An Expert Report on Nipocalimab (Imaavy™): Mechanism, Clinical Development, and Strategic Positioning

Executive Summary

Nipocalimab, marketed under the brand name Imaavy™, represents a significant advancement in the treatment of immunoglobulin G (IgG)-mediated diseases. As a fully human, aglycosylated, effectorless monoclonal antibody, it operates by selectively blocking the neonatal Fc receptor (FcRn), a critical regulator of IgG homeostasis. Its molecular design, particularly its high-affinity, pH-independent binding to FcRn, distinguishes it within its therapeutic class and underpins a broad and ambitious clinical development program.

This report provides a comprehensive analysis of Nipocalimab, from its fundamental pharmacology to its clinical trial portfolio, recent regulatory approval, and strategic market positioning. The cornerstone of its clinical success to date is the landmark U.S. Food and Drug Administration (FDA) approval for generalized myasthenia gravis (gMG) in both adult and adolescent populations, granting it the broadest label in the FcRn inhibitor class at the time of its launch. This approval was based on the robust efficacy and safety data from the pivotal Phase 3 Vivacity-MG3 study, which demonstrated statistically significant and clinically meaningful improvements in disease activity and muscle strength, with evidence of long-term sustained disease control.

Beyond gMG, Johnson & Johnson is leveraging Nipocalimab's unique mechanism to build a "pipeline-in-a-product." The development strategy is notably differentiated by its focus on maternal-fetal alloimmune diseases, such as hemolytic disease of the fetus and newborn (HDFN), where Nipocalimab's ability to block transplacental IgG transfer offers a novel, non-surgical therapeutic approach. This has been validated by a Breakthrough Therapy Designation from the FDA based on promising Phase 2 data. The program also extends to other rare autoantibody conditions like warm autoimmune hemolytic anemia (wAIHA) and prevalent rheumatologic diseases, including Sjögren's disease, where it has also received Breakthrough Therapy Designation following positive Phase 2 results.

In the competitive landscape, Nipocalimab enters a market with established FcRn blockers. Johnson & Johnson's strategy appears focused on differentiating Imaavy™ through its broad initial label, its unique potential in maternal-fetal medicine, and a clinical narrative centered on sustained disease control with a predictable, non-cyclic dosing regimen. The success of this franchise will be contingent on continued positive outcomes from its ongoing pivotal trials, effective commercial execution, and successful navigation of an increasingly competitive therapeutic space.

Introduction to Nipocalimab and the Neonatal Fc Receptor (FcRn) Pathway

Nipocalimab: A Differentiated Molecular Profile

Nipocalimab is a highly specialized biologic therapy classified as a fully human, recombinant, aglycosylated, effectorless immunoglobulin G1 lambda (IgG1λ) monoclonal antibody.[1] Its chemical identity is defined by the CAS Number 2211985-36-1, and it is cataloged in the DrugBank database under the identifier DB16257.[1] The approximate molecular weight of this complex protein is 142 kDa.[1]

The molecular engineering of Nipocalimab is critical to its function and safety profile. Being "aglycosylated" and "effectorless" means that the Fc region of the antibody has been modified to prevent it from engaging with other immune system components that would typically trigger inflammatory responses. Specifically, this design abrogates its ability to induce antibody-dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC), which are undesirable effects for a therapy intended to suppress a specific arm of the immune system.[1]

The drug's development history traces back to Momenta Pharmaceuticals, where it was developed under the codename M281. In a strategic acquisition to bolster its immunology pipeline, Johnson & Johnson acquired Momenta Pharmaceuticals in August 2020 and has since managed the late-stage development and commercialization of Nipocalimab through its Janssen pharmaceutical companies.[2]

The Central Role of FcRn in IgG Homeostasis

To understand the therapeutic action of Nipocalimab, it is essential to first understand its target: the neonatal Fc receptor (FcRn). Encoded by the FCGRT gene, FcRn is a protein structurally similar to major histocompatibility complex (MHC) class I molecules.[9] Its primary and most well-understood function is to act as the master regulator of IgG and albumin concentrations in the body.[11]

The mechanism of this regulation is a sophisticated cellular recycling process. IgG and albumin are non-selectively taken into cells from the bloodstream through a process called pinocytosis. Inside the resulting intracellular vesicles, known as endosomes, the environment becomes acidic (pH ~6.0). At this acidic pH, FcRn binds to the Fc region of IgG and to albumin. This binding acts as a rescue signal, protecting these proteins from being targeted for degradation in the cell's lysosomal pathway. The FcRn-IgG/albumin complex is then recycled back to the cell surface. Upon exposure to the neutral pH of the bloodstream (pH ~7.4), the binding affinity is lost, and the IgG and albumin are released back into circulation, intact.[14] This continuous salvage pathway is responsible for the remarkably long half-life of IgG (approximately 21 days) compared to other immunoglobulin isotypes, which are not rescued by FcRn and are rapidly degraded.[11]

