- Halozyme's Q1 Earnings & Revenues Beat Estimates, Stock Up
May 12, 2026
Halozyme Therapeutics HALO reported first-quarter 2026 adjusted earnings of $1.60 per share, which beat the Zacks Consensus Estimate of $1.54. Earnings rose 44.1% year over year.
Total revenues in the first quarter increased 42% year over year to $376.7 million. Revenues too surpassed the Zacks Consensus Estimate of $358 million.
The top-line growth was primarily driven by an increase in product sales as well as higher royalty payments. HALO received royalty payments from Roche RHHBY for Phesgo and J&J JNJ for subcutaneous Darzalex (daratumumab), as well as argenx ARGX for Vyvgart Hytrulo.
Several companies use HALO’s Enhanze technology to develop a subcutaneous formulation of their currently marketed drugs. Halozyme now has several marketed partnered drugs based on this technology, including the subcutaneous (SC) formulation of J&J’s Darzalex, Roche’s Phesgo and argenx’s Vyvgart Hytrulo.
Shares of Halozyme were up 3.6% in after-hours trading on Monday owing to the better-than-expected results.
However, the stock has lost 1.3% year to date compared with the industry’s 2.6% decline.Zacks Investment Research
Image Source: Zacks Investment Research
HALO's Q1 Earnings in Detail
Halozyme’s top line comprises product sales, royalties and revenues under collaborative agreements.
Royalty revenues totaled $240.7 million in the first quarter, up 43% from the year-ago quarter’s level. This was mainly due to the robust demand for RHHBY's Phesgo, JNJ's subcutaneous Darzalex and ARGX's Vyvgart Hytrulo, on which it earns royalties.
Royalty revenues, however, missed our model estimate of $256.6 million.
Product sales were $130.4 million in the first quarter, up 67.2% from the year-ago quarter’s level. HALO has two commercial proprietary products, Hylenex and Xyosted, with the latter acquired from Antares Pharma in 2022.
Product sales beat our model estimate of $91.1 million.
Revenues under collaborative agreements were $5.6 million in the reported quarter, down almost 70% year over year.
Adjusted EBITDA was $229.5 million in the reported quarter, compared with $162 million in the year-ago quarter.
Halozyme had cash, cash equivalents and marketable securities of $320.9 million as of March 31, 2026, compared with $145.4 million as of Dec. 31, 2025.
HALO's 2026 Guidance
Halozyme reiterated its total revenue guidance for 2026, which it had provided earlier this year.
The company continues to expect total revenues in the range of $1.71 billion to $1.81 billion for 2026, implying year-over-year growth of 22% to 30%. Total revenues are expected to grow due to increased royalty revenues and higher product sales from API.
Story Continues
Royalty revenues are anticipated in the range of $1.13-$1.17 billion, implying year-over-year growth of 30% to 35%.
Adjusted EBITDA is expected in the band of $1.13-$1.21 billion, implying a year-over-year surge of 71% to 83%.
Adjusted earnings are expected in the range of $7.75-$8.25 per share in 2026, implying growth of 87% to 99% year over year.
HALO’s adjusted earnings per share guidance included the impact of approximately $60 million related to the recent Hypercon and Surf Bio investment. The adjusted earnings per share guidance does not consider the impact of potential future share repurchases.
Halozyme Therapeutics, Inc. Price, Consensus and EPS SurpriseHalozyme Therapeutics, Inc. Price, Consensus and EPS Surprise
Halozyme Therapeutics, Inc. price-consensus-eps-surprise-chart | Halozyme Therapeutics, Inc. Quote
HALO’s Zacks Rank
Halozyme currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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- argenx SE (ARGX) Presents at Bank of America Global Healthcare Conference 2026 Transcript
May 12, 2026 · seekingalpha.com
argenx SE (ARGX) Presents at Bank of America Global Healthcare Conference 2026 Transcript
- AbCellera Biologics Q1 Earnings Call Highlights
May 11, 2026
AbCellera Biologics logo
Key Points
Interested in AbCellera Biologics Inc.? Here are five stocks we like better. AbCellera’s lead program ABCL635 advanced with interim Phase 1 data showing it was generally well-tolerated, with no serious adverse events or liver toxicity, and the company said it remains on track for Phase 2 top-line data in Q3 2026. The company highlighted target-engagement evidence for ABCL635, including sustained, dose-dependent testosterone suppression, which management said supports the idea that the antibody can reach its intended NK3R target in the hypothalamus. AbCellera ended Q1 with about CAD 655 million in available liquidity including government funding, while narrowing its quarterly net loss slightly year over year as it continues to shift resources toward its internal pipeline.
