuticals has been making significant progress on various fronts. The company posted record revenues in Q2 2024, exceeding the $1 billion mark, largely driven by sales of Xywav and Epidiolex. As a result, Jazz Pharmaceuticals revised its full-year revenue outlook to a range of $4 billion to $4.1 billion. Additionally, the company announced a new $500 million share repurchase authorization.
On the legal front, Jazz Pharmaceuticals emerged victorious in a patent infringement lawsuit against Avadel Pharmaceuticals (NASDAQ:AVDL), securing its rights related to controlled release formulations of oxybate. This development grants Jazz Pharmaceuticals the right to receive ongoing royalties from Avadel for any future sales of Lumryz to narcolepsy patients.
Meanwhile, Jazz Pharmaceuticals' ambitious oncology pursuits, backed by sufficient funding, are yielding promising results. The company's oncology drug, zanidatamab, is currently under exploration as a treatment for HER2-resistant cancers. Stifel has maintained its Buy rating on Jazz Pharmaceuticals, emphasizing the potential of this drug.
However, the company faced a setback with its Phase III study of Epidiolex in Japan, which did not meet its primary endpoint. Despite this, TD Cowen maintains a Buy rating on the company, stating this development does not impact their financial estimates for Jazz Pharmaceuticals.
Lastly, Jazz Pharmaceuticals announced an $850 million note offering through its subsidiary, Jazz Investments I Limited. The proceeds from this offering will be used for various corporate purposes, including prepayment of term loans under its credit agreement. These are among the recent developments surrounding Jazz Pharmaceuticals.
InvestingPro Insights
As Jazz Pharmaceuticals continues to make strides in the clinical development of zanidatamab, investors are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, Jazz Pharmaceuticals boasts a strong gross profit margin of 92.6% over the last twelve months as of Q2 2024, reflecting the company's ability to maintain high profitability relative to its revenue. This is particularly relevant as the company invests in the development of promising treatments like zanidatamab.
Additionally, the company's Price/Earnings (P/E) ratio stands at 17.23, with an adjusted P/E ratio of 11.94 for the same period, suggesting that the company's earnings are robust in relation to its share price. This could be indicative of a potentially undervalued stock, especially considering the InvestingPro Fair Value estimate of 148.43 USD, which is higher than the previous close price of 108.79 USD.
InvestingPro Tips indicate that Jazz Pharmaceuticals' management has been actively engaging in share buybacks, a sign that the company believes its shares are undervalued and a potentially positive signal for investors. Furthermore, the fact that 16 analysts have revised their earnings upwards for the upcoming period points to an optimistic outlook for the company's financial performance.
For investors seeking additional insights, there are 9 more InvestingPro Tips available, offering a comprehensive analysis of Jazz Pharmaceuticals' market and financial metrics. These insights could be particularly valuable for evaluating the company's prospects as it advances its clinical programs and aims to meet significant unmet medical needs.
For more detailed information, investors can explore the full range of InvestingPro Tips at: https://www.investing.com/pro/JAZZ
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