In addition to this homeostatic role, FcRn has two other key physiological functions. It is responsible for the active transport of maternal IgG across the placenta to the fetus, which provides the newborn with crucial passive immunity.[9] It is also involved in enhancing the presentation of antigens by professional antigen-presenting cells, thus playing a role in the adaptive immune response.[10]

Mechanism of Action: High-Affinity, pH-Independent FcRn Blockade

Nipocalimab exerts its therapeutic effect by acting as a high-affinity, competitive antagonist of FcRn.[1] It is designed to bind selectively to the same site on FcRn that endogenous IgG uses. By occupying this binding site, Nipocalimab physically blocks endogenous IgG—including the pathogenic autoantibodies that drive autoimmune diseases and the alloantibodies responsible for maternal-fetal conditions—from being rescued. This disruption of the recycling pathway forces the pathogenic IgG molecules to proceed to the lysosome for catabolism and clearance from the body.[1] The result is a rapid, dose-dependent, and substantial reduction in the total circulating levels of all IgG subclasses, with clinical studies showing reductions of greater than 75%.[1] This is achieved with high selectivity, as Nipocalimab does not affect the production of new IgG antibodies nor the levels of other immunoglobulins such as IgA or IgM.[1]

A crucial and distinguishing feature of Nipocalimab's molecular design is its pH-independent binding to FcRn. Preclinical and structural studies have demonstrated that Nipocalimab binds to FcRn with high affinity at both the acidic pH of the endosome (pH 6.0) and the neutral pH of the extracellular environment (pH 7.6).[1] This is a departure from the natural biology of IgG-FcRn interaction and from the design of some other FcRn antagonists. The ability to bind with high affinity at neutral pH means that Nipocalimab can saturate FcRn not only within the endosome but also at the cell surface. This has profound mechanistic implications, particularly for its use in maternal-fetal diseases. By blocking FcRn on the surface of placental cells, Nipocalimab can inhibit the very first step of maternal IgG uptake, providing a more comprehensive blockade of transplacental antibody transfer than a purely pH-dependent blocker might achieve.[18] This sustained, high-affinity binding across the entire physiological pH gradient likely contributes to a more profound and durable saturation of the FcRn system, providing a pharmacological rationale for the "sustained disease control" that has been a central theme in its clinical trial results and marketing. This differentiated binding profile is therefore not merely a biochemical curiosity but a core feature that enables Johnson & Johnson's unique clinical and strategic approach for the drug.

Characteristic	Detail	Source(s)
Generic Name	Nipocalimab (nipocalimab-aahu)	2
Brand Name	Imaavy™	2
DrugBank ID	DB16257	1
CAS Number	2211985-36-1	2
Type	Biotech, Monoclonal Antibody	1
Molecular Class	Fully human, aglycosylated, effectorless IgG1λ	1
Target	Neonatal Fc Receptor (FCGRT) large subunit p51	1
Mechanism of Action	FcRn Blocker (Antagonist)	1
Developer	Johnson & Johnson (via acquisition of Momenta Pharmaceuticals)	2
Route of Administration	Intravenous Infusion	2
Table 1: Nipocalimab - Key Drug Characteristics

Clinical Development in Generalized Myasthenia Gravis (gMG)

The clinical program for Nipocalimab in generalized myasthenia gravis (gMG) culminated in its first regulatory approval and established the foundation for its market entry. The program was designed to demonstrate efficacy and safety in a broad patient population, including adolescents, setting it apart from its competitors at launch.

Pivotal Phase 3 Vivacity-MG3 Study (NCT04951622)

The Vivacity-MG3 trial was the cornerstone of the gMG development program. It was a global, multicenter, randomized (1:1), double-blind, placebo-controlled study designed to rigorously evaluate the efficacy and safety of Nipocalimab in adults with gMG.[22]

Study Design and Patient Population

The trial enrolled 199 patients with moderate to severe gMG (Myasthenia Gravis Foundation of America [MGFA] Class II-IV) who had an inadequate response to their current standard-of-care (SOC) therapies, defined by a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 6.[22] A key strategic element of the trial's design was its broad inclusion criteria. It enrolled patients who were positive for autoantibodies against the acetylcholine receptor (AChR), muscle-specific tyrosine kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4), as well as patients who were triple-autoantibody-negative.[25] This approach was intended to assess Nipocalimab's utility across the widest possible spectrum of gMG patients.

Participants were randomized to receive either Nipocalimab (a 30 mg/kg loading dose followed by 15 mg/kg every two weeks) or a matching placebo, both administered as intravenous infusions in addition to their ongoing SOC therapy.[22] The double-blind treatment phase lasted 24 weeks, after which eligible patients could enter an ongoing open-label extension (OLE) phase to assess long-term outcomes.[22]

Efficacy Results

The Vivacity-MG3 trial successfully met its primary and key secondary endpoints, demonstrating both statistically significant and clinically meaningful benefits for patients treated with Nipocalimab.