Argenx's 28% Surge & Promising Product Propel Investor Confidence
AbCellera Biologics (NASDAQ:ABCL) said its first quarter of 2026 was marked by progress in its internal drug pipeline, including interim Phase 1 data for its lead program, ABCL635, and continued preparation for multiple clinical catalysts expected over the next two years.
President and CEO Dr. Carl Hansen said the company entered 2026 in a “strong financial position,” with major platform and infrastructure projects “substantially complete” and its internal pipeline positioned for several upcoming readouts. The company’s priorities for the year include top-line data for ABCL635 and ABCL575, advancing ABCL688 and ABCL386 through IND-enabling activities, and adding at least one new development candidate.
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The most closely watched milestone is the Phase 2 readout for ABCL635, which Hansen said remains expected in the third quarter of 2026. The program is being developed as a potential first-in-class antibody medicine for the non-hormonal treatment of moderate to severe vasomotor symptoms, or hot flashes, associated with menopause.
ABCL635 Moves Forward After Interim Phase 1 Data
Chief Medical Officer Dr. Sarah Noonberg presented interim Phase 1 data for ABCL635, an antibody targeting NK3R, a GPCR target that has been clinically validated in hot flashes. The Phase 1 trial was a randomized, double-blind, placebo-controlled study in healthy volunteers, including a single ascending dose portion and a multiple ascending dose portion.
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Noonberg said unblinded data from the single ascending dose portion showed that ABCL635 was “generally well-tolerated.” Across cohorts, there were no reports of serious adverse events, severe adverse events, adverse events leading to discontinuation, or liver toxicity. She said the absence of liver-related adverse events was “an important differentiator” for the program.
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The overall incidence of any adverse event was 50% in both the ABCL635 treatment group and the pooled placebo group. Most reported adverse events were grade 1. Noonberg said the only potential signal was self-limiting headache clustered in the 900 mg cohort, generally mild and resolving without complication. No headache adverse events were reported in the 600 mg cohort.
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ABCL635 also showed pharmacokinetic characteristics that the company believes support monthly subcutaneous dosing. Noonberg said the drug exhibited “favorable linear pharmacokinetics” across doses, with low variability and an estimated half-life of about 24 days.
Company Highlights Target Engagement Data
A key question for the program was whether an antibody could access NK3R in the hypothalamus. Noonberg said testosterone levels in men were used as a surrogate biomarker for NK3R target engagement, based on prior validation in the early development of the small molecule fezolinetant.
According to Noonberg, a single dose of ABCL635 produced sustained, dose-dependent testosterone suppression in men over a four-week period, with recovery to baseline by eight to 12 weeks. She said doses of 300 mg, 600 mg and 900 mg were associated with sustained testosterone reductions of 50% to more than 75% for several weeks. The company also observed dose-dependent suppression of FSH and LH at those doses.
“Based on these pharmacodynamic data, we feel confident that ABCL635 is able to reach the KNDy neurons in the infundibular nucleus, and we have addressed an important scientific risk for this program,” Noonberg said.
The ongoing Phase 2 portion is a randomized, double-blind, placebo-controlled, multicenter study of approximately 80 patients with moderate to severe vasomotor symptoms. Participants receive a single 600 mg dose of ABCL635 or placebo. The primary efficacy endpoint is at four weeks, with patients followed for an additional eight weeks to evaluate drug concentration and efficacy relationships.
Noonberg said the Phase 2 study is enrolling well and remains on track for top-line efficacy and safety data in the third quarter. If successful, the company plans to discuss a late-stage development program for menopause-associated vasomotor symptoms and evaluate potential use in hot flashes associated with breast and prostate cancer treatments.
