argenx

Argenx (ARGX) reported Q3 2025 global product net sales of $1.13B and total operating income of $1.15B. Operating profit reached $346M, with $4.3B in cash and financial assets. The company reaffirmed its ~$2.5B combined R&D and SG&A guidance and plans to file an sBLA for seronegative gMG by year-end 2025, with ADAPT-OCULUS results expected in 1H26. Five registrational readouts are anticipated in 2026. A FUJIFILM manufacturing partnership expanded with a new North Carolina site.

Argenx will present over 40 abstracts at the 2025 AANEM/MGFA meeting, highlighting data on VYVGART (IV and SC) and empasiprubart. Key presentations include ADAPT SERON results showing VYVGART’s efficacy in AChR antibody-negative gMG, interim ADAPT Jr data in juvenile gMG, and Phase 2/3 empasiprubart programs for CIDP and MMN (EMVIGORATE, EMNERGIZE, EMPASSION). Real-world evidence and long-term data will also be presented, reinforcing VYVGART’s sustained benefit. The conference will address concerns of allergic risks and infection management.

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.