ARGENX (ARGX) Company Report

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.
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.
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.
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.
Positive ADAPT SERUM study results support a planned label expansion for VYVGART to include all three seronegative gMG subgroups, indicating a significant commercial opportunity.

Oct 30, 2025, 12:30 PM

Transcript

argenx Reports Record Q3 2025 Financial Results and Pipeline Progress

ARGX

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

argenx reported record total product net sales of $1.13 billion in Q3 2025, marking the first time VYVGART sales surpassed $1 billion in a single quarter, representing 19% quarter-over-quarter growth and 96% year-over-year growth.
The pre-filled syringe (PFS) formulation of VYVGART is a key growth driver, contributing to a 20% quarter-over-quarter increase in U.S. sales and attracting over 260 new prescribers since its launch.
The company has three first-in-class molecules in Phase III development and expects five registration readouts in 2026, including for Ocular gMG, Myositis, TED, MMN, and ITP.
Positive results from the ADAPT SERON study support a planned label expansion for VYVGART to include all three seronegative gMG subgroups.
argenx ended the quarter with a strong cash balance of $4.3 billion and expects full-year 2025 operating expenses to be between $2.6 billion and $2.7 billion.

Oct 30, 2025, 12:30 PM

Transcript

argenx Reports Strong Q3 2025 Financial Results and Pipeline Advancements

ARGX

Earnings

Product Launch

Guidance Update

argenx reported Q3 2025 total product net sales of $1.13 billion, a 96% year-over-year increase, marking the first time VYVGART sales exceeded $1 billion in a single quarter.
The pre-filled syringe (PFS) formulation of VYVGART is a key growth driver, with over 50% of new patients starting on PFS and expanding the prescriber base.
The company plans to file for a label expansion for seronegative generalized Myasthenia Gravis (gMG) following positive ADAPT SERUM study results and anticipates five registration readouts in 2026 across its pipeline.
Strategic pipeline adjustments include advancing efgartigimod into Phase 3 for Graves disease while discontinuing development for empasiprubart in dermatomyositis and efgartigimod in lupus nephritis.
argenx concluded Q3 2025 with a cash balance of $4.3 billion and projects full-year combined R&D and SG&A expenses between $2.6 billion and $2.7 billion.

Oct 30, 2025, 12:30 PM

Transcript

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

ARGX

Earnings

Product Launch

New Projects/Investments

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.
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.
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.
As of September 30, 2025, the company maintained a strong financial position with $4.3 billion in cash, cash equivalents, and current financial assets.

Oct 30, 2025, 12:04 PM

6-K

ARGENX SE Presents Positive VYVGART Data for Myasthenia Gravis

ARGX

New Projects/Investments

Revenue Acceleration/Inflection

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.
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). argenx plans to seek expansion of the VYVGART label to include this patient group.
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.
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.

Oct 29, 2025, 3:11 PM

6-K

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

ARGX

New Projects/Investments

Guidance Update

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.
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.
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).
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.

Sep 16, 2025, 6:00 PM

Transcript

argenx Reports Positive Topline Results for VYVGART ADAPT SERON Study

ARGX

Product Launch

New Projects/Investments

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.
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.
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.
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.

Aug 25, 2025, 12:00 AM

6-K

Earnings Transcripts

Quarterly earnings call transcripts for ARGENX.

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