Core Insights - The European Commission has approved VYVGART® (efgartigimod alfa) for subcutaneous injection as a monotherapy for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins [1][4] - VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and introduces a novel mechanism of action for CIDP treatment in over 30 years [2] - The approval is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date, and is valid across all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein [4] Company Overview - Halozyme Therapeutics, Inc. specializes in biopharmaceutical solutions aimed at improving patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [5] - The company has impacted over one million patients through its commercialized products and has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [5] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to enhance patient comfort and adherence [6] Strategic Partnerships - The approval of VYVGART represents a significant milestone in Halozyme's partnership with argenx, expanding access to CIDP treatment in Europe [3] - The company continues to collaborate with various pharmaceutical and biotechnology firms to leverage its ENHANZE® technology for improved drug delivery [5][6]

ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimodRHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designationargenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren’s disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Net ...

Halozyme Therapeutics, Inc. First Quarter Financial & Operating Results NASDAQ: HALO May 6, 2025 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2025 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidan ...

Core Insights - Halozyme Therapeutics, Inc. announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of VYVGART® 1000mg for treating chronic inflammatory demyelinating polyneuropathy (CIDP) [1][4] - VYVGART® is the first targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action for CIDP treatment in over 30 years [2] - The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [5] - The company has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer, impacting over one million patients globally [5] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6] Market Implications - The EC decision on the marketing authorization application is expected within approximately two months, which will apply to all 27 EU Member States and additional countries [1][4] - The approval of VYVGART® could provide a groundbreaking treatment option for patients with rare autoimmune diseases across Europe [3]