IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

Rhea-AI Impact

(High)

Rhea-AI Sentiment

(Positive)

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) reported pivotal Phase 2/3 ENERGY data for IMAAVY (nipocalimab-aahu) in warm autoimmune hemolytic anemia, a disease with no FDA-approved therapies. The 30 mg/kg group achieved statistically significant durable hemoglobin response and about three times more responders than placebo by 24 weeks.

Mean hemoglobin rose ≥1 g/dL by Week 1, nearly two-thirds met stringent hemoglobin targets by Week 24, fatigue and corticosteroid use improved, safety matched the existing profile, and the sBLA has FDA Priority Review.

AI-generated analysis. Not financial advice.

Positive

Approximately three times more patients achieved durable hemoglobin response vs placebo by Week 24 (30 mg/kg)
Mean hemoglobin increase of at least 1 g/dL at Week 1 in 30 mg/kg group
Nearly two-thirds of patients met both ≥10 g/dL and ≥2 g/dL hemoglobin targets by Week 24
FACIT-Fatigue score improved by a mean 3.51 points over placebo at Week 24
Mean corticosteroid dose reduced 15% vs 4% with placebo at Week 24
Supplemental BLA for IMAAVY in wAIHA granted U.S. FDA Priority Review

Negative

IMAAVY is not approved for the treatment of warm autoimmune hemolytic anemia
Common adverse reactions ≥10% included peripheral edema, diarrhea and fever in wAIHA patients
Some endpoints, including early hemoglobin change, were not part of the hierarchical testing procedure

News Market Reaction – JNJ

-0.07%

1 alert

-0.07% News Effect

On the day this news was published, JNJ declined 0.07%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Dose level: 30 mg/kg IV every four weeks Early Hgb improvement: 1 g/dL increase at Week 1 Durable Hgb criteria: Hgb ≥10 g/dL and ≥2 g/dL increase +5 more

8 metrics

Dose level 30 mg/kg IV every four weeks ENERGY Phase 2/3 wAIHA treatment group; dose submitted to FDA

Early Hgb improvement 1 g/dL increase at Week 1 Mean hemoglobin improvement in 30 mg/kg group vs placebo

Durable Hgb criteria Hgb ≥10 g/dL and ≥2 g/dL increase Primary endpoint definition over ≥28 days from Week 16

FACIT-Fatigue change 3.51-point improvement over placebo Mean change at Week 24 for 30 mg/kg group

Steroid reduction – active 15% reduction from baseline dose Mean corticosteroid dose reduction at Week 24, 30 mg/kg

Steroid reduction – placebo 4% reduction from baseline dose Mean corticosteroid dose reduction at Week 24, placebo

Common adverse reactions ≥10% incidence Peripheral edema, diarrhea and fever in wAIHA patients

Threefold response rate ≈3x more patients with durable Hgb ENERGY trial 30 mg/kg vs placebo by 24 weeks

Market Reality Check

Price: $235.18 Vol: Volume 8,090,953 is close...

normal vol

$235.18 Last Close

Volume Volume 8,090,953 is close to the 20-day average of 7,893,287, suggesting typical trading interest into this update. normal

Technical Shares at $238.49 are trading above the $213.98 200-day MA and about 5.25% below the 52-week high of $251.71.

Peers on Argus

JNJ gained 0.63% while major pharma peers were mostly lower (e.g., ABBV, AZN, LL...

JNJ gained 0.63% while major pharma peers were mostly lower (e.g., ABBV, AZN, LLY, NVS down; NVO up), pointing to a stock-specific response rather than a broad sector move.

Previous Clinical trial Reports

5 past events · Latest: Jun 03 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jun 03	SLE Phase 2 data	Positive	+0.2%	Nipocalimab met primary endpoint in Phase 2 SLE JASMINE study.
May 05	Robotic surgery study	Positive	+0.6%	OTTAVA robotic system met safety and performance endpoints in gastric bypass.
Apr 10	IOL vision outcomes	Positive	-1.2%	TECNIS PureSee IOL showed strong vision, high spectacle independence and satisfaction.
Mar 03	SLE Fast Track	Positive	-0.7%	Nipocalimab received FDA Fast Track designation for systemic lupus erythematosus.
Jan 06	SLE topline results	Positive	+0.2%	Phase 2b JASMINE topline showed primary endpoint met and no new safety signals.

Pattern Detected

Recent clinical and device trial news has produced small mixed price reactions, with both modest gains and declines following generally positive data.

