argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG

Rhea-AI Summary

argenx (NASDAQ:ARGX) announced the FDA accepted a supplemental BLA for VYVGART in AChR‑Ab seronegative generalized myasthenia gravis with Priority Review and a PDUFA target action date of May 10, 2026. The sBLA is supported by Phase 3 ADAPT SERON (n=119), which met its primary endpoint (p=0.0068) with a mean MG‑ADL improvement of 3.35 points at week 4 versus placebo. Efficacy signals and MG‑ADL/QMG improvements were seen across MuSK+, LRP4+, and triple seronegative subgroups. VYVGART safety was consistent with its established profile and no new safety concerns were identified.

Positive

• FDA granted Priority Review with PDUFA date May 10, 2026
• Phase 3 ADAPT SERON met primary endpoint (p=0.0068)
• MG-ADL mean improvement of 3.35 points at week 4
• Efficacy observed across MuSK+, LRP4+, and triple seronegative groups
• Safety profile consistent with established VYVGART tolerability; no new signals

Negative

• Phase 3 study sample size was modest (n=119), limiting broader generalizability

News Market Reaction

+1.82%

1 alert

+1.82% News Effect

+$886M Valuation Impact

$49.58B Market Cap

1.1x Rel. Volume

On the day this news was published, ARGX gained 1.82%, reflecting a mild positive market reaction. This price movement added approximately $886M to the company's valuation, bringing the market cap to $49.58B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PDUFA target date: May 10, 2026 Study size: 119 patients Primary endpoint p-value: p=0.0068 +5 more

8 metrics

PDUFA target date May 10, 2026 FDA Priority Review for VYVGART sBLA in AChR-Ab seronegative gMG

Study size 119 patients Phase 3 ADAPT SERON trial in AChR-Ab seronegative gMG

Primary endpoint p-value p=0.0068 MG-ADL total score improvement vs placebo at 4 weeks

MG-ADL improvement 3.35 points Mean change from baseline at week 4 in overall VYVGART-treated population

Part A dosing 4 once-weekly infusions Initial randomized treatment period of ADAPT SERON

Follow-up duration 5 weeks Follow-up period after Part A dosing before primary analysis

Fixed open-label cycles 2 cycles Part B open-label extension with fixed 4-dose cycles

Baseline MG-ADL threshold Score ≥5 Minimum MG-ADL total score required for enrollment

Market Reality Check

Price: $822.69 Vol: Volume 475,724 vs 20-day ...

normal vol

$822.69 Last Close

Volume Volume 475,724 vs 20-day avg 336,090 (relative volume 1.42x) ahead of this FDA update. normal

Technical Price 796 is trading above 200-day MA 701.93 and 14.83% below 52-week high 934.62.

Peers on Argus

ARGX was up 0.95% while key biotech peers (e.g., REGN -5.19%, INSM -4.08%, ALNY ...

ARGX was up 0.95% while key biotech peers (e.g., REGN -5.19%, INSM -4.08%, ALNY -1.83%) traded lower, indicating stock-specific strength tied to the FDA sBLA news rather than a sector-wide move.

Historical Context

5 past events · Latest: Jan 06 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Conference appearance	Neutral	+0.4%	Announcement of participation at J.P. Morgan Healthcare Conference.
Jan 05	Leadership change	Neutral	-4.7%	CEO transition with current COO appointed as new CEO pending approval.
Dec 15	Clinical setback	Negative	-3.1%	Phase 3 UplighTED TED studies discontinued after futility recommendation.
Nov 18	Governance approval	Positive	-0.4%	Extraordinary General Meeting approved remuneration policy with strong support.
Oct 30	Earnings update	Positive	-0.2%	Reported strong Q3 2025 sales, profits, cash, and reiterated high R&D investment.

Pattern Detected

Recent history shows negative clinical or governance events drawing modest selloffs, while strong fundamentals (Q3 2025 results) saw a slightly negative reaction, suggesting occasional divergence between positive fundamentals and short-term price moves.

Recent Company History

Over the last few months, argenx reported strong Q3 2025 financials with $1.13 billion global product net sales and highlighted an sBLA plan for seronegative gMG, then later discontinued its Phase 3 UplighTED TED studies for futility. Governance developments included a CEO transition announced on January 5, 2026 and shareholder approval of the remuneration policy on November 18, 2025. Against this backdrop, the FDA’s acceptance of the VYVGART sBLA with Priority Review represents follow-through on previously outlined regulatory milestones.