• Primary Endpoint (MG-ADL Score): The trial achieved its primary endpoint, which was the change from baseline in the MG-ADL total score, averaged over weeks 22, 23, and 24. Patients in the Nipocalimab group experienced a least-squares mean change of -4.70 points, compared to -3.25 points in the placebo group. This resulted in a statistically significant difference of -1.45 points (95% CI: -2.38 to -0.52; p=0.0024).[22] This magnitude of improvement is considered highly clinically relevant, as a change of just 1 to 2 points on the MG-ADL scale can represent the difference between normal swallowing and frequent choking, or between normal breathing and shortness of breath at rest.[29]
• Secondary Endpoint (QMG Score): Nipocalimab also demonstrated significant superiority on the key secondary endpoint, the Quantitative Myasthenia Gravis (QMG) score, a clinician-assessed measure of muscle strength. The mean change from baseline in the QMG score was -4.86 for Nipocalimab versus -2.05 for placebo, yielding a treatment difference of -2.81 (p<0.001).[29]

Long-Term Sustained Disease Control

Data from the ongoing OLE phase of the study have been crucial for building the narrative of sustained disease control. These results show that the clinical benefits observed in the 24-week double-blind phase are maintained and even deepen over time. At 48 weeks into the OLE (72 weeks from original baseline), the mean change in MG-ADL score from the original study baseline was -5.97 for patients who had been on Nipocalimab continuously.[26] Importantly, patients who transitioned from placebo to Nipocalimab in the OLE experienced a similar profound improvement, with a mean change in MG-ADL of -6.01, reinforcing the drug's efficacy.[31] These long-term data, extending out to 84 weeks, support the positioning of Nipocalimab as a therapy that provides durable, long-lasting symptom control.[24]

Safety and Tolerability Profile

The safety profile of Nipocalimab in Vivacity-MG3 was found to be manageable and consistent with previous studies. The overall incidence of adverse events (AEs) was similar between the Nipocalimab and placebo groups, with 84% of patients in each arm reporting at least one AE.[22] The most common AEs were infections (43% in both groups) and headache (14% in the Nipocalimab group vs. 17% in the placebo group).[22] The rate of serious AEs was numerically lower in the Nipocalimab arm (9%) compared to the placebo arm (14%). There was one death in the Nipocalimab group due to a myasthenic crisis, and two deaths in the placebo group (one from cardiac arrest and one from myocardial infarction).[22]

VIBRANCE-MG (NCT05265273): Establishing Efficacy in an Adolescent Population

To secure the broadest possible label, Johnson & Johnson conducted the VIBRANCE-MG study, a Phase 2/3 trial specifically in adolescents (aged 12-17) with gMG.[32] This study was critical for providing direct evidence of efficacy and safety in a younger population, rather than relying on extrapolation from adult data. The trial met its primary endpoint, showing a 69% reduction in total serum IgG over 24 weeks, confirming the drug's pharmacological activity in adolescents. Furthermore, it met secondary endpoints, demonstrating clinical improvements on the MG-ADL and QMG scales, which ultimately provided the basis for its pediatric approval.[32]

FDA Approval and Prescribing Information for Imaavy™

On the strength of the comprehensive data package from the Vivacity-MG3 and VIBRANCE-MG trials, the FDA granted approval for Imaavy™ (nipocalimab-aahu) on April 30, 2025, following a Priority Review of the Biologics License Application (BLA).[8]

• Approved Indication: Imaavy™ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-AChR or anti-MuSK antibody positive.[1] This indication was the broadest among all FcRn blockers at the time of its approval.
• Dosage and Administration: The approved regimen consists of an initial 30 mg/kg loading dose administered via intravenous infusion, followed by maintenance doses of 15 mg/kg every two weeks.[21]
• Warnings and Precautions: The prescribing information highlights the risk of infections as a common and potentially serious side effect, a known class effect for therapies that lower IgG levels. It also includes warnings for potential hypersensitivity and infusion-related reactions.[20]
• Commercial Support: To facilitate patient access, Johnson & Johnson launched a patient support program in the U.S. called "IMAAVY withMe".[20]

Endpoint	Nipocalimab + SOC	Placebo + SOC	LS Mean Difference (95% CI)	p-value
MG-ADL Score (Change from Baseline over Wks 22-24)	-4.70	-3.25	-1.45 (-2.38 to -0.52)	0.0024
QMG Score (Change from Baseline over Wks 22-24)	-4.86	-2.05	-2.81	<0.001
MG-ADL Response (≥2-point improvement over Wks 22-24)	Significantly greater	---	---	0.021
Table 2: Efficacy Outcomes of the Phase 3 Vivacity-MG3 Trial (Antibody-Positive Population) 22

Expansion into Maternal-Fetal and Rare Autoantibody Diseases

A cornerstone of Johnson & Johnson's strategy for Nipocalimab is its development in indications where its unique pharmacological properties offer a distinct advantage. The company has made a significant investment in pursuing maternal-fetal diseases, an area with profound unmet need and no approved targeted therapies. This strategic choice is not arbitrary; it is directly enabled by Nipocalimab's mechanism of action. By blocking the FcRn-mediated transport of pathogenic maternal alloantibodies across the placenta, Nipocalimab has the potential to prevent disease in the fetus in utero.[6] This positions the drug in a therapeutic space largely uncontested by its competitors and establishes a powerful, differentiated value proposition. The FDA's recognition of this potential, through multiple special designations, has validated this approach and accelerated the development pathway.