Recent Company History

Over recent months, JNJ has released multiple clinical trial updates across immunology and medical devices. Nipocalimab data in systemic lupus erythematosus and its Fast Track designation, pivotal robotic surgery results for the OTTAVA system, and vision outcomes for the TECNIS PureSee IOL all showed positive efficacy or safety signals. Price moves around these events ranged from about -1.18% to 0.60%. Today’s warm autoimmune hemolytic anemia data extend this pattern of generally favorable trial readouts with only modest stock reactions.

Historical Comparison

-0.2% avg move · In the past 12 months, JNJ released 5 clinical trial updates with an average move of -0.18%, suggest...

clinical trial

-0.2%

Average Historical Move clinical trial

In the past 12 months, JNJ released 5 clinical trial updates with an average move of -0.18%, suggesting historically muted stock reactions to similar data.

Clinical updates span autoimmune (nipocalimab in SLE), surgical robotics (OTTAVA) and ophthalmology (TECNIS PureSee IOL), indicating steady progression from Phase 2 data to pivotal studies and device-focused outcomes.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-11

JNJ has an effective S-3ASR shelf registration dated 2026-02-11, allowing it to issue unsecured debt securities from time to time under an existing indenture, with terms and use of proceeds detailed in future prospectus supplements.

Market Pulse Summary

This announcement highlights statistically significant Phase 2/3 results for IMAAVY in warm autoimmu...

Analysis

This announcement highlights statistically significant Phase 2/3 results for IMAAVY in warm autoimmune hemolytic anemia, including rapid hemoglobin gains and steroid-sparing effects at a 30 mg/kg dose. It extends JNJ’s series of generally positive clinical updates across immunology and other platforms. Investors may watch upcoming EHA 2026 presentations, the ongoing FDA Priority Review of the sBLA, and any future regulatory or label-expansion steps to understand longer-term impact.

Key Terms

phase 2/3, biologics license application, priority review, immunoglobulin g (igg), +3 more

7 terms

phase 2/3 medical

"first comprehensive results from the Phase 2/3 ENERGY study showing that IMAAVY"

A phase 2/3 trial is a combined clinical study that first evaluates how well a treatment works and the best dose, then expands into a larger test to confirm those results and safety. For investors, it matters because moving into a phase 2/3 signals that an experimental therapy has shown initial promise and will be tested at scale, which can materially change the odds and timeline for regulatory approval and commercial potential.

biologics license application regulatory

"These data support the supplemental Biologics License Application (sBLA) for IMAAVY"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

priority review regulatory

"has since been granted U.S. FDA Priority Review."

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

immunoglobulin g (igg) medical

"designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm"

Immunoglobulin G (IgG) is the most abundant antibody the body makes to spot and neutralize germs and to remember past infections; think of it as the immune system’s long-term security cameras and memory cards. For investors, IgG matters because tests that measure IgG, medicines built from or mimicking IgG, and engineered IgG therapies are common products in diagnostics, vaccines and biopharma pipelines, influencing clinical results, regulatory decisions and potential revenues.

facit-fatigue medical

"Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 24"

A standardized questionnaire that measures how tired patients feel and how fatigue affects their daily life; think of it as a patient-reported “fatigue thermometer.” It’s widely used in clinical trials and regulatory submissions to quantify treatment benefit beyond lab tests. Investors watch FACIT-Fatigue scores because improvements can support drug approvals, label claims or market differentiation, which may influence a therapy’s commercial value and adoption.

fcrn blocker medical

"first and only investigational FcRn blocker with potential to reduce systemic"

A fcrn blocker is a type of drug that interferes with the neonatal Fc receptor, a body ‘recycling’ system that preserves antibodies in the blood; by blocking it, the medicine lowers overall antibody levels, including harmful ones. Investors care because these drugs can treat a range of autoimmune and antibody-driven disorders; success or failure in clinical trials, regulatory approvals, or pricing can strongly affect a developer’s commercial prospects and valuation, much like a new technology that cuts demand for a common resource.

autoantibodies medical

"targets the underlying autoantibodies driving disease while preserving key immune"

Autoantibodies are proteins made by the immune system that mistakenly target a person’s own tissues, like friendly fire where soldiers attack their own team. They matter to investors because their presence influences diagnosis, disease progression, and patient safety, which can affect demand for drugs, diagnostic tests, trial outcomes, regulatory decisions, and potential liabilities in healthcare-related companies.

AI-generated analysis. Not financial advice.

