We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
ARGX Shares Gain Nearly 9% in a Month: Here's What You Need to Know
Read MoreHide Full Article
Key Takeaways
ARGX won FDA approval to expand Vyvgart use to adult gMG patients regardless of antibody status.
Vyvgart label expansion was backed by phase III ADAPT SERON data showing symptom improvement.
argenx reported $1.3 billion in first-quarter 2026 Vyvgart sales, up 63% year over year.
Shares of argenx SE (ARGX - Free Report) have risen nearly 9% over the past month. The upside came after the company announced in mid-May that the FDA had approved expanded use of its blockbuster therapy, Vyvgart and Vyvgart Hytrulo, for use in adult patients with generalized myasthenia gravis (gMG), regardless of antibody status. The approval was granted ahead of the agency’s May 10, 2026, target action date.
Previously, Vyvgart was approved only for gMG patients who tested positive for acetylcholine receptor (AChR) antibodies. With this new approval, the treatment can also be used in patients who are positive for MuSK antibodies, LRP4 antibodies or who do not test positive for any of these antibodies (triple seronegative).
Year to date, shares of ARGX have risen 5.1% against the industry’s 3.2% decline.
Image Source: Zacks Investment Research
ARGX Expands Vyvgart Label Following Phase III ADAPT SERON
The FDA approval for the label expansion of Vyvgart and Vyvgart Hytrulo was supported by positive data from the phase III ADAPT SERON study, the largest study conducted in gMG patients without detectable AChR antibodies. The study met its primary endpoint by demonstrating a statistically significant improvement in disease symptoms compared with placebo. The treatment with Vyvgart led to rapid and sustained improvements in speech, vision, swallowing and physical function across anti-MuSK-positive, anti-LRP4-positive and triple-seronegative patients. The treatment was well-tolerated, with a safety profile consistent with previously conducted studies in AChR-antibody-positive gMG patients.
gMG is a rare autoimmune neuromuscular disorder in which harmful antibodies disrupt communication between nerves and muscles, leading to muscle weakness, fatigue and potentially life-threatening complications.
Vyvgart: ARGX’s Key Growth Driver
Vyvgart is the first and only FcRn-targeting IgG1 antibody fragment approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP) across multiple global markets. The drug continues to deliver strong commercial performance. Vyvgart generated $1.3 billion in global net product sales in the first quarter of 2026, up 63% year over year.
The therapy is also approved in Japan for primary immune thrombocytopenia (ITP). Vyvgart is available in multiple administration formats, including intravenous infusion, the subcutaneous formulation Vyvgart Hytrulo and a self-injectable prefilled syringe, providing patients with greater treatment flexibility and convenience.
Beyond gMG and CIDP, argenx is pursuing significant label expansion opportunities for Vyvgart. The company announced positive top-line data from the phase III ADAPT OCULUS study in February 2026, in which Vyvgart Hytrulo met its primary endpoint in adults with ocular myasthenia gravis. Development is ongoing in pediatric gMG and several additional autoimmune diseases.
Key pipeline catalysts include top-line data from the ADVANCE-NEXT study in primary ITP in the first half of 2027 and the UNITY study in Sjögren’s disease in the second half of 2027. A registrational study evaluating Vyvgart in Graves’ disease is expected to begin in 2026. The planned launch of the Vyvgart SC Autoinjector in 2027 could enhance patient convenience and support broader adoption across approved indications.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.94. Over the same period, EPS estimates for 2027 have risen to $4.81 from $3.79. LQDA shares have gained 85.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 remained unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
ARGX Shares Gain Nearly 9% in a Month: Here's What You Need to Know
Key Takeaways
Shares of argenx SE (ARGX - Free Report) have risen nearly 9% over the past month. The upside came after the company announced in mid-May that the FDA had approved expanded use of its blockbuster therapy, Vyvgart and Vyvgart Hytrulo, for use in adult patients with generalized myasthenia gravis (gMG), regardless of antibody status. The approval was granted ahead of the agency’s May 10, 2026, target action date.
Previously, Vyvgart was approved only for gMG patients who tested positive for acetylcholine receptor (AChR) antibodies. With this new approval, the treatment can also be used in patients who are positive for MuSK antibodies, LRP4 antibodies or who do not test positive for any of these antibodies (triple seronegative).
Year to date, shares of ARGX have risen 5.1% against the industry’s 3.2% decline.
Image Source: Zacks Investment Research
ARGX Expands Vyvgart Label Following Phase III ADAPT SERON
The FDA approval for the label expansion of Vyvgart and Vyvgart Hytrulo was supported by positive data from the phase III ADAPT SERON study, the largest study conducted in gMG patients without detectable AChR antibodies. The study met its primary endpoint by demonstrating a statistically significant improvement in disease symptoms compared with placebo. The treatment with Vyvgart led to rapid and sustained improvements in speech, vision, swallowing and physical function across anti-MuSK-positive, anti-LRP4-positive and triple-seronegative patients. The treatment was well-tolerated, with a safety profile consistent with previously conducted studies in AChR-antibody-positive gMG patients.
gMG is a rare autoimmune neuromuscular disorder in which harmful antibodies disrupt communication between nerves and muscles, leading to muscle weakness, fatigue and potentially life-threatening complications.
Vyvgart: ARGX’s Key Growth Driver
Vyvgart is the first and only FcRn-targeting IgG1 antibody fragment approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP) across multiple global markets. The drug continues to deliver strong commercial performance. Vyvgart generated $1.3 billion in global net product sales in the first quarter of 2026, up 63% year over year.
The therapy is also approved in Japan for primary immune thrombocytopenia (ITP). Vyvgart is available in multiple administration formats, including intravenous infusion, the subcutaneous formulation Vyvgart Hytrulo and a self-injectable prefilled syringe, providing patients with greater treatment flexibility and convenience.
Beyond gMG and CIDP, argenx is pursuing significant label expansion opportunities for Vyvgart. The company announced positive top-line data from the phase III ADAPT OCULUS study in February 2026, in which Vyvgart Hytrulo met its primary endpoint in adults with ocular myasthenia gravis. Development is ongoing in pediatric gMG and several additional autoimmune diseases.
Key pipeline catalysts include top-line data from the ADVANCE-NEXT study in primary ITP in the first half of 2027 and the UNITY study in Sjögren’s disease in the second half of 2027. A registrational study evaluating Vyvgart in Graves’ disease is expected to begin in 2026. The planned launch of the Vyvgart SC Autoinjector in 2027 could enhance patient convenience and support broader adoption across approved indications.
argenex SE Price and Consensus
argenex SE price-consensus-chart | argenex SE Quote
AGRX's Zacks Rank & Stocks to Consider
argenx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.94. Over the same period, EPS estimates for 2027 have risen to $4.81 from $3.79. LQDA shares have gained 85.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 remained unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.