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argenx (NASDAQ:ARGX) announced positive topline results from its ADAPT SERON phase 3 study of VYVGART® in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients. The study achieved its primary endpoint with statistical significance (p=0.0068), demonstrating meaningful improvements in patients’ daily living activities compared to placebo.
This marks the first global phase 3 study showing clinical benefits across all three seronegative subtypes: MuSK+, LRP4+, and triple seronegative. The company plans to submit a Supplemental Biologics License Application (sBLA) to the FDA by the end of 2025 to expand VYVGART’s label. The drug maintained its established safety profile with no new concerns identified.
argenx (NASDAQ:ARGX) ha comunicato risultati topline positivi dallo studio di fase 3 ADAPT SERON su VYVGART® nei pazienti con miastenia gravis generalizzata (gMG) sieronegativa per AChR. Lo studio ha raggiunto il suo end point primario con significatività statistica (p=0,0068), mostrando miglioramenti rilevanti nelle attività quotidiane rispetto al placebo.
Si tratta del primo studio globale di fase 3 che dimostra benefici clinici in tutte e tre le sottoclassi sieronegative: MuSK+, LRP4+ e tripla sieronegativa. L’azienda intende presentare una Supplemental Biologics License Application (sBLA) alla FDA entro la fine del 2025 per ampliare l’indicazione di VYVGART. Il farmaco ha mantenuto il profilo di sicurezza noto, senza nuove preoccupazioni identificate.
argenx (NASDAQ:ARGX) anunció resultados topline positivos del estudio de fase 3 ADAPT SERON de VYVGART® en pacientes con miastenia gravis generalizada (gMG) seronegativa para AChR. El estudio alcanzó su objetivo primario con significación estadística (p=0,0068), mostrando mejoras relevantes en las actividades diarias frente a placebo.
Es el primer estudio global de fase 3 que evidencia beneficios clínicos en las tres subtipos seronegativas: MuSK+, LRP4+ y triple seronegativa. La compañía planea presentar una Supplemental Biologics License Application (sBLA) a la FDA antes de finales de 2025 para ampliar la indicación de VYVGART. El fármaco mantuvo su perfil de seguridad conocido, sin nuevos problemas identificados.
argenx (NASDAQ:ARGX)는 AChR 항체 음성 전신성 중증근무력증(gMG) 환자를 대상으로 한 VYVGART®의 ADAPT SERON 3상 시험에서 긍정적인 톱라인 결과를 발표했습니다. 연구는 주요 평가변수에서 통계적 유의성(p=0.0068)을 확보하며 위약 대비 일상생활 기능에서 의미 있는 개선을 보였습니다.
이번 결과는 MuSK+, LRP4+, 삼중 음성을 포함한 세 가지 음성 아형 전체에서 임상적 이익을 보인 세계 최초의 3상 연구입니다. 회사는 VYVGART의 적응증을 확대하기 위해 2025년 말까지 FDA에 Supplemental Biologics License Application (sBLA)을 제출할 계획입니다. 약물은 기존의 안전성 프로파일을 유지했으며 새로운 우려는 확인되지 않았습니다.
argenx (NASDAQ:ARGX) a annoncé des résultats topline positifs de l’étude de phase 3 ADAPT SERON de VYVGART® chez des patients atteints de myasthénie grave généralisée (gMG) séronégative pour les anticorps AChR. L’étude a atteint son critère principal avec une signification statistique (p=0,0068), montrant des améliorations significatives des activités quotidiennes par rapport au placebo.
Il s’agit du premier essai mondial de phase 3 à démontrer des bénéfices cliniques pour les trois sous‑types séronégatifs : MuSK+, LRP4+ et triple séronégatif. La société prévoit de soumettre une Supplemental Biologics License Application (sBLA) à la FDA d’ici la fin 2025 afin d’élargir le libellé de VYVGART. Le médicament a conservé son profil de sécurité établi, sans nouvelles préoccupations identifiées.
argenx (NASDAQ:ARGX) gab positive Topline-Ergebnisse der Phase‑3‑Studie ADAPT SERON mit VYVGART® bei AChR‑Antikörper‑seronegativen Patienten mit generalisierter Myasthenia gravis (gMG) bekannt. Die Studie erreichte ihren primären Endpunkt mit statistischer Signifikanz (p=0,0068) und zeigte gegenüber Placebo bedeutsame Verbesserungen bei Alltagsaktivitäten.
Dies ist die erste globale Phase‑3‑Studie, die klinische Vorteile in allen drei seronegativen Subtypen nachweist: MuSK+, LRP4+ und dreifach seronegativ. Das Unternehmen plant, bis Ende 2025 eine Supplemental Biologics License Application (sBLA) bei der FDA einzureichen, um das Label von VYVGART zu erweitern. Das Medikament zeigte kein neues Sicherheitsproblem und behielt sein bekanntes Sicherheitsprofil bei.
