Derek Archila

Gavin Clark-Gartner

Rajan Sharma

Samantha Semenkow

Tazeen Ahmad

Victor Floch

Yaron Werber

Alexander Thompson

Andy Chen

Douglas Tsao

James Gordon

Joel Beatty

Suzanne van Voorthuizen

Vikram Purohit

Yatin Suneja

Akash Tewari

Amy Li

Leland Gershell

Manos Mastorakis

Matthew Phipps

Myles Minter

Xian Deng

Alex Thompson

Brian Conley

Charles Pitman

Charles Pitman-King

Danielle Brill

David Nierengarten

Maddalena Delma Caiati

Mehdi Goudarzi

Nathanael Charoensook

Sean Laaman

Thomas J. Smith

Thomas Smith

- ARGENX's Musk agonist, argenx 119, is advancing into a **registrational study for Congenital Myasthenic Syndromes (CMS)** following positive Phase 1B results demonstrating a **favorable safety profile** and **proof of biology**.  **[1697862_2145841_0]** **[1697862_2145841_12]** **[1697862_2145841_13]** 
- The Phase 1B study in DOK7 CMS patients showed improvements in mobility, with ambulatory patients achieving a median increase of **75 meters** in the six-minute walk test.  **[1697862_2145841_12]** 
- Key upcoming milestones for argenx 119 include **top-line results from an ALS study in the first half of 2026** and the **initiation of an SMA study** (named SPARKLE).  **[1697862_2145841_0]** **[1697862_2145841_21]** 
- Argenx 119 is a core asset in the company's Vision 2030, contributing to the goal of reaching **50,000 patients** across all medicines and **10 labeled indications**.  **[1697862_2145841_0]**

ARGENX Advances argenx 119 into Registrational Study for CMS and Provides Pipeline Updates

- **argenx SE** announced **positive topline results** from the pivotal **ADAPT SERON study** of **VYVGART** in patients with AChR-Ab seronegative generalized myasthenia gravis (gMG) on **August 25, 2025**.  **[1697862_0001104659-25-082118_tm2524211d1_ex99-1.htm:0]** **[1697862_0001104659-25-082118_tm2524211d1_ex99-1.htm:1]** 
- The study **met its primary endpoint** (p-value=**0.0068**), demonstrating a statistically significant and clinically meaningful improvement in MG-ADL total score compared to placebo.  **[1697862_0001104659-25-082118_tm2524211d1_ex99-1.htm:1]** 
- This marks the **first global Phase 3 study** to show clinically meaningful improvements in disease activity across all three seronegative gMG subtypes: MuSK+, LRP4+, and triple seronegative.  **[1697862_0001104659-25-082118_tm2524211d1_ex99-1.htm:1]** 
- Based on these results, argenx plans to submit a **Supplemental Biologics License Application (sBLA)** to the U.S. Food and Drug Administration (FDA) by the **end of 2025** to expand the VYVGART label.  **[1697862_0001104659-25-082118_tm2524211d1_ex99-1.htm:1]**

argenx Reports Positive Topline Results for VYVGART ADAPT SERON Study

ARGENX (ARGX)