Market Pulse Summary

This announcement details FDA acceptance of a supplemental VYVGART filing with Priority Review and a...

Analysis

This announcement details FDA acceptance of a supplemental VYVGART filing with Priority Review and a PDUFA date of May 10, 2026, backed by the Phase 3 ADAPT SERON trial in 119 patients that met its primary endpoint with p=0.0068. The news follows previously disclosed plans to file an sBLA for seronegative gMG, linking regulatory progress to earlier guidance. Investors may focus on the magnitude and durability of the reported 3.35-point MG-ADL benefit and the broader development pipeline when evaluating longer-term implications.

Key Terms

supplemental biologics license application, priority review, pdufa, phase 3, +4 more

8 terms

supplemental biologics license application regulatory

"accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART"

A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.

priority review regulatory

"FDA has accepted for priority review a supplemental Biologics License Application"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

pdufa regulatory

"granted a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

phase 3 medical

"supported by data from the Phase 3 ADAPT SERON study"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized, double-blind, placebo-controlled medical

"is a randomized, double-blind, placebo-controlled, multi-center study"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

open-label extension medical

"Part B is an open-label extension: participants receive 2 fixed cycles"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

mg-adl medical

"improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score"

MG-ADL is a short, self-reported checklist that measures how the neuromuscular disease myasthenia gravis affects basic daily activities like talking, chewing, breathing, and walking. Investors pay attention because changes on this scale are commonly used as a clinical trial endpoint and a practical signal of patient benefit; clearer improvement can boost a treatment’s chances of regulatory approval, uptake by doctors, and commercial value—like a thermometer showing clinical impact.

eq-5d-5l vas medical

"Other scales of evaluation include QMG, MG-QoL 15r, MGC, and EQ-5D-5L VAS"

EQ-5D-5L VAS is a patient-reported health measure combining a five-dimension questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with a visual analogue scale where the patient marks their overall health on a 0–100 line. Investors care because it provides a simple, standardized number showing how a treatment or product affects perceived health, much like a customer satisfaction score, which can influence clinical value, regulatory decisions and reimbursement.

AI-generated analysis. Not financial advice.

January 13, 2026, 7:00 AM CET 

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART® (IV: efgartigimod alfa-fcab) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026.

“Patients living with seronegative gMG continue to face limited treatment options and there remains a significant need to meaningfully improve their lives. The FDA’s acceptance of our sBLA with Priority Review status reflects the potential of VYVGART to address this need,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “This development brings us closer to expanding the use of VYVGART in a broad spectrum of patients with myasthenia gravis. We look forward to continuing our dialogue with the FDA as they review our application.”

The sBLA is supported by data from the Phase 3 ADAPT SERON study, which evaluated the efficacy and safety of VYVGART in adults with AChR-Ab seronegative gMG across all three subtypes – MuSK+, LRP4+, and triple seronegative gMG. The study met its primary endpoint (p-value=0.0068), demonstrating a statistically significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared to placebo after four weeks.

In the overall population, mean change from baseline in patients treated with VYVGART was a clinically meaningful 3.35 point improvement in MG-ADL total score at week 4. Improvements in MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were observed across subsequent treatment cycles in the overall population and in all patient subgroups, including MuSK+, LRP4+, and triple seronegative gMG.

VYVGART was well-tolerated with a safety profile consistent with the established profile of VYVGART in patients with AChR-Ab seropositive gMG and other indications. No new safety concerns were identified.

ADAPT SERON Study Design
The Phase 3 ADAPT SERON study is a randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of efgartigimod in adults with AChR-Ab seronegative gMG (n=119) across North America, Europe, China, and the Middle East. Part A randomized participants (1:1) received 4 once-weekly infusions of efgartigimod IV or placebo, followed by a 5-week follow-up and primary analysis. Part B is an open-label extension: participants receive 2 fixed cycles of 4 once-weekly efgartigimod infusions (4-week interval between cycles); from cycle 3 onward, additional cycles could be started ≥1 week after the last administration of the previous cycle, based on clinical status. The primary endpoint is the MG-ADL total score change from baseline to day 29 in part A. Other scales of evaluation include QMG, MG-QoL 15r, MGC, and EQ-5D-5L VAS. Enrolled participants had a confirmed MG diagnosis by an independent panel of experts, and an MG-ADL total score of 5 or greater. Participants were on a stable dose of at least one gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs. Participants were eligible to enroll in ADAPT SERON if they were AChR-Ab seronegative, which included participants who are MuSK-Ab seropositive, LRP4-Ab seropositive, or triple seronegative.

