argenx SE (ARGX) catalysts

Upcoming FDA decisions and readouts we track for argenx SE, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 24 Oct 2026

FreeBioList tracks 1 upcoming catalyst for argenx SE (ARGX, listed on Nasdaq). It concerns Efgartigimod (VYVGART / VYVGART Hytrulo) (Generalised myasthenia gravis in children).

First on the list: the PDUFA date for Efgartigimod (VYVGART / VYVGART Hytrulo) (Generalised myasthenia gravis in children), guided by the company to Feb 2027.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 24 Oct 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: ARGX
Next catalyst: Feb 2027
Type: PDUFA date
Listed options: Not yet checked

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
argenx SE ARGX · Nasdaq	Efgartigimod (VYVGART / VYVGART Hytrulo)	Generalised myasthenia gravis in children	Feb 2027 company guidance	PDUFA date	Verified	6-K exhibit ↗	—
Notes — Filing states the "sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG accepted for priority review by the FDA, with a PDUFA target action date in February 2027." The company's results slides give 18 February 2027; the release gives the month only. Source: 6-K exhibit, filed 22 Oct 2026 · verified 24 Oct 2026

Companies working on related conditions

Cartesian Therapeutics (RNAC)Myasthenia gravis (mRNA CAR-T); Myositis; Juvenile dermatomyositis (paediatric); Myasthenia gravis
Roivant Sciences (ROIV)Non-infectious uveitis; Cutaneous lupus erythematosus; Pulmonary hypertension with interstitial lung disease; Difficult-to-treat rheumatoid arthritis; Graves’ d
Tempest Therapeutics (TPST)Myasthenia gravis / multiple sclerosis (CD7 in vivo CAR-T)

Also due in Q1 2027

Biohaven (BHVN)PDUFA date for Vyglxia (troriluzole), Q1 2027
Eton Pharmaceuticals (ETON)PDUFA date for LIBERVANT (diazepam buccal film), 29 Mar 2027
Apnimed (APMD)PDUFA date for AD109 (Oxnimbi), 28 Feb 2027
Cullinan Therapeutics (CGEM)PDUFA date for Zipalertinib, 27 Feb 2027
ImmunityBio (IBRX)PDUFA date for ANKTIVA (nogapendekin alfa) plus BCG, 06 Jan 2027
Unicycive Therapeutics (UNCY)PDUFA date for Oxylanthanum carbonate (OLC), Mar 2027 (expected)