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
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: empasiprubart — Phase 3 MMN data for empasiprubart are expected in December 2026. (December 2026). 3 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, 2026accepted The FDA assigned a PDUFA date of February 18, 2027 for VYVGART in ocular MG.
PDUFA date of February 18, 2027
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
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.