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 reported **Q3 2025 total product net sales of $1.13 billion**, marking the first time VYVGART sales surpassed **$1 billion** in a single quarter, representing **96% year-over-year growth**.  **[0001697862_2216040_4]** 
- U.S. product net sales for VYVGART reached **$964 million**, growing **20% quarter-over-quarter**, primarily driven by the successful launch of the pre-filled syringe (PFS) and continued momentum in gMG and CIDP.  **[0001697862_2216040_4]** **[0001697862_2216040_5]** 
- The company achieved an **operating profit of $346 million** and a **profit after tax of $344 million** for the quarter, with a cash balance of **$4.3 billion** at quarter-end.  **[0001697862_2216040_4]** 
- argenx is expanding its pipeline, with **three first-in-class molecules in Phase 3 development** and plans for **four new molecules in Phase 1 development** by year-end 2025.  **[0001697862_2216040_1]** **[0001697862_2216040_3]** 
- Positive ADAPT SERUM study results support a planned label expansion for VYVGART to include all three seronegative gMG subgroups, indicating a significant commercial opportunity.  **[0001697862_2216040_1]** **[0001697862_2216040_11]**

argenx Announces Strong Q3 2025 Financial Results with VYVGART Sales Exceeding $1 Billion

- argenx SE reported strong financial results for Q3 2025, with **$1.13 billion** in global product net sales and a basic profit per share of **$5.61**.  **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:0]** **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:2]** 
- The company is advancing its key product, VYVGART, with the SC prefilled syringe approved in Japan in September 2025 and a Supplemental Biologics License Application (sBLA) for seronegative gMG on track for U.S. FDA filing by year-end 2025.  **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:0]** 
- argenx anticipates five registrational study readouts in 2026, including topline results for ocular MG in the first half of 2026 and primary ITP in the second half of 2026.  **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:0]** 
- As of September 30, 2025, the company maintained a strong financial position with **$4.3 billion** in cash, cash equivalents, and current financial assets.  **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:4]** **[1697862_0001697862-25-000059_a02earningspressreleaseq3.htm:9]**

argenx SE Reports Strong Q3 2025 Financial Results and Provides Business Update

- argenx SE presented **new data** at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM) and Myasthenia Gravis Foundation of America (MGFA) Scientific Session, highlighting the efficacy and safety of **VYVGART** across generalized myasthenia gravis (gMG) patient populations.  **[1697862_0001104659-25-103621_tm2529569d1_ex99-1.htm:0]** 
- The Phase 3 **ADAPT SERON study met its primary endpoint**, demonstrating a statistically significant improvement in MG-ADL total score for **AChR-Ab seronegative gMG patients** treated with VYVGART (p-value=0.0068).  **[1697862_0001104659-25-103621_tm2529569d1_ex99-1.htm:0]**  argenx plans to seek **expansion of the VYVGART label** to include this patient group.  **[1697862_0001104659-25-103621_tm2529569d1_ex99-1.htm:1]** 
- Final **ADAPT SC+ results** showed that approximately **59.2% of AChR-Ab+ participants achieved minimal symptom expression (MSE)** at least once, with **88.1% sustaining MSE for at least 4 weeks**.  **[1697862_0001104659-25-103621_tm2529569d1_ex99-1.htm:1]** 
- Real-world data from an IQVIA study indicated that **72.5% of patients** treated with VYVGART meaningfully **reduced glucocorticoid use**, with the average daily dose decreasing by **more than 50%** (from 16.6 to 7.5 mg/day) at 18 months.  **[1697862_0001104659-25-103621_tm2529569d1_ex99-1.htm:1]**

ARGENX SE Presents Positive VYVGART Data for Myasthenia Gravis

- 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)