Hemolytic Disease of the Fetus and Newborn (HDFN)

HDFN is a rare and potentially devastating condition that occurs when a pregnant individual's immune system produces alloantibodies (e.g., anti-RhD, anti-Kell) against the red blood cells of the fetus. These maternal IgG antibodies cross the placenta and cause hemolysis, leading to severe fetal anemia, a life-threatening condition known as hydrops fetalis, or neonatal death.[6]

The proof-of-concept for Nipocalimab in this indication came from the Phase 2 UNITY study (NCT03842189). The results from this trial were highly compelling and formed the basis for the FDA's Breakthrough Therapy Designation. The study met its primary endpoint, with 54% of participants treated with Nipocalimab achieving a live birth at or after 32 weeks of gestation without requiring an invasive intrauterine transfusion (IUT). This outcome was a dramatic improvement over a historical benchmark of 0-10% for this high-risk population.[6] The landmark findings were subsequently published in

The New England Journal of Medicine, underscoring their significance.[6]

Building on this success, Johnson & Johnson has initiated the pivotal Phase 3 AZALEA study (NCT05912517). This randomized, placebo-controlled trial is currently enrolling pregnant individuals with a history of severe HDFN and is designed to confirm the efficacy and safety of Nipocalimab in preventing severe fetal anemia.[2] The primary completion of this crucial study is estimated for August 2027.[42]

Warm Autoimmune Hemolytic Anemia (wAIHA)

Nipocalimab is also being investigated for wAIHA, an autoimmune disorder characterized by IgG autoantibodies that bind to and cause the premature destruction of red blood cells at normal body temperature, leading to anemia.[44] Currently, there are no FDA-approved targeted therapies for wAIHA, representing a significant unmet medical need.[44]

The ongoing Phase 2/3 ENERGY study (NCT04119050), which was the subject of the initial user query, is a randomized, double-blind, placebo-controlled trial evaluating Nipocalimab as an add-on therapy to SOC.[44] The study is expected to read out in 2025, with primary completion estimated for March of that year.[45] The establishment of a post-trial access program (NCT05221619) for patients who have completed the ENERGY open-label extension and are experiencing clinical benefit suggests that positive signals have been observed in the main trial, providing optimism for the program's success.[47]

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

In addition to HDFN, Nipocalimab is being developed for FNAIT, another serious alloimmune disease of pregnancy where maternal antibodies attack and destroy fetal platelets. The program is advancing with a pivotal Phase 3 trial named FREESIA.[2] The FDA has granted both Fast Track and Orphan Drug designations for Nipocalimab in FNAIT, recognizing the high unmet need and the drug's potential to address it.[46]

Investigational Programs in Prevalent Rheumatologic Conditions

Johnson & Johnson's development strategy for Nipocalimab in prevalent rheumatologic diseases showcases an adaptive and data-driven approach. By pursuing indications like Sjögren's disease and rheumatoid arthritis, the company aims to expand the drug's reach into larger patient populations. The divergent outcomes of the initial studies in these two diseases have led to a nuanced strategy: accelerating development where the monotherapy mechanism of action proved highly effective, while pivoting to a combination approach where a synergistic effect is required.

Sjögren's Disease (SjD)

Sjögren's disease is a chronic, systemic autoimmune disease characterized by inflammation of exocrine glands and the production of autoantibodies, primarily anti-Ro and anti-La. There is a significant unmet need for therapies that treat the underlying systemic nature of the disease.[49]

The Phase 2 DAHLIAS study (NCT04968912) was a dose-ranging trial that yielded unequivocally positive results. The study met its primary endpoint, with the 15 mg/kg dose of Nipocalimab demonstrating a statistically significant and clinically meaningful improvement in the Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) score at Week 24 compared to placebo (p=0.002).[50] This response was observed as early as Week 4 and continued to increase throughout the treatment period.[52]

Positive trends were also observed across multiple secondary endpoints, including physician assessments of disease activity and patient-reported symptoms like mouth and eye dryness.[51] Pharmacodynamically, the study confirmed the drug's mechanism, showing significant reductions in total IgG and the key autoantibodies associated with SjD.[52]

The strength of these results led the FDA to grant Nipocalimab both Breakthrough Therapy Designation (November 2024) and Fast Track Designation (March 2025) for SjD, highlighting its potential to be a first-in-class systemic therapy.[49] Based on this success, Johnson & Johnson has initiated the global Phase 3 DAFFODIL program (NCT06741969), which consists of two identical pivotal studies designed to confirm the efficacy and safety of Nipocalimab in this patient population.[55]