MG-ADL is a validated measure of disease activity in patients living with myasthenia gravis, which evaluates the functional impact of symptoms on daily activities such as speaking, chewing, swallowing, breathing, and limb strength.

About AChR-Ab Seronegative Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare, chronic, neuromuscular autoimmune disease caused by pathogenic IgGs targeting the neuromuscular junction (NMJ), resulting in impaired neuromuscular transmission and debilitating and potentially life-threatening muscle weakness and chronic fatigue. Approximately 80% of patients with gMG have detectable antibodies against the AChR in sera, and these patients are diagnosed as AChR-Ab seropositive gMG. Approximately 20% of patients with gMG do not have detectable serum antibodies directed against AChR and are referred to as AChR-Ab seronegative gMG. These patients may have detectable autoantibodies targeting other NMJ proteins, such as muscle-specific tyrosine kinase (MuSK) and low-density lipoprotein receptor-related protein 4 (LRP4), or others. Anti-MuSK antibodies are detected in approximately 1-10% of patients with gMG, while anti-LRP4 antibodies are detected in approximately 1-5% of patients with gMG. About 10% of patients do not have any detectable autoantibodies against AChR, MuSK or LRP4. These triple seronegative patients have historically been excluded from studies and have a higher disease burden and unmet medical need compared to patients with detectable autoantibodies. Currently, there are no approved treatments available for patients with anti-LRP4 antibodies or for triple seronegative patients.

Important Safety Information 

What is VYVGART^® (efgartigimod alfa-fcab)? 
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). 
  
IMPORTANT SAFETY INFORMATION 
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. 
  
VYVGART may cause serious side effects, including: 

• Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. 
• Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART.  
• Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. 
  
  

  
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. 
  
Before taking VYVGART, tell your doctor if you: 

• take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, 
• have received or are scheduled to receive a vaccine (immunization), or 
• have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. 
  
  

What are the common side effects of VYVGART? 
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.

These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. 

Please see the full Prescribing Information for VYVGART and talk to your doctor. 

About VYVGART
VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit  www.argenx.com  and follow us on LinkedIn, Instagram, Facebook, and YouTube.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).

Media:
Colin McBean
cmcbean@argenx.com

Investors:
Alexandra Roy
aroy@argenx.com

FORWARD LOOKING STATEMENTS
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “commit,” and “continue,” and include statements argenx makes concerning the potential of VYVGART to meaningfully improve the lives of seronegative gMG patients who continue to face limited treatment options; its goal to expand the use of VYVGART in a broad spectrum of patients with myasthenia gravis; its commitment to improve the lives of people suffering from severe autoimmune diseases; and its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

FAQ

What did argenx (ARGX) announce about VYVGART on January 13, 2026?

argenx announced FDA acceptance of an sBLA for VYVGART in AChR‑Ab seronegative gMG with Priority Review and a PDUFA date of May 10, 2026.

What Phase 3 evidence supports ARGX's sBLA for VYVGART in seronegative gMG?

The Phase 3 ADAPT SERON trial (n=119) met its primary endpoint (p=0.0068) showing a 3.35‑point mean MG‑ADL improvement at week 4 versus placebo.

Did ADAPT SERON show benefits for MuSK+, LRP4+, and triple seronegative patients in ARGX data?

Yes; improvements in MG‑ADL and QMG scores were reported across MuSK+, LRP4+, and triple seronegative subgroups.

What is the PDUFA target action date for ARGX's VYVGART sBLA?

The FDA set a PDUFA target action date of May 10, 2026 for the sBLA.

Were there any new safety concerns reported for VYVGART in ARGX's announcement?

No new safety concerns were identified; the safety profile was consistent with the established VYVGART profile.

How large was the ADAPT SERON study cited by argenx (ARGX)?

ADAPT SERON enrolled 119 adults with AChR‑Ab seronegative generalized myasthenia gravis across multiple regions.