Argenx's Vyvgart sBLA Accepted for FDA Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 13 2026
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Should l Buy ARGX?
Argenx announced that the FDA has accepted for priority review a supplemental biologics license application, or sBLA, for Vyvgart for the treatment of adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis. The application has been granted a Prescription Drug User Fee Act target action date of May 10.
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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: 820.310
Low
858.00
Averages
1041
High
1264
Current: 820.310
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.
Argenx SE Rated as One of the Best Growth Stocks for the Next Decade
- Buy Rating Maintained: H.C. Wainwright maintained a Buy rating on Argenx SE (NASDAQ:ARGX) as of January 21, setting a price target of $915, which reflects a modest 8.93% upside from current levels, indicating strong market confidence in its long-term growth potential.
- Price Target Increase: On January 20, Wells Fargo reiterated its Buy rating on Argenx SE while raising its price target from $1,264 to $1,317, implying a further 55% upside from current levels, showcasing analysts' optimism about the company's future performance.
- Revenue Estimates Raised: Wells Fargo also increased its Vyvgart revenue estimates for the 2026-2030 period by 5%-15%, reflecting confidence in stronger-than-expected performance, with a consensus revenue estimate of $5.6 billion for FY 2026, suggesting the market may be underestimating the company's growth potential.
- Growth Potential Analysis: According to Wells Fargo's estimates, Argenx SE could achieve $6.5 billion in revenue by 2026, assuming single-digit quarter-over-quarter growth in Q1, followed by low double-digit growth from Q2 to Q4, further solidifying its market position in the biopharmaceutical sector.
See More
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
See More
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.
See More
Argenx's VYVGART Receives FDA Priority Review for First Treatment of AChR-Ab Seronegative MG
- 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.
See More
Argenx (ARGX) Files Supplemental Biologics License Application for Vyvgart
- Application Progress: Argenx announced on Tuesday that its supplemental biologics license application for Vyvgart has been submitted, marking a significant step in expanding its product line, although no specific review timeline has been disclosed.
- Market Potential: If approved, Vyvgart is expected to address unmet medical needs, potentially driving Argenx's market share and revenue growth significantly.
- Strategic Implications: The outcome of this application will directly impact Argenx's future strategic direction, particularly regarding its competitiveness and innovation in the biologics sector.
- Investor Attention: Market reactions to this application will influence Argenx's stock performance, prompting investors to closely monitor subsequent regulatory developments and market feedback.
See More
argenx Submits VYVGART sBLA for FDA Priority Review, Target Date May 10, 2026
- 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.
See More
Argenx SE Rated as One of the Best Growth Stocks for the Next Decade
- Buy Rating Maintained: H.C. Wainwright maintained a Buy rating on Argenx SE (NASDAQ:ARGX) as of January 21, setting a price target of $915, which reflects a modest 8.93% upside from current levels, indicating strong market confidence in its long-term growth potential.
- Price Target Increase: On January 20, Wells Fargo reiterated its Buy rating on Argenx SE while raising its price target from $1,264 to $1,317, implying a further 55% upside from current levels, showcasing analysts' optimism about the company's future performance.
- Revenue Estimates Raised: Wells Fargo also increased its Vyvgart revenue estimates for the 2026-2030 period by 5%-15%, reflecting confidence in stronger-than-expected performance, with a consensus revenue estimate of $5.6 billion for FY 2026, suggesting the market may be underestimating the company's growth potential.
- Growth Potential Analysis: According to Wells Fargo's estimates, Argenx SE could achieve $6.5 billion in revenue by 2026, assuming single-digit quarter-over-quarter growth in Q1, followed by low double-digit growth from Q2 to Q4, further solidifying its market position in the biopharmaceutical sector.
See More
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
See More
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.
See More
Argenx's VYVGART Receives FDA Priority Review for First Treatment of AChR-Ab Seronegative MG
- 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.
See More
Argenx (ARGX) Files Supplemental Biologics License Application for Vyvgart
- Application Progress: Argenx announced on Tuesday that its supplemental biologics license application for Vyvgart has been submitted, marking a significant step in expanding its product line, although no specific review timeline has been disclosed.
- Market Potential: If approved, Vyvgart is expected to address unmet medical needs, potentially driving Argenx's market share and revenue growth significantly.
- Strategic Implications: The outcome of this application will directly impact Argenx's future strategic direction, particularly regarding its competitiveness and innovation in the biologics sector.
- Investor Attention: Market reactions to this application will influence Argenx's stock performance, prompting investors to closely monitor subsequent regulatory developments and market feedback.
See More
argenx Submits VYVGART sBLA for FDA Priority Review, Target Date May 10, 2026
- 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.
See More
