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ARGX Announces Positive Phase III Data on Vyvgart Hytrulo, Stock Up
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Key Takeaways
argenx's ALKIVIA study showed a significant 15.4-point greater TIS improvement versus placebo.
Vyvgart Hytrulo's benefits emerged by week 4 and continued through 52 weeks during steroid tapering.
The treatment effect was consistent in IMNM and dermatomyositis, with gains across all six TIS measures.
argenx SE (ARGX - Free Report) announced positive top-line data from the phase III ALKIVIA study evaluating Vyvgart Hytrulo, the subcutaneous formulation of its blockbuster therapy, Vyvgart (efgartigimod alfa and hyaluronidase-qvfc) to support a label expansion in adults with autoimmune myositis. Shares rose 16% on Monday following the announcement.
Autoimmune myositis is a heterogeneous group of autoimmune disorders marked by chronic inflammation and progressive muscle weakness, with some subtypes also causing skin and other systemic manifestations. In the United States, around 100,000 people are affected, including approximately 20,000 with immune-mediated necrotizing myopathy ("IMNM") and 40,000 with dermatomyositis ("DM").
Vyvgart (efgartigimod alfa) is a first-in-class FcRn antagonist that reduces the levels of circulating IgG autoantibodies. 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.Vyvgart Hytrulo combines efgartigimod alfa with recombinant human hyaluronidase PH20 to enable subcutaneous delivery.
Both Vyvgart and Vyvgart Hytrulo are approved for generalized myasthenia gravis (gMG) regardless of antibody status. The company markets Vyvgart Hytrulo for the chronic inflammatory demyelinating polyneuropathy indication. Vyvgart is also approved in Japan for primary immune thrombocytopenia ("ITP").
Year to date, shares of ARGX have risen 17.4% compared with the industry’s 5.1% growth.
Image Source: Zacks Investment Research
Details of ARGX’s ALKIVIA Study Data in Autoimmune Myositis
The phase III ALKIVIA study was conducted globally. It met its primary endpoint by demonstrating that treatment with Vyvgart Hytrulo led to a statistically significant and clinically meaningful 15.4-point greater improvement in mean total improvement score ("TIS") at week 52 compared with placebo.
Treatment benefits emerged as early as week four and were sustained throughout the 52-week study, including during corticosteroid tapering. The treatment effect was consistent across both IMNM and DM.
In the IMNM subgroup, efgartigimod achieved a statistically significant 14.8-point improvement over placebo. In DM, a comparable 14.5-point improvement over placebo was observed, although statistical significance was not achieved. Improvements were also seen across all six core measures contributing to the TIS, including muscle strength, physical function and disease activity.
The positive data marked the first phase III study to demonstrate statistically significant and clinically meaningful improvement in disease activity in IMNM, a severe form of autoimmune myositis with no approved treatment. The drug was generally well-tolerated, with a safety profile consistent with its established profile.
argenx has an exclusive license agreement with Zai Lab for the development and commercialization of Vyvgart and Vyvgart Hytrulo in Greater China.
Other Pipeline Development of ARGX’s Vyvgart
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 ongoing, expanding development into thyroid-driven autoimmunity. 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 Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX's shares have risen 46.2% year to date.
Amneal Pharmaceuticals' earnings beat in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for Precigen’s 2026 have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN's shares have increased 56.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU's shares have declined 19.4% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
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ARGX Announces Positive Phase III Data on Vyvgart Hytrulo, Stock Up
Key Takeaways
argenx SE (ARGX - Free Report) announced positive top-line data from the phase III ALKIVIA study evaluating Vyvgart Hytrulo, the subcutaneous formulation of its blockbuster therapy, Vyvgart (efgartigimod alfa and hyaluronidase-qvfc) to support a label expansion in adults with autoimmune myositis. Shares rose 16% on Monday following the announcement.
Autoimmune myositis is a heterogeneous group of autoimmune disorders marked by chronic inflammation and progressive muscle weakness, with some subtypes also causing skin and other systemic manifestations. In the United States, around 100,000 people are affected, including approximately 20,000 with immune-mediated necrotizing myopathy ("IMNM") and 40,000 with dermatomyositis ("DM").
Vyvgart (efgartigimod alfa) is a first-in-class FcRn antagonist that reduces the levels of circulating IgG autoantibodies. 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.Vyvgart Hytrulo combines efgartigimod alfa with recombinant human hyaluronidase PH20 to enable subcutaneous delivery.
Both Vyvgart and Vyvgart Hytrulo are approved for generalized myasthenia gravis (gMG) regardless of antibody status. The company markets Vyvgart Hytrulo for the chronic inflammatory demyelinating polyneuropathy indication. Vyvgart is also approved in Japan for primary immune thrombocytopenia ("ITP").
Year to date, shares of ARGX have risen 17.4% compared with the industry’s 5.1% growth.
Image Source: Zacks Investment Research
Details of ARGX’s ALKIVIA Study Data in Autoimmune Myositis
The phase III ALKIVIA study was conducted globally. It met its primary endpoint by demonstrating that treatment with Vyvgart Hytrulo led to a statistically significant and clinically meaningful 15.4-point greater improvement in mean total improvement score ("TIS") at week 52 compared with placebo.
Treatment benefits emerged as early as week four and were sustained throughout the 52-week study, including during corticosteroid tapering. The treatment effect was consistent across both IMNM and DM.
In the IMNM subgroup, efgartigimod achieved a statistically significant 14.8-point improvement over placebo. In DM, a comparable 14.5-point improvement over placebo was observed, although statistical significance was not achieved. Improvements were also seen across all six core measures contributing to the TIS, including muscle strength, physical function and disease activity.
The positive data marked the first phase III study to demonstrate statistically significant and clinically meaningful improvement in disease activity in IMNM, a severe form of autoimmune myositis with no approved treatment. The drug was generally well-tolerated, with a safety profile consistent with its established profile.
argenx has an exclusive license agreement with Zai Lab for the development and commercialization of Vyvgart and Vyvgart Hytrulo in Greater China.
Other Pipeline Development of ARGX’s Vyvgart
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 ongoing, expanding development into thyroid-driven autoimmunity. The planned launch of the Vyvgart SC Autoinjector in 2027 could enhance patient convenience and support broader adoption across approved indications.
AGRX's Zacks Rank & Stocks to Consider
argenx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals (AMRX - Free Report) and Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy) each, while AC Immune (ACIU - Free Report) carries a Zacks Rank #2 (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 Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX's shares have risen 46.2% year to date.
Amneal Pharmaceuticals' earnings beat in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for Precigen’s 2026 have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN's shares have increased 56.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU's shares have declined 19.4% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.