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Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications
HALOHalozyme(HALO) Prnewswire·2025-03-31 12:30

Core Insights - Halozyme Therapeutics announced that Bristol Myers Squibb received a positive opinion from the CHMP for the subcutaneous formulation of Opdivo, which is expected to be approved by the European Commission by June 2, 2025 [1][2][4] - The subcutaneous delivery of Opdivo is anticipated to provide cancer patients with a faster and more flexible treatment option, potentially alleviating pressure on healthcare resources [3][4] - The positive opinion from CHMP is supported by results from the Phase 3 CheckMate -67T trial [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 [5] - The company has licensed its ENHANZE® technology to several leading pharmaceutical and biotechnology companies, including Roche, Takeda, and Pfizer, among others [5] - Halozyme also develops drug-device combination products and has two commercial proprietary products, Hylenex® and XYOSTED®, along with ongoing partnerships and product development programs [6]