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06/11/2026 - 02:03 AM

Patients in the IMAAVY 30 mg/kg treatment group^a achieved statistically significant durable hemoglobin response^b, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1^c
More patients treated with IMAAVY experienced improvement in fatigue^d and corticosteroid dose reductions^e
IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function
Pivotal results will be presented at EHA 2026

STOCKHOLM, June 11, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today is presenting the first comprehensive results from the Phase 2/3 ENERGY study showing that IMAAVY^® (nipocalimab-aahu) produced a statistically significant durable hemoglobin (Hgb) response^b with rapid onset of effect in patients with warm autoimmune hemolytic anemia (wAIHA)^ein the 30 mg/kg treatment group,^a compared with those who received placebo. The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. Overall, patients treated with this dose of IMAAVY showed a mean Hgb improvement of at least 1g/dL as early as Week 1.¹^,c

To be presented at the European Hematology Association (EHA) 2026 Congress, these results mark an important step forward for people living with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options.

"These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells in people living with warm autoimmune hemolytic anemia," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.^g "Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience."

Key findings from the Phase 2/3 ENERGY study
The ENERGY study compared IMAAVY to placebo in achieving the primary endpoint of durable Hgb improvement, which was defined as achieving the following stringent criteria¹:

An increase from baseline in Hgb ≥2 g/dL
Hgb concentration ≥10 g/dL
For at least three visits (≥28 days, where criteria was met, starting by Week 16)
Without the need for rescue therapy or changes to background medications for wAIHA

In the 30 mg/kg treatment group, a mean increase of 1 g/dL in Hgb was observed at Week 1, compared to no change in the placebo group.^c In wAIHA, treatment also aims to maintain Hgb ≥10 g/dL and achieve a ≥2 g/dL increase from baseline and nearly two-thirds of patients achieved both of these targets by Week 24.

IMAAVY was also associated with improvements in fatigue^d and reduction in steroid use^f, two key secondary endpoints. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.^d

In the study, IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in the approved indication of generalized myasthenia gravis. The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and fever.

By targeting the pathogenic IgG autoantibodies that lead to red blood cell destruction in wAIHA, IMAAVY is designed to utilize a differentiated, immunoselective approach, preserving underlying key humoral immune functions in a condition where many patients currently can only rely on unapproved therapies, including corticosteroids and broad immunosuppressants.²

"In the first large, placebo-controlled trial of its kind, IMAAVY delivered durable improvements in hemoglobin levels and showed no new safety signals, in a disease with no FDA-approved therapies," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "This immunoselective approach targets the underlying autoantibodies driving disease while preserving key immune functions, which is important for people living with this disease who frequently suffer with comorbid conditions."

These data support the supplemental Biologics License Application (sBLA) for IMAAVY which has since been granted U.S. FDA Priority Review.

Editor's Notes:

a. The dose submitted to the FDA for approval (30 mg/kg IV every four weeks).
b. Durable hemoglobin response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy. This endpoint was prespecified within the equal-weight hierarchical testing procedure; the resulting one-sided p-value was considered statistically significant in accordance with the predefined multiplicity control strategy.
c. These data were not a part of the hierarchical testing procedure.
d. Based on mean change from baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 24, a key secondary endpoint, with mean change of 3.51 points over placebo for 30 mg/kg IV treatment group (dose filed with the FDA). This endpoint was prespecified within the hierarchical testing procedure; the resulting one-sided p-value was considered nominal in accordance with the predefined multiplicity control strategy.
e. IMAAVY is not approved for the treatment of warm autoimmune hemolytic anemia.
f. Participants who achieved durable Hgb response were required to initiate corticosteroid (CS) dose tapering. Doses were reduced by 10% of the baseline CS dose every two weeks, provided Hgb levels did not decline by ≥1 g/dL. At Week 24, the mean percent reduction in CS dose was numerically higher in the nipocalimab 30 mg/kg treatment group (15% reduction from baseline dose) compared with placebo (4% reduction from baseline dose). This endpoint was prespecified within the hierarchical testing procedure.
g. Dr. Bruno Fattizzo is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

ABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA). 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo. Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment.³

ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.⁴ Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.⁴^,⁵ This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.⁵^,⁶ Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.⁷

There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.⁴ With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.⁷

ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY^® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.⁸

Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus. ³^,⁹^,¹⁰^,¹¹^,¹²^,¹³^,¹⁴^,¹⁵^,¹⁶^,¹⁷

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025
U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026
U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, generalized myasthenia gravis (gMG) in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024
U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026

The legal manufacturer for IMAAVY is Janssen Biotech, Inc.

WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

It is not known if IMAAVY is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMAAVY?

