Argenx SE ARGX
Argenx SE (Nasdaq: ARGX) is an immunology/inflammation drug developer. Its lead program, VYVGART, is in Phase 3 for generalized myasthenia gravis, CIDP, ITP. Its next catalyst on record is empasiprubart: Phase 3 MMN data for empasiprubart are expected in December 2026. (December 2026).
Upcoming catalysts
- December 2026empasiprubart — Phase 3 MMN data for empasiprubart are expected in December 2026.
Phase 3 MMN data for empasiprubart expected in December 2026
- February 18, 2027VYVGART (efgartigimod alfa-fcab) — argenx disclosed a PDUFA date of February 18, 2027 for VYVGART in ocular MG.
Ocular MG PDUFA date of February 18, 2027
Next further out: VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) — Argenx is on track to submit a supplemental BLA for VYVGART Hytrulo in IMNM by year-end 2026. (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| VYVGART | gMG, CIDP, ITP (three indications; IV and prefilled syringe presentations) | unclear | Approved |
| VYVGART | seronegative gMG | unclear | Phase 3 |
Recent results and decisions
- Oct 22, 2026submitted argenx submitted an sBLA for VYVGART in ocular myasthenia gravis (oMG) to the FDA.
Submitted a Supplemental Biologics License Application (sBLA) for VYVGART in ocular myasthenia gravis (oMG) to the U.S. Food and Drug Administration (FDA)
Filing - Oct 22, 2026started FB102 is advancing to Phase 3 in celiac disease.
FB102 advancing to Phase 3 in celiac disease as potential new growth pillar in argenx's next wave of immunology innovation
Filing - Oct 22, 2026submitted argenx submitted a Supplemental Biologics License Application (sBLA) to the FDA for VYVGART in ocular myasthenia gravis (oMG).
Submitted a Supplemental Biologics License Application (sBLA) for VYVGART in ocular myasthenia gravis (oMG) to the U.S. Food and Drug Administration (FDA)
Filing
18 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
- Sanofi SNY
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
- Nektar Therapeutics NKTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.