Rheumatoid Arthritis (RA)

In contrast to the success in Sjögren's disease, the initial approach in rheumatoid arthritis yielded different results. The Phase 2a IRIS-RA study (NCT04991753) evaluated Nipocalimab as a monotherapy in patients with moderate-to-severe active RA who were refractory to anti-TNF agents. The study did not meet its primary endpoint of achieving a statistically significant change in the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) at Week 12.[58]

Despite failing to meet the primary clinical endpoint, the study was considered a successful proof-of-mechanism. Nipocalimab treatment led to consistent numerical improvements across a range of efficacy endpoints and, critically, demonstrated significant reductions in the levels of total IgG, anti-citrullinated protein antibodies (ACPA), and circulating immune complexes.[58] The clinical benefit was also observed to be more pronounced in the subgroup of patients who had higher levels of ACPA at baseline, suggesting that the drug was most effective in patients whose disease was more strongly driven by autoantibodies.[58]

This outcome demonstrated that while lowering pathogenic IgG levels is a necessary component of treating RA, it may not be sufficient as a monotherapy in a disease with multiple, complex inflammatory pathways. In response, Johnson & Johnson adapted its strategy. Rather than abandoning the indication, the company initiated the Phase 2a DAISY-RA study (NCT06028438). This trial is designed to investigate Nipocalimab in combination with an anti-TNFα therapy, exploring the hypothesis that the complementary mechanisms of action—one targeting autoantibodies and the other targeting a key inflammatory cytokine—will produce a synergistic clinical benefit in this difficult-to-treat patient population.[60]

Competitive Landscape and Strategic Analysis

Nipocalimab (Imaavy™) is entering a dynamic and increasingly competitive therapeutic class. Its success will depend not only on its clinical profile but also on Johnson & Johnson's ability to strategically differentiate it from other approved and pipeline FcRn inhibitors.

The FcRn Blocker Class: A Comparative Overview

The primary competitors for Nipocalimab in the gMG market are efgartigimod (marketed as Vyvgart® and Vyvgart® Hytrulo by Argenx) and rozanolixizumab (marketed as Rystiggo® by UCB).[32] All three therapies are based on the same fundamental mechanism of blocking the FcRn receptor to accelerate the degradation of pathogenic IgG antibodies.[65]

However, there are key differences that will influence physician and patient choice:

• Molecular Structure: Nipocalimab is a full-length human monoclonal antibody, whereas efgartigimod is an engineered human IgG1 Fc fragment.[1]
• Route of Administration: At launch, Nipocalimab is an intravenous (IV) infusion. Efgartigimod is available in both IV and subcutaneous (SC) formulations, while rozanolixizumab is an SC infusion.[32]
• Dosing Regimen: Nipocalimab is administered as a consistent bi-weekly maintenance infusion. In contrast, efgartigimod is approved for administration in treatment cycles, which may be initiated based on clinical evaluation, a paradigm that can be viewed as either flexible or less predictable.[36]

Indirect Treatment Comparisons (ITCs) and Competitive Positioning

In the absence of direct head-to-head clinical trials, which are rarely conducted for commercial reasons, pharmaceutical companies often rely on indirect treatment comparisons (ITCs) to build a competitive narrative. Johnson & Johnson has proactively conducted and published ITCs comparing the efficacy of Nipocalimab with the publicly available Phase 3 data from its competitors in gMG.[70]

While these analyses have inherent limitations, they are a key component of the commercial strategy. The results of these ITCs consistently suggest that Nipocalimab provides a comparable onset of action and achieves "greater or statistically significant improvement" in MG-ADL scores at multiple timepoints over 24 weeks when compared to the other approved FcRn blockers.[71]

This data is being strategically deployed to support a specific value proposition for Imaavy™: sustained disease control with a predictable, non-cyclic dosing schedule. This positioning directly contrasts with the cyclical treatment paradigm of efgartigimod, aiming to appeal to physicians and patients who may prefer a more consistent and plannable treatment approach to manage a chronically unpredictable disease like gMG.[70]

Strategic Implications and Future Outlook

Nipocalimab's overall strategic position is strong, underpinned by several key factors:

• Broadest Label at Launch: A significant initial advantage for Imaavy™ is its FDA approval for both anti-AChR and anti-MuSK positive gMG in both adults and adolescents (12 years and older). This is a broader patient population than its competitors had at their respective launches, potentially allowing for greater initial market penetration.[20]
• The "Pipeline-in-a-Product" Strategy: The true long-term value of Nipocalimab lies in its potential across numerous indications. With an approved therapy in gMG, a Breakthrough Therapy Designation in SjD, a validated and highly promising program in HDFN, and ongoing trials in wAIHA, RA, and FNAIT, Nipocalimab has the potential to become a multi-billion dollar "pipeline-in-a-product" for Johnson & Johnson.[2]
• Future Catalysts: The trajectory of the Nipocalimab franchise will be heavily influenced by upcoming clinical trial readouts. Key catalysts to monitor include the results from the Phase 2/3 ENERGY trial in wAIHA (expected in 2025), the pivotal Phase 3 AZALEA trial in HDFN, and the Phase 3 DAFFODIL program in SjD. Positive outcomes in these trials are essential for realizing the full blockbuster potential of the asset.