IMAAVY is a prescription medicine that may cause serious side effects, including:

Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:

fever
chills
shivering
cough

sore throat
fever blisters
burning when you urinate

Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:

a swollen face, lips, mouth, tongue, or throat
difficulty swallowing or breathing

itchy rash (hives)
chest pain or tightness

Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion:

headache
rash
nausea
fatigue

dizziness
chills
flu-like symptoms
redness of skin

Do not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.

Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:

ever had an allergic reaction to IMAAVY.
have or had any recent infections or symptoms of infection.
have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.
are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.

Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"

The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.

Janssen Biotech, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

¹ Fattizzo B, Murakhovskaya I, Ueda.Y, Schlichting D, Sweet K, Zelasky M, Craig J, Liva S, Leu J, Ling L, Pease S, Anakor A, Shu C, Nipocalimab for warm autoimmune hemolytic anemia: results from the Phase 2/3 randomized, double-blind ENERGY study, Presented at EHA 2026 Congress, Available at https://library.ehaweb.org/eha/2026/eha-2026/4206854/bruno.fattizzo.nipocalimab.for.warm.autoimmune.hemolytic.anemia.results.from.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3DS300
² Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1). https://doi.org/10.1080/19420862.2025.2461191
³ ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2026.
⁴ National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: June 2026.
⁵ Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
⁶ Cherif, H, Cai, Q, Crivera, C, Leon, A, Rahman, I, Leval, A, Noel, W and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol. https://doi.org/10.1111/ejh.14311.
⁷ Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
⁸ IMAAVY^® U.S. Prescribing Information.
⁹ ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
¹⁰ ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
¹¹ ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
¹² ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
¹³ ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
¹⁴ ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
¹⁵ ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
¹⁶ ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
¹⁷ ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.

Media contact:	Investor contact:
Bridget Kimmel	Jess Margevich
BKimmel@ITS.JNJ.com	Investor-relations@its.jnj.com

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SOURCE Johnson & Johnson

FAQ

What were the key results of Johnson & Johnson (JNJ) IMAAVY Phase 2/3 ENERGY trial in wAIHA?

The ENERGY trial showed statistically significant durable hemoglobin response with IMAAVY 30 mg/kg versus placebo. According to Johnson & Johnson, about three times as many patients achieved durable hemoglobin levels by 24 weeks, in a disease with no current FDA-approved therapies.

How quickly did IMAAVY (nipocalimab-aahu) improve hemoglobin in Johnson & Johnson's wAIHA study?

IMAAVY produced a mean hemoglobin increase of at least 1 g/dL by Week 1. According to Johnson & Johnson, this early improvement occurred in the 30 mg/kg group, while the placebo group showed no hemoglobin change at that time point.

How did IMAAVY affect fatigue and steroid use in the Phase 2/3 wAIHA ENERGY trial (JNJ)?

IMAAVY was associated with reduced fatigue and lower corticosteroid use over 24 weeks. According to Johnson & Johnson, FACIT-Fatigue scores improved by a mean 3.51 points over placebo and mean corticosteroid dose fell 15% versus 4% with placebo at Week 24.

What safety profile did IMAAVY show in Johnson & Johnson's wAIHA Phase 2/3 ENERGY study?

IMAAVY showed a safety profile consistent with its approved use in generalized myasthenia gravis. According to Johnson & Johnson, the most common adverse reactions (≥10%) in wAIHA patients were peripheral edema, diarrhea and fever, with no new safety signals reported.

What does FDA Priority Review of the IMAAVY sBLA mean for Johnson & Johnson (NYSE: JNJ) in wAIHA?

The IMAAVY supplemental BLA in wAIHA has been granted FDA Priority Review. According to Johnson & Johnson, this regulatory step is supported by ENERGY trial data, though the company does not provide details on review timelines or potential approval outcomes.

What proportion of patients reached key hemoglobin targets with IMAAVY in Johnson & Johnson's wAIHA trial?

Nearly two-thirds of patients on IMAAVY 30 mg/kg achieved both main hemoglobin targets by Week 24. According to Johnson & Johnson, these targets were hemoglobin ≥10 g/dL and an increase of ≥2 g/dL from baseline, without rescue therapy.

Is IMAAVY currently approved for warm autoimmune hemolytic anemia treatment in the United States?

IMAAVY is not approved for treating warm autoimmune hemolytic anemia in the U.S. According to Johnson & Johnson, the Phase 2/3 ENERGY data support a supplemental BLA for wAIHA, which has received FDA Priority Review but has not yet resulted in approval.