argenx Submits VYVGART sBLA for FDA Priority Review, Target Date May 10, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 13 2026
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Source: Globenewswire
- FDA Priority Review: The U.S. FDA has accepted argenx's supplemental Biologics License Application for VYVGART, with a target action date of May 10, 2026, indicating the drug's potential to address the urgent treatment needs of patients with AChR-Ab seronegative generalized myasthenia gravis.
- Clinical Trial Results: In the Phase 3 ADAPT SERON study, VYVGART demonstrated a statistically significant average improvement of 3.35 points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score after four weeks (p-value=0.0068), potentially enhancing patients' quality of life.
- Good Safety Profile: VYVGART exhibited a favorable safety profile consistent with previous data, with no new safety concerns identified, thereby supporting its broader application among diverse patient populations.
- Global Study Design: The ADAPT SERON study was conducted across North America, Europe, China, and the Middle East with 119 patients, utilizing a randomized, double-blind, placebo-controlled design that ensures the reliability and applicability of the results, further enhancing VYVGART's market prospects.
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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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