---
title: "Argenx Sjögren’s Phase 3 failure and FDA safety flag for evenamide in schizophrenia trials"
id: "stat-news-2-stat-pharmalittle-we-re-reading-about-a-setback-for-argenx-lilly-suits-over"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-2-stat-pharmalittle-we-re-reading-about-a-setback-for-argenx-lilly-suits-over"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/pharmalot/2026/10/09/pharmalittle-were-reading-about-a-setback-for-argenx-lilly-suits-over-copycat-versions-of-an-obesity-drug-and-more/?utm_campaign=rss"
published_at: "2026-10-09T13:17:20.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Argenx Sjögren’s Phase 3 failure and FDA safety flag for evenamide in schizophrenia trials
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-2-stat-pharmalittle-we-re-reading-about-a-setback-for-argenx-lilly-suits-over
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/pharmalot/2026/10/09/pharmalittle-were-reading-about-a-setback-for-argenx-lilly-suits-over-copycat-versions-of-an-obesity-drug-and-more/?utm_campaign=rss)
- **Published At:** 2026-10-09T13:17:20.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Argenx announced that its monoclonal antibody therapy **Vyvgart** did not beat placebo in a Phase 3 trial for **Sjögren’s disease**, an autoimmune disorder, representing a notable clinical setback for the company. - The Sjögren’s trial was stopped early after an independent data monitoring committee concluded the trial would not meet its primary endpoint. - Analysts at William Blair had previously labeled the Sjögren’s program high risk and estimated potential peak sales of $1.4 billion for Vyvgart in the indication; the source notes high placebo response rates are common in Sjögren’s trials and contributed to the risk. - The U.S. Food and Drug Administration raised a potential safety concern after four deaths were reported among patients with treatment-resistant schizophrenia who received the investigational drug **evenamide** in clinical studies. - The FDA previously halted enrollment in a Phase 3 trial of evenamide in April after a sudden death; that enrollment hold remains in place at U.S. study centers, while enrollment continues at sites in other countries and additional sites are being added. - The regulator’s concern centers on the possibility that some **sodium channel blockers** can provoke arrhythmias that may lead to severe cardiovascular events or seizures; evenamide’s profile prompted this safety review. - The reporting is by Ed Silverman in Pharmalittle on Oct. 9, 2026; portions of the story are marked STAT+ exclusive and require subscription for full access. - The article links to STAT reporting on Argenx and to MedPage Today coverage regarding the FDA action on evenamide.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) # Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more ## The FDA flagged a potential safety signal after four patient deaths in a trial testing a schizophrenia drug * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * [Save this story for later](https://www.statnews.com/my-account/saved/) * [Share this article](https://www.statnews.com/pharmalot/2026/10/09/pharmalittle-were-reading-about-a-setback-for-argenx-lilly-suits-over-copycat-versions-of-an-obesity-drug-and-more/?utm_campaign=rss) ![an anthropomorphized red and blue pill illustrated in the style of the famous american gothic painting](https://www.statnews.com/wp-content/uploads/2015/11/PHARMALOT_LITTLE-copy-645x645.jpg) Alex Hogan/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) By [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) Oct. 9, 2026 Pharmalot Columnist, Senior Writer ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) 1. [](https://www.linkedin.com/in/edsilverman/ "Linkedin") 2. [](https://x.com/Pharmalot "X") ed.silverman@statnews.com Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots and celebrate the turning of another page on the calendar with our remaining Pharmalot ancestor. We also hope to hold another listening party, where the rotation will likely include [this](https://youtu.be/4JRfe_3MEaU?si=68Qkqir-l5cq66pq), [this](https://youtu.be/h3dKBQQsjUM?si=Qy55CN_DRmn7XKrc), [this](https://youtu.be/ltBFHo6sUpA?si=z86HNK3Vh77YSRSQ), [this](https://youtu.be/UWTf1zGTHqM?si=wSkMFVxOnXLVwTsB) and [this](https://youtu.be/IyqIdF3RyKU?si=GmOtT8gnsjoUxBzE). And what about you? This is the time of year when apples and pumpkins grow lonely, waiting for someone to take them to a nice home. So perhaps a drive in the country is in order. This may also be an opportunity to simply enjoy the great outdoors, given the lovely change of scenery that is taking place. Or you could keep busy by strolling city streets and watching life go by. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon… **Argenx disclosed that its blockbuster drug Vyvgart failed to outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder, marking an unusual setback for the company,** [STAT](https://www.statnews.com/2026/10/08/argenx-autoimmune-disease-study-sjogrens/) says. Argenx has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs based on market cap. William Blair analysts had projected $1.4 billion in peak sales from Vyvgart in Sjögren’s disease but described the trial as high risk, in part because Sjögren’s patients often have high placebo responses. The trial was supposed to be completed next year, but it was stopped early after a data monitoring committee determined the primary endpoint would not be met. Advertisement **The Food and Drug Administration flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials** , [MedPage Today](https://www.medpagetoday.com/psychiatry/schizophrenia/123330) informs us. In April, the agency halted patient enrollment in a Phase 3 trial for the Newron Pharmaceuticals medicine after the sudden death of a participant. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added. The FDA concern relates to the risk that some sodium channel blockers may trigger arrhythmias that can lead to serious cardiovascular events or seizures. [![STAT+](https://www.statnews.com/wp-content/themes/stat/images/stat-plus-logo.svg)](https://www.statnews.com/stat-plus/) To read the rest of this story subscribe to STAT+. 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