Additional Pipeline Readouts Expected
Hansen said AbCellera expects a top-line Phase 1 readout for ABCL575 in the fourth quarter of 2026. The company describes ABCL575 as a potential best-in-class OX40L antagonist. Hansen reiterated that AbCellera’s plan is to complete Phase 1 studies before seeking a partner and that the company does not currently intend to develop the program beyond Phase 1 on its own.
Beyond ABCL635 and ABCL575, Hansen said the company is on track to have up to three additional clinical-stage programs by the end of 2027. That includes undisclosed programs ABCL688 and ABCL386, which he said are expected to begin clinical development in Phase 1/2 studies with a path to early proof of concept in patients. The company also aims to select a fifth development candidate in the first half of 2026.
First-Quarter Financial Results
Chief Financial Officer Andrew Booth said AbCellera ended the quarter with approximately CAD 531 million in cash equivalents and marketable securities, down CAD 30 million from the prior quarter. He said the company has roughly CAD 125 million in available committed government funding, bringing available liquidity to approximately CAD 655 million.
Revenue for the quarter was about CAD 8 million, compared with approximately CAD 4 million in the same quarter of 2025, consisting mostly of research fees. Booth said research fee revenue is expected to trend lower as the company focuses on its internal pipeline.
Research and development expenses were approximately $47 million, about $4 million higher than a year earlier, reflecting investment in internal programs. Sales, general and administrative expenses were about $12 million, compared with roughly $19 million last year. Booth said the more than 35% decrease was related to the conclusion of intellectual property litigation and team changes tied to the internal pipeline focus.
AbCellera reported a net loss of roughly $43 million for the first quarter, compared with a loss of about $46 million a year earlier. The loss was $0.14 per share on a basic and diluted basis. Booth said the company continues to believe it has sufficient liquidity to fund at least the next three years of pipeline investments.
Management Addresses Development Questions
During the question-and-answer session, analysts focused heavily on the interpretation of ABCL635’s testosterone suppression data and how it may translate into efficacy for patients with hot flashes. Hansen cautioned that the biomarker is not a direct measure of efficacy, saying the Phase 2 trial is designed to answer that question.
Hansen said the company’s base commercial profile for ABCL635 would be a product with efficacy comparable to small molecules, a cleaner safety profile without liver monitoring and once-monthly subcutaneous dosing. Noonberg added that the 12-week follow-up in Phase 2 should help the company build a pharmacokinetic and pharmacodynamic model to support discussions with regulators about late-stage development.
About AbCellera Biologics (NASDAQ:ABCL)
AbCellera Biologics Inc (NASDAQ: ABCL) is a biotechnology company specializing in the discovery and development of therapeutic antibodies. The company's technology platform integrates single-cell screening, microfluidics, high-throughput sequencing and artificial intelligence to rapidly identify and optimize antibody candidates against a wide range of disease targets. By combining experimental data with machine learning, AbCellera accelerates early-stage drug discovery and improves the efficiency of lead candidate selection.
AbCellera primarily operates through partnerships with pharmaceutical and biotechnology firms, offering its antibody discovery services on a fee-for-service and milestone-driven basis.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
The article "AbCellera Biologics Q1 Earnings Call Highlights" was originally published by MarketBeat.
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- Argenx Eyes Larger Patient Pool Following Expanded FDA Nod For Lead Drug For Neuromuscular Disease
May 11, 2026 · benzinga.com
Argenx SE – ADR (NASDAQ:ARGX) shares are up during Monday's session as the company celebrates a recent FDA approval for its drug, VYVGART, which adult patients with generalized myasthenia gravis can use.
- Argenx Wins FDA Nod Expanding VYVGART Label To All Adult GMG Patients
May 11, 2026
(RTTNews) - argenx SE (ARGX) announced that the U.S. FDA has approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG).
VYVGART Hytrulo was initially approved by the FDA on June 20, 2023, for subcutaneous use in gMG, following the original intravenous formulation approval in December 2021.
The approval extends use of VYVGART and VYVGART Hytrulo to all adult gMG serotypes including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative patients. Data from the Phase 3 ADAPT SERON study, the largest to date in antibody-negative gMG, showed patients treated with VYVGART experienced rapid, significant and sustained improvements in symptoms such as speech, vision, swallowing, and physical function compared to placebo.