Feature	Nipocalimab (Imaavy™)	Efgartigimod (Vyvgart®/Vyvgart® Hytrulo)	Rozanolixizumab (Rystiggo®)
Company	Johnson & Johnson	Argenx	UCB
Approved gMG Population	AChR+, MuSK+; Adults & Adolescents (≥12 yrs)	AChR+; Adults (IV/SC)	AChR+, MuSK+; Adults
Route of Administration	Intravenous (IV)	IV and Subcutaneous (SC)	Subcutaneous (SC)
Dosing Schedule	Bi-weekly maintenance	Cyclical (IV/SC)	Weekly
Key Differentiator	Sustained disease control, broadest label at launch	First-in-class, flexible cyclical dosing, SC option	SC option for AChR+ and MuSK+
Table 3: Comparative Profile of Approved FcRn Inhibitors for gMG 20

Indication	FDA Breakthrough Therapy	FDA Fast Track	FDA Orphan Drug	FDA Priority Review	EMA Orphan Designation
Generalized Myasthenia Gravis (gMG)	No	Yes (Dec 2021)	Yes (Feb 2021)	Yes (Q4 2024)	No
Hemolytic Disease of the Fetus and Newborn (HDFN)	Yes (Feb 2024)	Yes (Jul 2019)	Yes (Jun 2020)	No	Yes (Oct 2019)
Warm Autoimmune Hemolytic Anemia (wAIHA)	No	Yes (Jul 2019)	Yes (Dec 2019)	No	No
Sjögren's Disease (SjD)	Yes (Nov 2024)	Yes (Mar 2025)	No	No	No
Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT)	No	Yes (Mar 2024)	Yes (Dec 2023)	No	No
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	No	No	Yes (Oct 2021)	No	No
Table 4: Summary of Nipocalimab's Regulatory Designations by Indication 2

Conclusion

Nipocalimab (Imaavy™) has emerged as a formidable new entrant in the field of immunotherapeutics. Its approval for generalized myasthenia gravis with the broadest label in its class is a testament to a well-executed clinical program and a differentiated molecular profile. The drug's high-affinity, pH-independent binding to the neonatal Fc receptor (FcRn) provides a strong pharmacological basis for its demonstrated efficacy and supports a compelling narrative of sustained disease control.

The strategic vision for Nipocalimab extends far beyond gMG. Johnson & Johnson is pursuing a "pipeline-in-a-product" strategy that is both ambitious and logical. The focus on maternal-fetal diseases like HDFN and FNAIT is a masterstroke of differentiation, leveraging a unique aspect of the drug's mechanism to address a profound unmet need in a space with no competition. Success in this area would not only provide a life-altering therapy for affected families but also create a durable and defensible market position for the franchise.

Furthermore, the expansion into prevalent rheumatologic conditions like Sjögren's disease, where Nipocalimab has already achieved Breakthrough Therapy Designation, opens up significant commercial opportunities. The company's adaptive strategy in rheumatoid arthritis—pivoting from a failed monotherapy trial to a rational combination study—demonstrates scientific rigor and a commitment to maximizing the asset's potential across different disease contexts.

While the competitive landscape for FcRn inhibitors is intensifying, Nipocalimab is well-positioned to compete effectively through its broad label, predictable dosing regimen, and unique profile in pregnancy-related alloimmune disorders. The future of the franchise will be shaped by the outcomes of its ongoing pivotal trials in wAIHA, HDFN, and SjD. Continued success in these programs will be critical to solidifying Imaavy™ as a cornerstone therapy for a wide spectrum of IgG-mediated diseases and realizing its full potential as a multi-billion dollar asset for Johnson & Johnson.

