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J&J's Imaavy Gets FDA Approval as the First Treatment for wAIHA
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Key Takeaways
Johnson & Johnson's Imaavy is the first FDA-approved treatment specifically indicated for wAIHA.
Imaavy delivered significantly higher durable hemoglobin responses and rapid gains versus placebo.
The wAIHA approval gives Imaavy an additional commercial opportunity beyond its use in gMG.
Johnson & Johnson (JNJ - Free Report) announced that the FDA has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 years and above who are currently or have been previously treated with corticosteroids.
The approval makes Imaavy the first FDA-approved treatment specifically indicated for wAIHA, a rare and potentially life-threatening autoimmune disease. A rare and potentially life-threatening disease, wAIHA is a condition in which autoantibodies attack and destroy red blood cells, resulting in severe anemia and debilitating fatigue.
Imaavy is currently approved for treating generalized myasthenia gravis (gMG), a chronic, incurable autoimmune condition. While the FDA approved Imaavy in April 2025, it was approved in the EU in December 2025.
Year to date, shares of J&J have rallied 33.4% compared with the industry’s increase of 19.8%.
Image Source: Zacks Investment Research
Data Supporting the Latest Nod for JNJ’s Imaavy
The latest approval was based on data from the pivotal phase II/III ENERGY study, which evaluated Imaavy against placebo in patients with wAIHA.
Data from the same study showed that patients who received the approved 30 mg/kg dose of Imaavy achieved a significantly higher rate of durable hemoglobin response compared with placebo. Also, approximately three times as many patients receiving the approved Imaavy dose achieved durable hemoglobin levels by week 24 versus placebo.
Imaavy also demonstrated a rapid treatment effect, with patients in the approved-dose group experiencing a mean hemoglobin increase of 1 g/dL as early as week 1. Additionally, patients treated with Imaavy showed a 3.5-point greater mean improvement in FACIT-Fatigue scores at week 24 compared with placebo, indicating an improvement in fatigue.
The latest FDA approval in wAIHA marks an important milestone for J&J’s immunology portfolio and provides Imaavy with an additional commercial opportunity beyond its existing use in gMG. On the second-quarter 2026 conference call, management said that it is seeing a strong launch for Imaavy in gMG.
Nipocalimab, an FcRn blocker, is also being evaluated for various immune-mediated conditions. It is in late-stage studies for hemolytic disease of the fetus and newborn, systemic lupus erythematosus and Sjogren’s disease, and in mid-stage studies for idiopathic inflammatory myopathy. J&J believes that nipocalimab has pipeline-in-a-product potential.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.9% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 122.1% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
View the Zacks #1 Rank List
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J&J's Imaavy Gets FDA Approval as the First Treatment for wAIHA
Key Takeaways
Johnson & Johnson (JNJ - Free Report) announced that the FDA has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 years and above who are currently or have been previously treated with corticosteroids.
The approval makes Imaavy the first FDA-approved treatment specifically indicated for wAIHA, a rare and potentially life-threatening autoimmune disease. A rare and potentially life-threatening disease, wAIHA is a condition in which autoantibodies attack and destroy red blood cells, resulting in severe anemia and debilitating fatigue.
Imaavy is currently approved for treating generalized myasthenia gravis (gMG), a chronic, incurable autoimmune condition. While the FDA approved Imaavy in April 2025, it was approved in the EU in December 2025.
Year to date, shares of J&J have rallied 33.4% compared with the industry’s increase of 19.8%.
Image Source: Zacks Investment Research
Data Supporting the Latest Nod for JNJ’s Imaavy
The latest approval was based on data from the pivotal phase II/III ENERGY study, which evaluated Imaavy against placebo in patients with wAIHA.
Data from the same study showed that patients who received the approved 30 mg/kg dose of Imaavy achieved a significantly higher rate of durable hemoglobin response compared with placebo. Also, approximately three times as many patients receiving the approved Imaavy dose achieved durable hemoglobin levels by week 24 versus placebo.
Imaavy also demonstrated a rapid treatment effect, with patients in the approved-dose group experiencing a mean hemoglobin increase of 1 g/dL as early as week 1. Additionally, patients treated with Imaavy showed a 3.5-point greater mean improvement in FACIT-Fatigue scores at week 24 compared with placebo, indicating an improvement in fatigue.
The latest FDA approval in wAIHA marks an important milestone for J&J’s immunology portfolio and provides Imaavy with an additional commercial opportunity beyond its existing use in gMG. On the second-quarter 2026 conference call, management said that it is seeing a strong launch for Imaavy in gMG.
Nipocalimab, an FcRn blocker, is also being evaluated for various immune-mediated conditions. It is in late-stage studies for hemolytic disease of the fetus and newborn, systemic lupus erythematosus and Sjogren’s disease, and in mid-stage studies for idiopathic inflammatory myopathy. J&J believes that nipocalimab has pipeline-in-a-product potential.
JNJ’s Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , which sports a Zacks Rank #1 (Strong Buy) and Anika Therapeutics (ANIK - Free Report) , which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.9% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 122.1% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.