Phase 3 ALKIVIA met primary endpoint in autoimmune myositis (p=0.0011)
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- argenx SE ARGX
- 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
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.
More details
- 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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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
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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.
More details
- 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
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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.
More details
- 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
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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.
More details
- 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
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.
More details
- 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