Core Insights - Halozyme Therapeutics announced the European Commission approval for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE® for treating high-risk smouldering multiple myeloma (SMM) [1][2] - This approval marks a significant advancement in early intervention strategies for multiple myeloma, addressing critical patient needs [2] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical firms, including Roche, Takeda, and Pfizer, among others [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is involved in ongoing product development with various partners [5] Clinical Study Insights - The EC approval is based on data from the Phase 3 AQUILA study, which compared the efficacy and safety of daratumumab SC monotherapy against active monitoring in high-risk SMM patients [3]