Argenx's VYVGART Receives FDA Priority Review for First Treatment of AChR-Ab Seronegative MG
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 13 2026
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Source: NASDAQ.COM
- FDA Priority Review: Argenx SE's VYVGART has received a Priority Review from the U.S. FDA for treating AChR-Ab seronegative myasthenia gravis, with a decision expected by May 10, 2026, potentially addressing a significant treatment gap for this patient population.
- Clinical Data Support: The supplemental application is backed by Phase 3 ADAPT SERON study data, demonstrating statistically significant improvements in MG-ADL scores across all seronegative subgroups, indicating VYVGART's clinically meaningful efficacy and reinforcing its market position.
- Global Market Performance: VYVGART is already approved in major global markets for AChR-positive myasthenia gravis, with projected global product net sales of $4.15 billion in 2025, reflecting a 90% year-over-year increase, showcasing strong market demand and growth potential.
- Diverse Product Line: Argenx has also launched VYVGART SC, utilizing Halozyme's ENHANZE drug delivery technology, further expanding the product's applicability and market reach, enhancing the company's competitive edge in the biopharmaceutical sector.
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Analyst Views on ARGX
Wall Street analysts forecast ARGX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ARGX is 1041 USD with a low forecast of 858.00 USD and a high forecast of 1264 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 847.720
Low
858.00
Averages
1041
High
1264
Current: 847.720
Low
858.00
Averages
1041
High
1264
About ARGX
argenx SE, formerly arGEN X BV, is a Netherlands-based biopharmaceutical company. It is primarily engaged in creating and developing a pipeline of differentiated antibody therapeutics for the treatment of severe autoimmune diseases using its discovery platform, Simple Antibody, which exploits characteristics of the llama immune system. The Company develops a pipeline of antibody therapeutics focused on cancer and autoimmune indications. It includes, but is not limited to: Empasiprubart, a complement inhibitor targeting C2, blocking the function of both the classical and lectin pathways, while leaving the alternative pathway intact, ARGX-119 an antagonist to the MuSK receptor with potential in multiple neuromuscular indications.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Argenx (ARGX) Receives FDA Priority Review for Vyvgart Expansion Application
- FDA Priority Review: Argenx announced that its supplemental Biologics License Application for Vyvgart, targeting AChR-Ab negative generalized myasthenia gravis, has received priority review from the FDA, marking a significant advancement in expanding treatment indications.
- Target Action Date: The FDA has set May 10, 2026, as the target action date for this application, and approval would further solidify Vyvgart's market position in the rare autoimmune disease treatment sector.
- Clinical Data Support: The application is supported by data from Argenx's Phase 3 ADAPT SERON study, which met the primary endpoint related to a gMG clinical measure over four weeks, demonstrating Vyvgart's potential in the new indication.
- Market Performance: Vyvgart generated $2.2 billion in global product net sales for Argenx in 2024, and approval for the new indication could significantly enhance future sales growth and market share.
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