ARGX · Company research

argenx SE

9 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

MilestoneARGXargenx2026

Adimanebart (ARGX-119) registrational study start in congenital myasthenic syndromes, expected during 2026 (no exact date yet). A company milestone for argenx (adimanebart (ARGX-119) for congenital myasthenic syndromes): a step in the program rather than a decision or a data readout.

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Entry

Adimanebart (ARGX-119) registrational study start in congenital myasthenic syndromes · Company milestone

Drug

adimanebart (ARGX-119)

For

congenital myasthenic syndromes

Stage

Registrational · a study designed to support approval

When

2026 · the company gave a window, not a day

Source note

Q2 2026 PR (Jul 23, 2026) guides 2026 start; the Q1 2026 PR had said 'CMS registrational study on track to start in third quarter of 2026'. Using the less precise, more recent guidance.

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

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MilestoneARGXargenx2026

ARGX-121 (anti-IgA) Phase 2 start in IgA nephropathy, expected during 2026 (no exact date yet). A company milestone for argenx (ARGX-121 for IgA nephropathy): a step in the program rather than a decision or a data readout.

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Entry

ARGX-121 (anti-IgA) Phase 2 start in IgA nephropathy · Company milestone

Drug

ARGX-121

For

IgA nephropathy

Stage

Phase 2 · the stage that tests whether the drug actually works

When

2026 · the company gave a window, not a day

Source note

argenx H1 2026 results (Jul 23, 2026) reiterated 2026 Phase 2 start for ARGX-121 in IgAN.

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneARGXargenx2026

ARGX-118 and ARGX-125 to enter Phase 1 in 2026, expected during 2026 (no exact date yet). A company milestone for argenx (ARGX-118 / ARGX-125 for undisclosed): a step in the program rather than a decision or a data readout.

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Entry

ARGX-118 and ARGX-125 to enter Phase 1 in 2026 · Company milestone

Drug

ARGX-118 / ARGX-125

For

undisclosed

Stage

Phase 1 · an early safety study in a small group of people

When

2026 · the company gave a window, not a day

Source note

argenx H1 2026 results (Jul 23, 2026): two new first-in-class molecules on track for Phase 1 entry in 2026 (TSP-101 Phase 1 already ongoing).

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsARGXargenxQ4 2026

argenx expects to report results from its Registrational (EMPASSION) study of Empasiprubart (ARGX-117) for Multifocal motor neuropathy (MMN) in Q4 2026 (Oct–Dec) (no exact date yet). Registrational (EMPASSION) is a study designed to support approval.

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Entry

EMPASSION registrational topline: empasiprubart in multifocal motor neuropathy · Clinical trial results (readout / topline data)

Drug

Empasiprubart (ARGX-117)

For

Multifocal motor neuropathy (MMN)

Stage

Registrational (EMPASSION) · a study designed to support approval

When

Q4 2026 · the company gave a window, not a day

Source note

H1 2026 results PR: 'Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026.'

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneARGXargenxQ4 2026

ARGX-124 (next-gen FcRn) to complete Phase 1 evaluation by end of 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for argenx (ARGX-124 for FcRn (undisclosed autoimmune)): a step in the program rather than a decision or a data readout.

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Entry

ARGX-124 (next-gen FcRn) to complete Phase 1 evaluation by end of 2026 · Company milestone

Drug

ARGX-124

For

FcRn (undisclosed autoimmune)

Stage

Phase 1 · an early safety study in a small group of people

When

Q4 2026 · the company gave a window, not a day

Source note

argenx H1 2026 results PR (Jul 23, 2026) guides ARGX-124 Phase 1 completion by year-end 2026; ARGX-213 described as Phase 3 ready. Dated Q4 per 'by end of 2026'.

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsARGXargenxH1 2027

argenx expects to report results from its Registrational (ADVANCE-NEXT) study of Efgartigimod (Vyvgart) for Primary immune thrombocytopenia in the first half of 2027 (no exact date yet). Registrational (ADVANCE-NEXT) is a study designed to support approval.

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Entry

ADVANCE-NEXT registrational topline: efgartigimod in primary ITP · Clinical trial results (readout / topline data)

Drug

Efgartigimod (Vyvgart)

For

Primary immune thrombocytopenia

Stage

Registrational (ADVANCE-NEXT) · a study designed to support approval

When

H1 2027 · the company gave a window, not a day

Source note

H1 2026 results PR: 'Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027.'

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneARGXargenx2027

VYVGART SC autoinjector launch for all approved indications, expected during 2027 (no exact date yet). A company milestone for argenx (efgartigimod (VYVGART Hytrulo autoinjector) for gMG / CIDP): a step in the program rather than a decision or a data readout.

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Entry

VYVGART SC autoinjector launch for all approved indications · Company milestone

Drug

efgartigimod (VYVGART Hytrulo autoinjector)

For

gMG / CIDP

Stage

Commercial

When

2027 · the company gave a window, not a day

Source note

argenx H1 2026 results (Jul 23, 2026) positions the SC autoinjector launch in 2027; no specific half-year given.

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsARGXargenxH2 2027

argenx expects to report results from its Registrational (UNITY) study of Efgartigimod (Vyvgart) for Sjogren's disease in the second half of 2027 (no exact date yet). Registrational (UNITY) is a study designed to support approval.

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Entry

UNITY registrational topline: efgartigimod in Sjogren's disease · Clinical trial results (readout / topline data)

Drug

Efgartigimod (Vyvgart)

For

Sjogren's disease

Stage

Registrational (UNITY) · a study designed to support approval

When

H2 2027 · the company gave a window, not a day

Source note

H1 2026 results PR: 'Topline results from registrational UNITY study (Sjogren's disease) expected in second half of 2027.'