The study met its primary endpoint, demonstrating a statistically significant improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score at week 4 (p=0.0068). Patients achieved a mean 3.35-point improvement from baseline, with benefits observed across subsequent treatment cycles and all serotypes studied. Safety was consistent with the established profile in AChR-Ab positive gMG.
Argenx reported $1.3 billion in global net sales of the VYVGART franchise in Q1 2026, compared with $0.8 billion in Q1 2025 representing 63% year-over-year growth. Full-year 2025 VYVGART generated $4.2 billion, representing 90% growth over $2.2 billion in 2024. The strong uptake of VYVGART IV and VYVGART Hytrulo underscores their commercial momentum alongside regulatory expansion.
With this approval, VYVGART and VYVGART Hytrulo become the first and only therapies available for all gMG patients regardless of antibody status, delivering the broadest MG label to date.
Generalized myasthenia gravis is a rare autoimmune disease that causes debilitating muscle weakness, affecting vision, movement, speech, swallowing, and even breathing. Approximately 20% of patients lack detectable AChR antibodies, making diagnosis and treatment more challenging.
ARGX has traded between $510.05 and $934.62 over the past year. The stock closed Friday's trading (May 8, 2026) at $782.17, down 0.65%. In pre-market trading, the stock is at $802.18, up 2.56%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
- Argenx wins FDA nod to broaden Vyvgart label in myasthenia gravis
May 9, 2026
[Headquarters of US Food and Drug Administration (FDA)]
Grandbrothers/iStock Editorial via Getty Images
The U.S. FDA has approved a label expansion for Vyvgart and Vyvgart Hytrulo in myasthenia gravis, letting a broader section of adults suffering from the autoimmune disease receive the therapy, its manufacturer, argenx (ARGX [https://seekingalpha.com/symbol/ARGX]), said.
In a statement on Friday, the Dutch biotech said that the FDA approved its supplemental Biologics License Application, which sought to expand the Vyvgart label to all serotypes of adults living with generalized myasthenia gravis. [https://seekingalpha.com/pr/20508240-argenx-announces-u-s-fda-approval-expanding-vyvgart-and-vyvgart-hytrulo-for-use-in-all-adult]
The blockbuster therapy, which generated more than $4B in sales globally for argenx (ARGX [https://seekingalpha.com/symbol/ARGX]) last year, was previously available in the U.S. for adults with gMG who are anti-acetylcholine receptor antibody positive.
The neonatal Fc receptor blocker is also indicated for a rare autoimmune condition called chronic inflammatory demyelinating polyneuropathy.
The sBLA, backed by the company’s Phase 3 ADAPT SERON study, was under the FDA’s priority review with a target action date of May 10. [https://seekingalpha.com/news/4538700-argenx-vyvgart-label-expansion-gets-fda-priority-review]
argenx (ARGX [https://seekingalpha.com/symbol/ARGX]) has developed Vyvgart Hytrulo, the injectable version of Vyvgart, in partnership with Halozyme (HALO [https://seekingalpha.com/symbol/HALO]).
MORE ON ARGENX SE, HALOZYME THERAPEUTICS
* argenx SE (ARGX) Q1 2026 Earnings Call Transcript [https://seekingalpha.com/article/4900771-argenx-se-argx-q1-2026-earnings-call-transcript]
* Halozyme Therapeutics: The Royalty Engine Is Becoming A Drug-Delivery Toll Road [https://seekingalpha.com/article/4899012-halozyme-therapeutics-stock-royalty-engine-is-becoming-a-drug-delivery-toll-road]
* Halozyme Therapeutics, Inc. (HALO) Presents at The Citizens Life Sciences Conference 2026 Transcript [https://seekingalpha.com/article/4881160-halozyme-therapeutics-inc-halo-presents-at-the-citizens-life-sciences-conference-2026]
* Halozyme Therapeutics Q1 2026 Earnings Preview [https://seekingalpha.com/news/4589985-halozyme-therapeutics-q1-2026-earnings-preview]
* Argenx targets 2.5x more VYVGART patients by decade-end as Phase III empasiprubart MMN readout nears 4Q [https://seekingalpha.com/news/4589193-argenx-targets-2_5x-more-vyvgart-patients-by-decade-end-as-phase-iii-empasiprubart-mmn]
- argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 8, 2026
VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegativePatients treated with VYVGART in the ADAPT SERON study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment Approval advances argenx’s commitment to address the unique needs of every MG patient, delivering the broadest MG label to date
May 8, 2026, 5:20 PM 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 the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
The approval is based on data from the Phase 3 ADAPT SERON study, the largest study to date of patients with gMG who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The overall population of patients in the study treated with VYVGART showed rapid, significant and sustained improvements in their gMG symptoms, including speech, vision, physical function and swallowing, among others. In addition, VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.
