VYVGART

Argenx’s VYVGART® demonstrated statistically significant improvements in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients in the ADAPT SERON phase 3 study (p=0.0068). This is the first global Phase 3 study showing benefits across MuSK+, LRP4+, and triple seronegative subtypes. Argenx plans to submit an sBLA to the FDA by the end of 2025 to expand VYVGART’s label. The drug maintained its consistent safety profile. The results position VYVGART as a potential foundational therapy for a broader gMG population.

Halozyme Therapeutics announced the European Commission’s approval of argenx’s VYVGART subcutaneous injection, utilizing Halozyme’s ENHANZE drug delivery technology, for chronic inflammatory demyelinating polyneuropathy (CIDP). This approval, based on positive ADHERE trial data, marks a significant advancement for CIDP treatment and expands drug access across Europe. VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, represents a new treatment mechanism in over three decades. The SC injection can be administered by patients, caregivers, or healthcare professionals.