Health
STAT+: Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more
Publication: STAT
Author: Ed Silverman
Source published: 09/10/2026, 13:17:20 UTC
Briefing created: 09/10/2026, 13:40:25 UTC
Based on a feed excerpt; full article content has not been acquired. Source evidence retrieved 09/10/2026, 13:21:24 UTC.
Briefings
Argenx's blockbuster drug Vyvgart failed to meet primary endpoints in a Phase 3 trial for Sjögren’s disease, causing the company to halt enrollment and face regulatory scrutiny. The trial was stopped early due to a lack of efficacy, with analysts projecting $1.4 billion in peak sales that were not realized. While the FDA flagged safety concerns regarding arrhythmias, the specific mechanism linking the drug to these events remains unclear. This setback represents a significant shift for Argenx, which had previously led the market in autoimmune disorders.
Key points
- Argenx halted enrollment in its Phase 3 trial for Vyvgart due to the drug failing to meet primary endpoints in patients with Sjögren’s disease.
- William Blair analysts had projected $1.4 billion in peak sales from Vyvgart in Sjögren’s disease but the trial was stopped early.
Context and limitations
The evidence covers only the Phase 3 trial results for Sjögren’s disease and mentions a separate FDA safety signal for a different drug in schizophrenia trials. Specific details on the exact mechanism of arrhythmia risk and the full scope of the safety concern are not provided.
Generated by Bittrees-hosted qwen35-2b sha256:aaf42c8b7c3c on 09/10/2026, 13:40:25 UTC. Based on publisher-provided feed evidence; may not cover the full original article. Check the source for details.
View archived briefing on IPFS
bafybeicm4ampn7u42kdwlsqriuffnf5tc7jblr7g2syaepmeal2sol6xfe