Works cited

1. Nipocalimab: Uses, Interactions, Mechanism of Action | DrugBank Online, accessed June 24, 2025, https://go.drugbank.com/drugs/DB16257
2. Nipocalimab - Wikipedia, accessed June 24, 2025, https://en.wikipedia.org/wiki/Nipocalimab
3. Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Neonatal Fc Receptor Blocker, in Healthy Japanese Volunteers - PMC, accessed June 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11339140/
4. Nipocalimab | M281 | anti-FcRn monoclonal antibody - TargetMol, accessed June 24, 2025, https://www.targetmol.com/compound/nipocalimab
5. Nipocalimab (Anti-FcRn) (FCGRT & B2M) | Read Reviews & Product Use Citations, accessed June 24, 2025, https://www.selleckchem.com/products/nipocalimab-anti-fcrn-fcgrt--b2m.html
6. Nipocalimab Shows Significant Promise Treating Early-Onset Severe Hemolytic Disease of the Fetus and Newborn - Applied Clinical Trials, accessed June 24, 2025, https://www.appliedclinicaltrialsonline.com/view/nipocalimab-early-onset-severe-hemolytic-disease-fetus-newborn
7. Nipocalimab - Johnson & Johnson - AdisInsight - Springer, accessed June 24, 2025, https://adisinsight.springer.com/drugs/800045634
8. Nipocalimab: What is it and is it FDA approved? - Drugs.com, accessed June 24, 2025, https://www.drugs.com/history/nipocalimab.html
9. pmc.ncbi.nlm.nih.gov, accessed June 24, 2025, [https://pmc.ncbi.nlm.nih.gov/articles/PMC2970823/#:~:text=The%20neonatal%20Fc%20receptor%20(FcRn,by%20professional%20antigen%20presenting%20cells.](https://www.google.com/url?q=https://pmc.ncbi.nlm.nih.gov/articles/PMC2970823/%23:~:text%3DThe%2520neonatal%2520Fc%2520receptor%2520(FcRn,by%2520professional%2520antigen%2520presenting%2520cells.&sa=D&source=editors&ust=1750753252185805&usg=AOvVaw2dX4LYfAuqmzupynn9uHfd)
10. The Neonatal Fc Receptor (FcRn): A Misnomer? - Frontiers, accessed June 24, 2025, https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2019.01540/full
11. The Neonatal Fc Receptor: Key to Homeostasic Control of IgG and IgG-Related Biopharmaceuticals - PMC, accessed June 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC6591018/
12. Neonatal Fc Receptor: From Immunity to Therapeutics - PMC - PubMed Central, accessed June 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC2970823/
13. The neonatal Fc receptor expression during macrophage differentiation is related to autophagy - Frontiers, accessed June 24, 2025, https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.1054425/full
14. The Role of FcRn in Immunology and Therapeutics - RoukenBio, accessed June 24, 2025, https://rouken.bio/scientific-resources/insights/the-role-of-fc-rn-in-immunology-and-therapeutics
15. Proposed Mechanism of Action - Efgartigimod - argenx, accessed June 24, 2025, https://argenx.com/pipeline/efgartigimod/mechanism-of-action-efgartigimod
16. Full article: Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties, accessed June 24, 2025, https://www.tandfonline.com/doi/full/10.1080/19420862.2025.2461191
17. What is Nipocalimab used for? - Patsnap Synapse, accessed June 24, 2025, https://synapse.patsnap.com/article/what-is-nipocalimab-used-for
18. New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases, accessed June 24, 2025, https://innovativemedicine.jnj.com/us/new-nipocalimab-data-published-in-mabs-journal-details-differentiated-molecular-design-clinical-profile-and-potential-of-nipocalimab-to-treat-igg-driven-alloantibody-and-autoantibody-diseases
19. How Nipocalimab Targets Unmet Needs in Autoimmune Care, accessed June 24, 2025, https://www.ajmc.com/view/how-nipocalimab-targets-unmet-needs-in-autoimmune-care
20. Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) - BioSpace, accessed June 24, 2025, https://www.biospace.com/press-releases/johnson-johnson-receives-fda-approval-for-imaavy-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg
21. IMAAVYTM (nipocalimab-aahu) injection, for intravenous use - accessdata.fda.gov, accessed June 24, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761430s000lbl.pdf
22. Safety and efficacy of nipocalimab in adults with generalised ..., accessed June 24, 2025, https://pubmed.ncbi.nlm.nih.gov/39862879/
23. A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis, accessed June 24, 2025, https://clinicaltrials.gov/study/NCT04951622?term=AREA%5BBasicSearch%5D(nipocalimab)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20ACTIVE_NOT_RECRUITING)&rank=6
24. Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG), accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/johnson-johnson-highlights-new-data-that-showcase-the-strength-of-nipocalimab-demonstrating-long-term-sustained-disease-control-in-adults-living-with-generalized-myasthenia-gravis-gmg
25. New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG) - PR Newswire, accessed June 24, 2025, https://www.prnewswire.com/news-releases/new-nipocalimab-data-and-real-world-research-at-aan-2025-highlight-positive-phase-3-results-and-commitment-to-people-living-with-generalized-myasthenia-gravis-gmg-302411409.html
26. Long-term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-label Extension Phase Results (P7-11.022) - Neurology.org, accessed June 24, 2025, https://www.neurology.org/doi/10.1212/WNL.0000000000211115
27. FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis, accessed June 24, 2025, https://www.appliedclinicaltrialsonline.com/view/fda-approves-nipocalimab--treatment-generalized-myasthenia-gravis