“Today’s approval means that all adult gMG patients, regardless of serotype, can now benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "For clinicians, this simplifies treatment decisions, representing a major advancement in reaching as many patients living with gMG as possible.”
“MG affects patients in various ways, and those with gMG who do not have detectable AChR antibodies need safe, effective treatments. Prior to the ADAPT SERON study, these patients were rarely included in clinical trials,” said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine. “MG leads to debilitating muscle weakness, causing challenges with vision, movement, speech, swallowing, and even breathing. Although many MG patients have detectable AChR-Ab, roughly 20% do not, making diagnosis and management especially difficult. The expanded indication of efgartigimod for use in all adult gMG patients enables healthcare providers to prescribe this targeted treatment more readily upon clinical diagnosis, irrespective of serotype.”
Detailed results from the Phase 3 ADAPT SERON study:
Patients showed clinically meaningful improvements in disease activity across all three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.The primary endpoint was met (p=0.0068), demonstrating that patients treated with VYVGART achieved a statistically significant improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo at week 4.In the overall population – across all serotypes in the study – 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 serotypes studied.VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.
“For too long, gMG patients who do not have detectable AChR-Ab have been left behind, feeling disengaged and excluded from receiving treatments that specifically treat their disease, which has led to patients experiencing a higher burden of suffering,” said Allison Foss, Executive Director of the Myasthenia Gravis Association. “This approval validates that gMG patients without AChR-Ab can benefit from a targeted treatment, bringing a sense of hope to thousands in our community.”
argenx recently announced positive top-line results from the ADAPT OCULUS study of VYVGART Hytrulo in ocular MG and remains focused on advancing the development of VYVGART for all patients living with MG, including pediatric gMG patient populations in the ADAPT Jr study.
VYVGART is available to patients in three administration options, including VYVGART Hytrulo self-injection with a prefilled syringe.
Access Support for VYVGART® and VYVGART Hytrulo®
The argenx patient support program, My VYVGART® Path, can help patients and healthcare providers navigate access. My VYVGART® Path resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. argenx is committed to supporting access for patients to its medicines.
More information is available at VYVGART.com.
About 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 positive gMG. Approximately 20% of patients with gMG do not have detectable serum antibodies directed against AChR and are referred to as having anti-AChR antibody negative 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.
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 anti-AChR antibody negative 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. Part B is an open-label period: 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 week 4 (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 anti-AChR antibody negative gMG, which included participants who are anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
MG-ADL is a validated measure of disease activity in patients living with MG, which evaluates the functional impact of symptoms on daily activities such as speaking, chewing, swallowing, breathing, and limb strength.
See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART for additional information.
Important Safety Information
What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG).
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
• have an infection or fever.
• have recently received or are scheduled to receive any vaccinations.
• have any history of allergic reactions.
• have kidney (renal) problems.
• are pregnant or plan to become pregnant. It is not known whether VYVGART or VYVGART HYTRULO will harm your unborn baby.
o Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
• are breastfeeding or plan to breastfeed. It is not known if VYVGART or VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART or VYVGART HYTRULO can cause side effects which can be serious, including:
• Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever, chills, frequent and painful urination, cough, pain and blockage of nasal passages, wheezing, shortness of breath, sore throat, excess phlegm, and nasal discharge.
• Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction with VYVGART or VYVGART HYTRULO: rash, swelling of the face, lips, throat, or throat, shortness of breath, trouble breathing, low blood pressure, and fainting.
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
• Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: high blood pressure, chills, shivering, and chest, stomach, or back pain.
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information for VYVGART and full Prescribing Information for VYVGART HYTRULO.
About VYVGART and VYVGART Hytrulo
VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.
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 “advance,” “aim,” “bring,” “can,” “commit,” “continue,” and “expand,” and include statements argenx makes concerning the Approval’s advancing of argenx’s commitment to address the unique needs of every MG patient, delivering the broadest MG label to date; its belief that all adult gMG patients, regardless of serotype, can now benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile; its belief that the Approval represents a major advancement in reaching as many patients living with gMG as possible; its commitment to advancing the development of VYVGART for all patients living with MG, including pediatric gMG patient populations in the ADAPT Jr study; its commitment to improve the lives of people suffering from severe autoimmune diseases; its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its commercialization of the first approved neonatal Fc receptor (FcRn) blocker; the FcRn blocker’s broad potential in multiple serious autoimmune diseases; and its advancement of several earlier-stage experimental medicines within its therapeutic franchises. 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.
- argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 8, 2026
argenx SE
VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative Patients treated with VYVGART in the ADAPT SERON study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment Approval advances argenx’s commitment to address the unique needs of every MG patient, delivering the broadest MG label to date
May 8, 2026, 5:20 PM 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 the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
The approval is based on data from the Phase 3 ADAPT SERON study, the largest study to date of patients with gMG who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The overall population of patients in the study treated with VYVGART showed rapid, significant and sustained improvements in their gMG symptoms, including speech, vision, physical function and swallowing, among others. In addition, VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.
“Today’s approval means that all adult gMG patients, regardless of serotype, can now benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "For clinicians, this simplifies treatment decisions, representing a major advancement in reaching as many patients living with gMG as possible.”
“MG affects patients in various ways, and those with gMG who do not have detectable AChR antibodies need safe, effective treatments. Prior to the ADAPT SERON study, these patients were rarely included in clinical trials,” said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine. “MG leads to debilitating muscle weakness, causing challenges with vision, movement, speech, swallowing, and even breathing. Although many MG patients have detectable AChR-Ab, roughly 20% do not, making diagnosis and management especially difficult. The expanded indication of efgartigimod for use in all adult gMG patients enables healthcare providers to prescribe this targeted treatment more readily upon clinical diagnosis, irrespective of serotype.”
Story Continues
Detailed results from the Phase 3 ADAPT SERON study:
Patients showed clinically meaningful improvements in disease activity across all three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The primary endpoint was met (p=0.0068), demonstrating that patients treated with VYVGART achieved a statistically significant improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo at week 4. In the overall population – across all serotypes in the study – 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 serotypes studied. VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.
“For too long, gMG patients who do not have detectable AChR-Ab have been left behind, feeling disengaged and excluded from receiving treatments that specifically treat their disease, which has led to patients experiencing a higher burden of suffering,” said Allison Foss, Executive Director of the Myasthenia Gravis Association. “This approval validates that gMG patients without AChR-Ab can benefit from a targeted treatment, bringing a sense of hope to thousands in our community.”
argenx recently announced positive top-line results from the ADAPT OCULUS study of VYVGART Hytrulo in ocular MG and remains focused on advancing the development of VYVGART for all patients living with MG, including pediatric gMG patient populations in the ADAPT Jr study.
VYVGART is available to patients in three administration options, including VYVGART Hytrulo self-injection with a prefilled syringe.
Access Support for VYVGART® and VYVGART Hytrulo®
The argenx patient support program, My VYVGART® Path, can help patients and healthcare providers navigate access. My VYVGART® Path resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. argenx is committed to supporting access for patients to its medicines.
More information is available at VYVGART.com.
About 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 positive gMG. Approximately 20% of patients with gMG do not have detectable serum antibodies directed against AChR and are referred to as having anti-AChR antibody negative 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.
