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argenx Wins FDA Priority Review for VYVGART in Seronegative gMG

Story Highlights
  • FDA accepted argenx’s priority review sBLA for VYVGART in seronegative gMG.
  • Positive Phase 3 ADAPT SERON results support label expansion, potentially broadening VYVGART’s market reach.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
argenx Wins FDA Priority Review for VYVGART in Seronegative gMG

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Argenx Se ( (ARGX) ) just unveiled an update.

On January 13, 2026, argenx SE announced that the U.S. Food and Drug Administration accepted for priority review its supplemental Biologics License Application for intravenous VYVGART (efgartigimod alfa-fcab) to treat adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, a patient group with high unmet need and no approved options for certain subtypes. The filing, backed by positive Phase 3 ADAPT SERON data showing statistically significant and clinically meaningful improvements in disease activity and a safety profile consistent with prior use, sets a Prescription Drug User Fee Act target action date of May 10, 2026, positioning argenx to potentially broaden VYVGART’s label, strengthen its foothold in the gMG market, and expand its addressable patient population if approval is granted.

The most recent analyst rating on (ARGX) stock is a Hold with a $900.00 price target. To see the full list of analyst forecasts on Argenx Se stock, see the ARGX Stock Forecast page.

Spark’s Take on ARGX Stock

According to Spark, TipRanks’ AI Analyst, ARGX is a Outperform.

Argenx Se’s strong financial performance and bullish technical indicators are the primary drivers of its high stock score. The company’s robust revenue growth and strategic advancements in its pipeline are significant positives. However, the high valuation and operational challenges in cash flow generation slightly temper the overall score.

To see Spark’s full report on ARGX stock, click here.

More about Argenx Se

argenx SE is a global immunology company focused on developing and commercializing antibody-based medicines for severe autoimmune diseases. Through its Immunology Innovation Program, argenx partners with academic researchers to build a portfolio of novel therapies, including VYVGART, the first approved neonatal Fc receptor (FcRn) blocker for generalized myasthenia gravis (gMG) in multiple major markets, with ongoing development across additional autoimmune indications.

Average Trading Volume: 355,564

Technical Sentiment Signal: Buy

Current Market Cap: $50.04B

For detailed information about ARGX stock, go to TipRanks’ Stock Analysis page.

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