DUBLIN - Jazz Pharmaceuticals (NASDAQ:JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for zanidatamab, a treatment for HER2-positive biliary tract cancer (BTC).
he FDA's decision follows the submission of a Biologics License Application (BLA) based on promising clinical trial results. If approved, zanidatamab would be the first HER2-targeted therapy specifically indicated for patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024. This expedited review process underscores the urgent need for new treatments for BTC, a form of cancer with a notably poor prognosis.
Zanidatamab's application is supported by data from the Phase 2b HERIZON-BTC-01 clinical trial, which showed a 41.3% confirmed objective response rate. The findings were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023 and published in The Lancet Oncology. Further data will be presented at the ASCO Annual Meeting in 2024.
The ongoing Phase 3 HERIZON-BTC-302 trial is expected to serve as a confirmatory study for zanidatamab, evaluating its efficacy and safety in combination with standard-of-care therapy.
Zanidatamab is a bispecific antibody that binds to two non-overlapping epitopes of the HER2 receptor, a method that has shown promising antitumor activity. The FDA has previously granted the drug Breakthrough Therapy designation for the treatment of HER2 gene-amplified biliary tract cancers, as well as two Fast Track designations and Orphan Drug designations for the treatment of BTC and gastroesophageal adenocarcinoma (GEA).
Biliary tract cancers are rare, accounting for less than 1% of all adult cancers globally. HER2 is a validated target for cancer therapy, and approximately 12,000 people are diagnosed with HER2-positive BTC annually across the U.S., Europe, and Japan.
This news is based on a press release statement from Jazz Pharmaceuticals.
InvestingPro Insights
As Jazz Pharmaceuticals garners FDA attention with its HER2-targeted therapy for biliary tract cancer, the company's financial health and market performance also present a picture of stability and potential growth. An InvestingPro Tip highlights that management has been actively buying back shares, signaling confidence in the company's future. Additionally, the company's net income is expected to grow this year, which could reflect positively on its stock performance.
From a data perspective, Jazz Pharmaceuticals holds a market capitalization of $6.62 billion, with a P/E ratio of 20.03. Further underlining the company's strength, the P/E ratio based on the last twelve months as of Q1 2024 is at 13.23, suggesting the stock may be undervalued relative to earnings. Moreover, the company boasts an impressive gross profit margin of 92.65% for the same period, indicating efficient operations and strong pricing power.
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The financial metrics and management's strategic decisions paint an encouraging picture for Jazz Pharmaceuticals, not only in its pursuit of medical innovation but also as a potentially solid investment. With the company trading near its 52-week low, investors may find this an opportune time to consider the stock, especially when taking into account the company's robust profit margins and anticipated profitability this year. For more detailed information and tips, visit https://www.investing.com/pro/JAZZ.
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