Positive
- Study met primary endpoint with statistical significance (p=0.0068)
- First global phase 3 study showing benefits across all three seronegative subtypes
- Well-tolerated safety profile consistent with previous studies
- Potential label expansion to cover all gMG patient subtypes
Insights
argenx’s VYVGART shows efficacy in seronegative gMG patients, significantly expanding its market potential across all myasthenia gravis subtypes.
This is a significant breakthrough in the treatment landscape for myasthenia gravis (MG). The ADAPT SERON study demonstrates that VYVGART (efgartigimod alfa-fcab) effectively treats AChR-Ab seronegative gMG patients – a population with historically limited treatment options.
The statistical significance (p-value=0.0068) in the primary endpoint measuring improvements in MG-ADL scores indicates robust efficacy. Most critically, this study represents the first global Phase 3 trial showing meaningful improvements across all three seronegative subtypes – MuSK+, LRP4+, and triple seronegative patients.
From a commercial perspective, this positive data positions argenx to expand VYVGART’s addressable market substantially. The planned sBLA submission to the FDA by year-end 2025 could lead to label expansion, allowing argenx to target the entire gMG patient population regardless of antibody status.
The consistent safety profile across seronegative subtypes – with no new safety concerns identified – strengthens VYVGART’s competitive position. These results validate argenx’s mechanistic approach targeting pathogenic IgGs as underlying drivers of gMG across all patient subtypes, potentially establishing VYVGART as a foundational therapy for the broader MG population.
argenx (ARGX) Surges on Positive Phase 3 Data for VYVGART in Seronegative gMG, Eyes FDA Submission by 2025
August 25, 2025 – In a move poised to shake up the myasthenia gravis (MG) treatment landscape, argenx SE (NASDAQ: ARGX) announced stellar topline results from its ADAPT SERON study, sending shares higher in pre-market trading. The trial, evaluating VYVGART® (efgartigimod alfa-fcab) in patients with AChR-Ab seronegative generalized myasthenia gravis (gMG), achieved its primary endpoint with a highly statistically significant p-value of 0.0068.
This isn’t just another incremental improvement; it’s a potential game-changer. The study demonstrated that patients treated with VYVGART experienced notable and clinically meaningful improvements in their daily living activities, as measured by the MG-ADL (Myasthenia Gravis Activities of Daily Living) total score, compared to those receiving a placebo. Crucially, ADAPT SERON marks the first global Phase 3 study to showcase clinical benefits spanning all three seronegative subtypes: MuSK+, LRP4+, and triple seronegative. These are patient populations often underserved by existing therapies, representing a significant unmet medical need.
argenx isn’t wasting any time capitalizing on this success. The company plans to submit a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) by the close of 2025, seeking to broaden VYVGART’s label to encompass adult AChR-Ab seronegative gMG patients across all three subtypes. A positive decision from the FDA would dramatically expand VYVGART’s addressable market, potentially positioning it as a foundational therapy for a wider range of gMG patients.
“The results of the ADAPT SERON study confirm that VYVGART now has the potential to be a targeted, effective, safe, and necessary treatment for patients living with gMG, regardless of autoantibody status,” remarked Dr. James F. Howard Jr., Principal Investigator for the trial and Professor of Neurology at the University of North Carolina at Chapel Hill School of Medicine.
Adding to the bullish narrative, VYVGART maintained its already established safety profile in the study, with no new safety concerns emerging across the seronegative subtypes. This consistency reinforces investor confidence in the drug’s risk-benefit profile.
This announcement underscores argenx’s strategic focus on immunology and its commitment to developing innovative therapies for severe autoimmune diseases. The company’s Immunology Innovation Program (IIP) continues to be a key driver of its success, translating cutting-edge immunology research into novel antibody-based medicines.
08/25/2025 – 01:00 AM
- Study met primary endpoint (p-value=0.0068)
- First global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative
- Supplemental Biologics License Application (sBLA) to be submitted to U.S. Food and Drug Administration (FDA) by end of 2025
FAQ
What were the results of argenx’s ADAPT SERON study for VYVGART?
The study met its primary endpoint (p=0.0068), showing statistically significant improvements in MG-ADL scores compared to placebo in AChR-Ab seronegative gMG patients.
When will argenx submit the sBLA for VYVGART’s label expansion?
argenx plans to submit the Supplemental Biologics License Application (sBLA) to the FDA by the end of 2025.
Which patient subtypes were included in the ADAPT SERON study?
The study included all three AChR-Ab seronegative gMG subtypes: MuSK+, LRP4+, and triple seronegative patients.
What was the safety profile of VYVGART in the ADAPT SERON trial?
VYVGART was well-tolerated and safe across all subtypes, consistent with its established safety profile in AChR-Ab seropositive gMG patients, with no new safety concerns identified.
How does this study impact the treatment landscape for gMG patients?
This is the first global phase 3 study demonstrating clinical benefits across all seronegative subtypes, potentially providing a new treatment option for patients with limited alternatives.
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