---
title: "FDA Accepts Priority Review for arGEN-X SE's VYVGART in Seronegative gMG"
type: "News"
locale: "zh-CN"
url: "https://longbridge.com/zh-CN/news/272365599.md"
datetime: "2026-01-13T06:00:11.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/272365599.md)
  - [en](https://longbridge.com/en/news/272365599.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/272365599.md)
---

> 支持的语言: [English](https://longbridge.com/en/news/272365599.md) | [繁體中文](https://longbridge.com/zh-HK/news/272365599.md)


# FDA Accepts Priority Review for arGEN-X SE's VYVGART in Seronegative gMG

argenx SE announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART (efgartigimod alfa-fcab) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. The application is supported by data from the Phase 3 ADAPT SERON study, which demonstrated statistically significant improvements in MG-ADL total score in patients treated with VYVGART compared to placebo. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. arGEN-X SE published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001158967-en) on January 13, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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