Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

Rhea-AI Impact

(High)

Rhea-AI Sentiment

(Neutral)

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) submitted an sBLA to the FDA on Feb 24, 2026, seeking approval of IMAAVY (nipocalimab) as the first treatment for warm autoimmune hemolytic anemia (wAIHA).

Phase 2/3 ENERGY showed a rapid, durable hemoglobin response and improved fatigue versus placebo; IMAAVY was generally well tolerated. Full ENERGY results are forthcoming.

Positive

Durable hemoglobin response achieved versus placebo in ENERGY
Rapid fatigue improvement measured by FACIT-Fatigue
sBLA submission seeking first-ever wAIHA approval
Favorable tolerability with no new safety signals reported

Negative

Regulatory uncertainty — FDA review and approval are pending
Full ENERGY results remain forthcoming, limiting complete assessment
Not approved in wAIHA yet per company disclosure

Key Figures

wAIHA prevalence: 1 in 8,000 Mortality risk increase: 20–30% higher risk of death Hemoglobin threshold: ≥10 g/dL +3 more

6 metrics

wAIHA prevalence 1 in 8,000 Estimated prevalence of warm autoimmune hemolytic anemia in the U.S.

Mortality risk increase 20–30% higher risk of death Increased mortality reported for people living with wAIHA

Hemoglobin threshold ≥10 g/dL Component of durable hemoglobin response definition in ENERGY trial

Hemoglobin increase ≥2 g/dL Required rise from baseline for durable response in ENERGY trial

Response duration 28 days Minimum period hemoglobin criteria must be maintained without rescue therapy

Age threshold 12 years and older IMAAVY’s existing U.S. approval population in gMG

Market Reality Check

Price: $245.84 Vol: Volume 9,013,581 is close...

normal vol

$245.84 Last Close

Volume Volume 9,013,581 is close to 20-day average 9,370,613 with relative volume at 0.96x. normal

Technical Shares at $245.84 are trading above the 200-day MA of $186.07 and within 1% of the 52-week high of $246.96.

Peers on Argus

Large-cap pharma peers show mixed but mostly positive moves today (e.g., ABBV +1...

Large-cap pharma peers show mixed but mostly positive moves today (e.g., ABBV +1.58%, LLY +1.10%, NVO -1.39%), while scanner momentum data flags JNJ’s move as stock-specific rather than a broad sector rotation.

Common Catalyst Peer news flow is light, with only ABBV highlighted for a conference appearance, suggesting today’s JNJ move is more tied to its own pipeline updates than a shared catalyst.

Previous Fda approval Reports

5 past events · Latest: Feb 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	FDA dosing approval	Positive	-0.1%	FDA approved monthly RYBREVANT FASPRO schedule with comparable efficacy and safety.
Dec 18	Device indication approval	Positive	-1.0%	FDA expanded TRUFILL n‑BCA indication for treating symptomatic cSDH via MMA embolization.
Dec 17	Subcutaneous EGFR therapy	Positive	-1.0%	FDA approved first SC RYBREVANT FASPRO formulation for EGFR‑mutated NSCLC with shorter admin time.
Dec 13	Oncology drug approval	Positive	+1.2%	FDA approved AKEEGA plus prednisone for BRCA2‑mutated mCSPC with 54% risk reduction.
Nov 06	Psychiatry drug approval	Positive	+0.5%	FDA approved CAPLYTA as adjunctive MDD therapy based on positive Phase 3 data.

Pattern Detected

Recent FDA approval headlines for JNJ often saw modest or negative next-day moves, with an average move of -0.05%, indicating approvals have not consistently driven strong upside.

Recent Company History

Across the past few FDA approval events, Johnson & Johnson secured label expansions and new indications in oncology, neurology, and interventional medicine, including RYBREVANT FASPRO, TRUFILL n‑BCA, AKEEGA, and CAPLYTA. Price reactions were mixed, ranging from small declines around -0.96% to gains of +1.22%. Today’s sBLA filing for IMAAVY in wAIHA fits a pattern of incremental pipeline strengthening across multiple therapeutic areas rather than a single transformative catalyst.

Historical Comparison

-0.1% avg move · In the past five FDA approval headlines, JNJ’s average next‑day move was -0.05% with mixed reactions...

fda approval

-0.1%

Average Historical Move fda approval

In the past five FDA approval headlines, JNJ’s average next‑day move was -0.05% with mixed reactions. Today’s positive move of +1.38% on an sBLA filing for IMAAVY is somewhat stronger than that typical pattern.

The fda approval history shows JNJ broadening its portfolio across oncology, neurology, and interventional devices; today’s sBLA for IMAAVY in wAIHA extends this regulatory momentum into rare autoimmune hematology.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-11

An effective S-3ASR shelf filed on 2026-02-11 allows Johnson & Johnson to issue unsecured debt securities over time, with terms set in future prospectus supplements. Proceeds may be used for general corporate purposes, including working capital, capex, buybacks, refinancing, or acquisitions.

