Argenx digests phase 2 celiac win for $2.2B drug, preps pivotal run
Argenx shares plunged after the company discontinued a late-stage study of its drug Vyvgart for Sjögren's disease following a futility flag showing the treatment failed to outperform a placebo. Simultaneously, the company reported positive topline results from a Phase 2 trial of its experimental CD122 inhibitor FB102 in celiac disease, where the drug met its primary endpoint by preventing gluten-induced intestinal damage in a 126-patient study. Argenx now plans to advance the $2.2B drug FB102 into Phase 3 development despite the setback for its autoimmune disease candidate.
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- ✓ Argenx discontinued its Vyvgart study in Sjögren's disease after the trial failed to outperform placebo.
- ✓ FB102 met its primary endpoint in a 126-patient Phase 2 celiac disease study.
- ✓ Argenx plans to advance FB102 into Phase 3 development.
- ✓ Argenx shares plunged following the autoimmune-disease trial halt and study setback.
What changed
Argenx halted a late-stage study of Vyvgart in Sjögren's disease while reporting positive Phase 2 results for its celiac disease drug FB102.
Live updates
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Argenx Shares Plunge Following Sjögren's Trial Halt and Celiac Win
Argenx shares plunged after the company discontinued a late-stage study of its drug Vyvgart for Sjögren's disease following a futility flag showing the treatment failed to outperform a placebo. Simultaneously, the company reported positive topline results from a Phase 2 trial of its experimental CD122 inhibitor FB102 in celiac disease, where the drug met its primary endpoint by preventing gluten-induced intestinal damage in a 126-patient study. Argenx now plans to advance the $2.2B drug FB102 into Phase 3 development despite the setback for its autoimmune disease candidate.
Why it matters
The contrasting trial outcomes present a mixed developmental outlook for Argenx as it balances pipeline advancements against unexpected late-stage clinical failures. The failure of Vyvgart in Sjögren's disease marks a significant setback for the drug in expanding its autoimmune indications. Conversely, the success of FB102 establishes the first Phase 2 evidence that blocking CD122 can prevent intestinal damage in celiac disease patients.
What is confirmed
- Argenx discontinued its Vyvgart study in Sjögren's disease after the trial failed to outperform placebo.
- FB102 met its primary endpoint in a 126-patient Phase 2 celiac disease study.
- Argenx plans to advance FB102 into Phase 3 development.
- Argenx shares plunged following the autoimmune-disease trial halt and study setback.
What to watch next
- Progression of FB102 into Phase 3 clinical development
- Further data readouts regarding the FB102 celiac disease program
confidence 100%Sources used for this update (11)
- Fierce Biotech — Argenx digests phase 2 celiac win for $2.2B drug, preps pivotal run
- WSJ — Argenx Shares Plunge After Autoimmune-Disease Trial Halt
- STAT — Argenx sees unusual setback with failure of late-stage study of drug for autoimmune disease
- Yahoo Finance — Why Is ARGX Stock Plunging Today?
- Reuters — Argenx discontinues Vyvgart study in Sjögren's disease, shares tumble
- Fierce Pharma — Argenx walks away from Vyvgart Sjögren's disease trial after futility flag
- argenx.com — argenx Announces Positive Topline Results from Phase 2 Study ...
- theclinicaltimes.com — Argenx reports celiac trial win and Sjögren's study setback
- finance.yahoo.com — argenx Announces Positive Topline Results from Phase 2 Study ...
- finance.yahoo.com — argenx Reports Positive Phase 2 Celiac Disease Trial Results ...
- allsci.com — Argenx's FB102 meets Phase II celiac disease endpoint ...
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