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsARGXargenxH2 2027

argenx expects to report results from its Registrational (EMVIGORATE, EMNERGIZE) study of Empasiprubart (ARGX-117) for Chronic inflammatory demyelinating polyneuropathy (CIDP) in the second half of 2027 (no exact date yet). Registrational (EMVIGORATE, EMNERGIZE) is a study designed to support approval.

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Entry

EMVIGORATE and EMNERGIZE registrational topline: empasiprubart in CIDP · Clinical trial results (readout / topline data)

Drug

Empasiprubart (ARGX-117)

For

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Stage

Registrational (EMVIGORATE, EMNERGIZE) · a study designed to support approval

When

H2 2027 · the company gave a window, not a day

Source note

H1 2026 results PR: 'Topline results from registrational EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027.'

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

Trial resultsARGXargenxAug 17, 2026

argenx reported results from its Phase 3 study of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Autoimmune myositis (IMNM, dermatomyositis, polymyositis) on Aug 17, 2026. The study met its main goal.

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Entry

Phase 3 ALKIVIA met primary endpoint in autoimmune myositis (p=0.0011) · Clinical trial results (readout / topline data)

Drug

VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

For

Autoimmune myositis (IMNM, dermatomyositis, polymyositis)

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 17, 2026

Source note

ALKIVIA hit its primary endpoint with a 15.4-point greater mean Total Improvement Score at Week 52 versus placebo (47.95 vs 32.56) in the combined IMNM and dermatomyositis population. It is the first Phase 3 to show significant benefit in IMNM, which has no approved therapy.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsARGXargenxQ3 2026

argenx reported results from its Phase 3 study of Efgartigimod (Vyvgart) for Idiopathic inflammatory myopathies (myositis) in Q3 2026 (Jul–Sep). The linked source has what the numbers showed.

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Entry

ALKIVIA registrational topline: efgartigimod in myositis · Clinical trial results (readout / topline data)

Drug

Efgartigimod (Vyvgart)

For

Idiopathic inflammatory myopathies (myositis)

Stage

Phase 3 · the last stage before a drug can be approved

When

Q3 2026 · the company gave a window, not a day

Source note

H1 2026 results PR (July 23, 2026): 'Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026.'

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Source: argenx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceARGXargenxJun 3, 2026

argenx presented data on VYVGART / VYVGART Hytrulo (efgartigimod) for Autoimmune myositis and Sjogren's disease at a medical meeting on Jun 3, 2026. The linked source has the details.

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Entry

EULAR 2026: long-term efgartigimod data in myositis and Sjogren's disease · Data presented at a medical meeting

Drug

VYVGART / VYVGART Hytrulo (efgartigimod)

For

Autoimmune myositis and Sjogren's disease

Stage

Phase 2/3 · a combined mid- to late-stage study

When

Jun 3, 2026

Source note

argenx presented long-term efgartigimod data across autoimmune rheumatic diseases at EULAR 2026, including maintained response in Sjogren's disease after switching to biweekly dosing and a cross-indication safety analysis.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

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ApprovalARGXargenxMay 8, 2026

The FDA approved argenx’s VYVGART / VYVGART Hytrulo (efgartigimod) for Generalized myasthenia gravis (all serotypes) on May 8, 2026. The company can now sell it in that market.

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Entry

FDA approves VYVGART label expansion to all adult gMG serotypes · Regulatory approval

Drug

VYVGART / VYVGART Hytrulo (efgartigimod)

For

Generalized myasthenia gravis (all serotypes)

Stage

Phase 3 · the last stage before a drug can be approved

When

May 8, 2026

Source note

FDA approved the sBLA expanding VYVGART and VYVGART Hytrulo to all adult gMG serotypes including MuSK-Ab, LRP4-Ab and triple seronegative patients, two days ahead of the May 10, 2026 target action date. The approval rests on the Phase 3 ADAPT SERON study.

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ClinicalTrials.gov ↗ — trials of this drug
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceARGXargenxApr 18, 2026

argenx presented data on VYVGART / VYVGART Hytrulo (efgartigimod) for Ocular and generalized myasthenia gravis, CIDP at a medical meeting on Apr 18, 2026. The linked source has the details.

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Entry

AAN 2026: ADAPT OCULUS shows VYVGART benefit in ocular myasthenia gravis · Data presented at a medical meeting

Drug

VYVGART / VYVGART Hytrulo (efgartigimod)

For

Ocular and generalized myasthenia gravis, CIDP

Stage

Phase 3 · the last stage before a drug can be approved

When

Apr 18, 2026

Source note

At AAN 2026 argenx presented Phase 3 ADAPT OCULUS, ADAPT SERON and ADAPT Jr results positioning VYVGART as effective across MG subtypes, alongside an ADHERE post-hoc in which 87.5% of treatment-naive CIDP patients achieved early benefit.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceARGXargenxMar 6, 2026

argenx presented data on VYVGART / VYVGART Hytrulo (efgartigimod) for Myasthenia gravis and CIDP at a medical meeting on Mar 6, 2026. The linked source has the details.

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Entry

argenx to present Phase 3 ADAPT OCULUS and SERON data at AAN 2026 · Data presented at a medical meeting

Drug

VYVGART / VYVGART Hytrulo (efgartigimod)

For

Myasthenia gravis and CIDP

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 6, 2026

Source note

argenx previewed its AAN 2026 lineup, headlined by positive Phase 3 ADAPT OCULUS results in ocular myasthenia gravis and additional ADAPT SERON data in seronegative gMG, plus CIDP post-hoc and biomarker analyses.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
ARGX headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Things of Interest

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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