Market Pulse Summary

This announcement highlights a significant regulatory step for IMAAVY in warm autoimmune hemolytic a...

Analysis

This announcement highlights a significant regulatory step for IMAAVY in warm autoimmune hemolytic anemia, a rare disease with no approved therapies and a 20–30% higher risk of death. The sBLA rests on Phase 2/3 ENERGY data showing durable hemoglobin responses and fatigue improvement. In context, JNJ has recently logged multiple FDA approval wins across oncology and neuroscience, while also maintaining capital flexibility through an effective S-3ASR debt shelf. Investors may watch for full ENERGY results and FDA review outcomes.

Key Terms

supplemental biologics license application, immunoglobulin g (igg), phase 2/3, randomized, double-blind, placebo-controlled, +2 more

6 terms

supplemental biologics license application regulatory

"announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food"

A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.

immunoglobulin g (igg) medical

"wAIHA occurs when harmful immunoglobulin G (IgG) autoantibodies attach to and destroy red blood"

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.

phase 2/3 medical

"supported by the Phase 2/3 ENERGY multicenter, randomized, double-blind, placebo-controlled study"

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.

randomized, double-blind, placebo-controlled medical

"ENERGY multicenter, randomized, double-blind, placebo-controlled study (NCT04119050) evaluating"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

facit-fatigue medical

"improvement in fatigue as assessed by FACIT-Fatigue, an outcome of significant importance"

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.

generalized myasthenia gravis medical

"approved in the United States in April 2025 for the treatment of generalized myasthenia gravis (gMG)"

A chronic neurological condition in which the immune system disrupts the chemical signals between nerves and muscles, causing muscle weakness that typically fluctuates and worsens with activity. Think of it as a faulty light switch or loose wiring that prevents muscles from responding reliably; severity and daily variability make treatment and long-term management important. For investors, the condition matters because it defines patient need, market size, and demand for approved therapies, clinical trial outcomes, and reimbursement decisions that drive company valuation.

AI-generated analysis. Not financial advice.

02/24/2026 - 04:03 PM

Data from the pivotal ENERGY trial showed IMAAVY^® produced a rapid and durable hemoglobin response^a in wAIHA

Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia

SPRING HOUSE, Pa., Feb. 24, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), seeking approval of IMAAVY^® (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune hemolytic anemia (wAIHA).^b This rare and serious autoantibody disease affects approximately 1 in 8,000 in the United States and currently has no approved treatments despite substantial unmet need.¹ The condition is associated with significant morbidity and mortality, with those living with the disease found to experience a 20-30% higher risk of death.²

"People living with warm autoimmune hemolytic anemia face a serious, life-threatening disease with no approved treatment options and a high risk of complications, including profound chronic fatigue, transfusion dependence, and organ failure," said David M Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The submission of this sBLA represents an important milestone for the wAIHA community and underscores our commitment to advancing targeted, immunoselective therapies that can deliver meaningful, rapid improvement for these patients."

wAIHA occurs when harmful immunoglobulin G (IgG) autoantibodies attach to and destroy red blood cells – leading to anemia.³ IMAAVY^® is designed to selectively block the neonatal Fc receptor (FcRn), a key regulator of IgG recycling.⁴ By reducing circulating IgG, including autoantibodies, IMAAVY^® targets the underlying cause of disease while preserving critical immune functions, including some humoral B-cell responses to new infections.

The sBLA submission is supported by the Phase 2/3 ENERGY multicenter, randomized, double-blind, placebo-controlled study (NCT04119050) evaluating IMAAVY^® in adults living with wAIHA. The data showed that more patients treated with nipocalimab achieved the stringent primary endpoint of a durable hemoglobin response compared with placebo. A durable response was defined as achieving a hemoglobin level above 10 g/dL and an increase of at least 2 g/dL for at least 28 days, without the need for rescue therapy.⁵

In addition to a rapid and durable improvement in hemoglobin, more patients treated with IMAAVY^® experienced rapid and sustained improvement in fatigue as assessed by FACIT-Fatigue, an outcome of significant importance to people living with wAIHA.⁵

"The ENERGY study demonstrated clinically meaningful results in adults living with warm autoimmune hemolytic anemia," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, Università degli Studi di Milano.^c "These results provide a strong rationale for the potential of IMAAVY to rapidly improve fatigue and provide durable hemoglobin response while maintaining favorable tolerability."

