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SAN DIEGO – Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission has granted approval for the expanded use of DARZALEX® (daratumumab) in combination with other drugs for the treatment of adult patients with newly diagnosed multiple myeloma. This subcutaneous formulation, which utilizes Halozyme's ENHANZE® drug delivery technology, allows patients to avoid lengthy intravenous infusions, potentially enhancing the treatment experience. The company, currently valued at $7.09 billion, has demonstrated strong financial health with a perfect Piotroski Score of 9, according to InvestingPro data.
The approval enables the use of daratumumab in a subcutaneous form, combined with bortezomib, lenalidomide, and dexamethasone (VRd), following a previous indication extension in October 2024 for patients eligible for autologous stem cell transplant. The decision was based on results from the Phase 3 PERSEUS study, which assessed the efficacy of this quadruplet regimen in both induction and consolidation therapy, followed by maintenance with daratumumab and lenalidomide. With an impressive gross profit margin of 76.51% and revenue growth of 22.44% in the last twelve months, Halozyme appears undervalued according to InvestingPro's Fair Value analysis.
Dr. Helen Torley, President and CEO of Halozyme, remarked on the significance of this approval, emphasizing the potential benefits for newly diagnosed patients who can now receive a more convenient subcutaneous administration of daratumumab plus VRd. Discover more insights about Halozyme's growth potential and 12 additional exclusive ProTips with a subscription to InvestingPro, including detailed analysis in our comprehensive Pro Research Report.
Halozyme, known for its ENHANZE® technology, specializes in improving patient outcomes and experiences with therapies that require subcutaneous delivery. The company's technology is already in use in ten commercialized products and has reached over one million patients across more than 100 global markets.
The European Medicines Agency's Summary of Product Characteristics for DARZALEX provides detailed information on this latest approval, which is expected to offer an alternative to traditional intravenous treatments for multiple myeloma, a cancer of the plasma cells.
The information for this article is based on a press release statement from Halozyme Therapeutics, Inc.
In other recent news, Halozyme Therapeutics, Inc. has announced the European Commission's approval of a new subcutaneous formulation for advanced non-small cell lung cancer treatment, utilizing its ENHANZE® drug delivery technology. This formulation, developed in collaboration with Janssen-Cilag International NV, is designed for adult patients with specific epidermal growth factor receptor mutations. Additionally, the European Medicines Agency's Committee for Medicinal Products for Human Use has given a favorable opinion on Bristol Myers Squibb's Opdivo cancer drug, also developed with Halozyme's ENHANZE technology, with a decision expected by June 2025. In leadership news, Michael J. LaBarre, Halozyme's Senior Vice President and Chief Technical Officer, has retired, marking a notable transition within the company. Meanwhile, Halozyme is facing a patent dispute with Merck & Co., which has contested several of Halozyme's patents related to its hyaluronidase enzyme platform. Despite this challenge, H.C. Wainwright and JMP Securities have maintained their favorable ratings for Halozyme, with price targets of $72 and $78 respectively, indicating confidence in the company's patent position and future prospects.
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