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 anti-AChR antibody negative 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. Part B is an open-label period: 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 week 4 (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 anti-AChR antibody negative gMG, which included participants who are anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
MG-ADL is a validated measure of disease activity in patients living with MG, which evaluates the functional impact of symptoms on daily activities such as speaking, chewing, swallowing, breathing, and limb strength.
See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART for additional information.
Important Safety Information
What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG).
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
• have an infection or fever.
• have recently received or are scheduled to receive any vaccinations.
• have any history of allergic reactions.
• have kidney (renal) problems.
• are pregnant or plan to become pregnant. It is not known whether VYVGART or VYVGART HYTRULO will harm your unborn baby.
o Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
• are breastfeeding or plan to breastfeed. It is not known if VYVGART or VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART or VYVGART HYTRULO can cause side effects which can be serious, including:
• Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever, chills, frequent and painful urination, cough, pain and blockage of nasal passages, wheezing, shortness of breath, sore throat, excess phlegm, and nasal discharge.
• Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction with VYVGART or VYVGART HYTRULO: rash, swelling of the face, lips, throat, or throat, shortness of breath, trouble breathing, low blood pressure, and fainting.
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
• Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: high blood pressure, chills, shivering, and chest, stomach, or back pain.
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information for VYVGART and full Prescribing Information for VYVGART HYTRULO.
About VYVGART and VYVGART Hytrulo
VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.
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 “advance,” “aim,” “bring,” “can,” “commit,” “continue,” and “expand,” and include statements argenx makes concerning the Approval’s advancing of argenx’s commitment to address the unique needs of every MG patient, delivering the broadest MG label to date; its belief that all adult gMG patients, regardless of serotype, can now benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile; its belief that the Approval represents a major advancement in reaching as many patients living with gMG as possible; its commitment to advancing the development of VYVGART for all patients living with MG, including pediatric gMG patient populations in the ADAPT Jr study; its commitment to improve the lives of people suffering from severe autoimmune diseases; its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its commercialization of the first approved neonatal Fc receptor (FcRn) blocker; the FcRn blocker’s broad potential in multiple serious autoimmune diseases; and its advancement of several earlier-stage experimental medicines within its therapeutic franchises. 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.
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- argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 8, 2026 · globenewswire.com
VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative Patients treated with VYVGART in the ADAPT SERON study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment Approval advances argenx's commitment to address the unique needs of every MG patient, delivering the broadest MG label to date May 8, 2026, 5:20 PM 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 the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). The approved supplemental Biologics License Application (sBLA) expands VYVGART's indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
- ARGENX ANNOUNCES U.S. FDA APPROVAL EXPANDING VYVGART AND VYVGART HYTRULO FOR USE IN ALL ADULT PATIENTS LIVING WITH GMG
May 8, 2026
VYVGART AND VYVGART HYTRULO ARE THE FIRST AND ONLY APPROVED TREATMENTS FOR ALL SEROTYPES OF ADULT PATIENTS LIVING WITH GMG – ANTI-ACHR-AB POSITIVE, ANTI-MUSK-AB POSITIVE, ANTI-LRP4-AB POSITIVE, AND TRIPLE SERONEGATIVE PATIENTS TREATED WITH VYVGART IN THE ADAPT SERON STUDY EXPERIENCED RAPID, SIGNIFICANT AND SUSTAINED SYMPTOM IMPROVEMENTS THAT CONTINUED WITH ONGOING TREATMENT APPROVAL ADVANCES ARGENX'S COMMITMENT TO ADDRESS THE UNIQUE NEEDS OF EVERY MG PATIENT, DELIVERING THE BROADEST MG LABEL TO DATE MAY 8, 2026, 5:20 PM 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 THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVED A LABEL EXPANSION FOR VYVGART® (EFGARTIGIMOD ALFA-FCAB) AND VYVGART HYTRULO® (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) FOR THE TREATMENT OF ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (GMG). THE APPROVED SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) EXPANDS VYVGART'S INDICATION TO INCLUDE ALL SEROTYPES OF ADULT PATIENTS LIVING WITH GMG – ANTI-ACHR-AB POSITIVE, ANTI-MUSK-AB POSITIVE, ANTI-LRP4-AB POSITIVE, AND TRIPLE SERONEGATIVE.