IMAAVY^® was generally well tolerated in ENERGY, with no new safety signals identified and a safety profile consistent with the IMAAVY^® label.⁵^,6 IMAAVY^® was approved in the United States in April 2025 for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive.⁶

The full results of the ENERGY trial are forthcoming.

Editor's notes:
	a.	Durable hemoglobin response = hemoglobin concentration ≥10 g/dL and an increase from baseline in Hgb ≥2 g/dL for at least 28 days
	b.	IMAAVY^® is not approved in wAIHA
	c.	Dr. Fattizzo has served as a consultant to J&J; he has not been paid 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 wAIHA.⁵

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. 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.¹^,7This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.^8,9Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.¹⁰

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.⁷ With an unmet need for treatment in wAIHA, novel therapies like nipocalimab that can deliver meaningful improvement to patients is critical.⁹

ABOUT IMAAVY^® (nipocalimab-aahu)
IMAAVY^® is an immunoselective treatment designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions. IMAAVY^® is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.⁶

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.^{11,12,13,14,15,16,17,18,19,20}

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

U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia) FNAIT in March 2024 and Sjögren's disease (SjD) in March 2025
U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, 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
EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025

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:

o fever

o chills

o shivering

o cough

o sore throat

o fever blisters

o 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:

o a swollen face, lips, mouth, tongue, or throat

o difficulty swallowing or breathing

o itchy rash (hives)

o 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:

o headache

o rash

o nausea

o fatigue

o dizziness

o chills

o flu-like symptoms

o 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 Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies.

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 nipocalimab. 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 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.



¹ 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.
² Jackson L, Zhdanava M, Pesa J, Boonmak P, Chen G, Liu D, et al. Mortality associated with warm autoimmune hemolytic anemia among Medicare beneficiaries. Blood. 2025;2694, 146 (Suppl 1):2694. https://doi.org/10.1182/blood-2025-2694
³ National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: February 2026.
⁴ Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
⁵ ClinicalTrials.gov Identifier: NCT04119050. Available at: https://www.clinicaltrials.gov/study/NCT04119050
⁶ IMAAVY^® U.S. Prescribing Information.
⁷ Sudulagunta SR, et al. Warm Autoimmune Hemolytic Anemia: Clinical Profile and Management. J Hematol. 2017 Mar; 6(1): 12–20. Published online 2017 Mar 21. doi: 10.14740/jh303w.
⁸ National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: February 2026.
⁹ Cherif H, Cai ., Crivera, C, Leon A, Rahman I, Leval A, Noel W, Kjellander C. Overall survival and treatment patterns among patients with warm wutoimmune hemolytic anemia in Sweden: A nationwide population-based. 2024.
¹⁰ Fattizzo B, Barcellini W. New therapies for the treatment of warm autoimmune hemolytic anemia. Transfusion Medical Reviews. 2022;36(4). https://doi.org/10.1016/j.tmrv.2022.08.001
¹¹ ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: February 2026.
¹² ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: February 2026.
¹³ ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: February 2026.
¹⁴ ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: February 2026.
¹⁵ ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: February 2026.
¹⁶ ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: February 2026.
¹⁷ ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: February 2026.
¹⁸ ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: February 2026.
¹⁹ ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: February 2026.
²⁰ ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: February 2026.

Media contact:
Bridget Kimmel
bkimmel@its.jnj.com

Investor contact:
Lauren Johnson
investor-relations@its.jnj.com

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SOURCE Johnson & Johnson

FAQ

What did Johnson & Johnson announce about IMAAVY (JNJ) on February 24, 2026?

They submitted a supplemental BLA to the FDA seeking approval of IMAAVY for wAIHA. According to the company, Phase 2/3 ENERGY showed a rapid, durable hemoglobin response and improved fatigue versus placebo, and full trial results are forthcoming.

What were the key clinical findings from the ENERGY trial for IMAAVY (JNJ)?

ENERGY showed more patients on nipocalimab achieved durable hemoglobin response versus placebo. According to the company, durable response was Hgb ≥10 g/dL plus ≥2 g/dL increase for ≥28 days, with rapid fatigue improvements observed.

How does IMAAVY (JNJ) work to treat warm autoimmune hemolytic anemia?

IMAAVY selectively blocks the neonatal Fc receptor (FcRn) to reduce circulating IgG autoantibodies. According to the company, this reduces pathogenic IgG while preserving key humoral immune functions.

Is IMAAVY (JNJ) already approved for wAIHA and what is the regulatory status?

IMAAVY is not yet approved for wAIHA; an sBLA was submitted on Feb 24, 2026. According to the company, FDA review is pending and final approval has not been granted.

What safety information did Johnson & Johnson report for IMAAVY in ENERGY?

IMAAVY was generally well tolerated with no new safety signals identified in ENERGY. According to the company, the observed safety profile was consistent with the existing IMAAVY label from other indications.

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)