EC approves new lung cancer treatment using Halozyme technology

Published 07/04/2025, 14:34
EC approves new lung cancer treatment using Halozyme technology

SAN DIEGO - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a $7.36 billion market cap biopharmaceutical company with impressive gross margins of 76.5%, has announced the European Commission’s authorization of a new subcutaneous formulation for advanced non-small cell lung cancer treatment. This formulation, developed by Janssen-Cilag International NV, a Johnson & Johnson company, combines RYBREVANT® (amivantamab) and LAZCLUZE® (lazertinib) for first-line treatment in adult patients with specific epidermal growth factor receptor (EGFR) mutations. It is also approved as monotherapy for patients with EGFR exon 20 insertion mutations after platinum-based therapy failure.

The subcutaneous administration of amivantamab leverages Halozyme’s ENHANZE® drug delivery technology. Dr. Helen Torley, President and CEO of Halozyme, expressed satisfaction with the European approval, highlighting the benefits of reduced administration time and fewer infusion-related reactions, potentially improving the healthcare system. The company’s innovation-driven approach has contributed to its strong financial performance, with revenue growing 22.4% in the last twelve months. According to InvestingPro analysis, Halozyme maintains a perfect Piotroski Score of 9, indicating excellent financial strength.

The approval is backed by positive results from the Phase 3 PALOMA-3 study. The study’s detailed findings are available in a separate press release by Johnson & Johnson.

Halozyme, a biopharmaceutical company, focuses on enhancing patient experiences and outcomes with disruptive solutions for both emerging and established therapies. The ENHANZE® technology, featuring the proprietary enzyme rHuPH20, is designed to facilitate the subcutaneous delivery of injectable drugs and fluids. With over one million patient lives touched across more than 100 global markets, Halozyme has licensed ENHANZE® technology to numerous pharmaceutical and biotechnology firms.

The company also develops and commercializes drug-device combination products, including its proprietary products Hylenex® and XYOSTED®, in collaboration with partners such as Teva Pharmaceuticals and Idorsia Pharmaceuticals.

This news is based on a press release statement from Halozyme Therapeutics, Inc. The company cautions that forward-looking statements included in the press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets as high as $78. Investors seeking deeper insights can access comprehensive financial analysis and 14 additional exclusive ProTips through the InvestingPro platform’s detailed research reports.

In other recent news, Halozyme Therapeutics reported total revenues of $1,015 million for the fiscal year 2024, slightly surpassing consensus estimates but just below H.C. Wainwright’s forecast. The revenue was bolstered by a notable increase in royalty revenues, which reached $571 million, indicating strong demand for products incorporating Halozyme’s ENHANZE technology. In addition, H.C. Wainwright has raised its price target for Halozyme to $72, maintaining a Buy rating, reflecting confidence in the company’s financial health and market position. Meanwhile, Halozyme announced the retirement of its Chief Technical Officer, Michael J. LaBarre, marking a significant transition within the company’s leadership. The company has not yet announced a successor for the CTO position, leaving investors attentive to any forthcoming strategic shifts. Additionally, Halozyme is engaged in a patent dispute with Merck & Co., which has challenged several of Halozyme’s patents related to its enzyme platform. Both H.C. Wainwright and JMP Securities have maintained favorable ratings for Halozyme, with JMP setting a $78 price target, despite the ongoing legal proceedings. These developments come as the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approving a new formulation of Opdivo, developed with Halozyme’s ENHANZE technology, with a decision expected by June 2025.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.