28. Vivacity-MG3 Trial Confirms Nipocalimab's Efficacy, Safety in Treating Generalized Myasthenia Gravis, accessed June 24, 2025, https://www.appliedclinicaltrialsonline.com/view/vivacity-trial-nipocalimab-generalized-myasthenia-gravis
29. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class, accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class
30. Positive phase III results for nipocalimab in generalised myasthenia gravis, accessed June 24, 2025, https://www.institut-myologie.org/en/2025/03/04/positive-phase-iii-results-for-nipocalimab-in-generalised-myasthenia-gravis/
31. Efficacy of Nipocalimab To Treat Myasthenia Gravis: Updates From Vivacity-MG3 Trial, accessed June 24, 2025, https://checkrare.com/efficacy-of-nipcalimab-to-treat-myasthenia-gravis-updates-from-vivacity-mg3-trial/
32. FDA Approves FcRn Blocker Nipocalimab for Broad Forms of Generalized Myasthenia Gravis - NeurologyLive, accessed June 24, 2025, https://www.neurologylive.com/view/fda-approves-fcrn-blocker-nipocalimab-broad-forms-generalized-myasthenia-gravis
33. Johnson & Johnson receives FDA approval for IMAAVYTM ..., accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg
34. CENTER FOR DRUG EVALUATION AND RESEARCH - accessdata.fda.gov, accessed June 24, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761430Orig1s000Approv.pdf
35. Imaavy (nipocalimab) dosing, indications, interactions, adverse effects, and more, accessed June 24, 2025, https://reference.medscape.com/drug/imaavy-nipocalimab-4000490
36. Dosing & Administration | IMAAVY™ (nipocalimab-aahu), accessed June 24, 2025, https://www.imaavyhcp.com/generalized-myasthenia-gravis/dosing-and-administration/
37. Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) - PR Newswire, accessed June 24, 2025, https://www.prnewswire.com/news-releases/johnson--johnson-receives-fda-approval-for-imaavy-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg-302442650.html
38. Johnson's nipocalimab granted U.S. FDA Breakthrough ... - Johnson, accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/johnson-johnsons-nipocalimab-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-individuals-at-high-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn
39. J&J publishes nipocalimab Phase II HDFN data as Phase III continues enrolment, accessed June 24, 2025, https://www.clinicaltrialsarena.com/news/jj-publishes-nipocalimab-phase-ii-hdfn-data-as-phase-iii-continues-enrolment/
40. New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN), accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/new-phase-2-data-demonstrate-potential-benefit-of-nipocalimab-for-pregnant-individuals-at-high-risk-of-early-onset-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn
41. Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn - PubMed, accessed June 24, 2025, https://pubmed.ncbi.nlm.nih.gov/39115062/
42. A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) | ClinicalTrials.gov, accessed June 24, 2025, https://clinicaltrials.gov/study/NCT05912517?term=AREA%5BBasicSearch%5D(nipocalimab)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20ACTIVE_NOT_RECRUITING)&rank=7
43. Study Details | Study of 19(T2)28z1xx TRAC-Chimeric Antigen ..., accessed June 24, 2025, https://clinicaltrials.gov/study/NCT05912517
44. Nipocalimab - Overview of the Phase 2/3 ENERGY Clinical Trial, accessed June 24, 2025, https://www.jnjmedicalconnect.com/products/nipocalimab/medical-content/nipocalimab-overview-of-the-phase-23-energy-clinical-trial
45. Nipocalimab (M281) to treat warm autoimmune hemolytic anemia - PCORI® Horizon Scanning Database, accessed June 24, 2025, https://horizonscan.ecri.org/report/topics/518
46. Warm autoimmune hemolytic anemia (wAIHA) research presented by Johnson & Johnson highlights profound disease burden and unmet need for targeted treatment options - PR Newswire, accessed June 24, 2025, https://www.prnewswire.com/news-releases/warm-autoimmune-hemolytic-anemia-waiha-research-presented-by-johnson--johnson-highlights-profound-disease-burden-and-unmet-need-for-targeted-treatment-options-302326112.html
47. Study Details | Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | ClinicalTrials.gov, accessed June 24, 2025, https://www.clinicaltrials.gov/study/NCT05221619
48. Nipocalimab: A Promising New Treatment for Various Autoimmune Disorders - Clinical trials, accessed June 24, 2025, https://clinicaltrials.eu/inn/nipocalimab/
49. Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation - PR Newswire, accessed June 24, 2025, https://www.prnewswire.com/news-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation-302404447.html
50. Nipocalimab, the first and only investigational treatment to be ..., accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation
51. Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren's disease study, accessed June 24, 2025, https://innovativemedicine.jnj.com/emea/nipocalimab-demonstrates-significant-clinical-improvement-in-disease-activity-and-igg-reduction-in-phase-2-sjogrens-disease-study
52. Late-breaking results show nipocalimab significantly improves ..., accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/late-breaking-results-show-nipocalimab-significantly-improves-sjogrens-disease-activity-in-a-phase-2-study
53. Johnson & Johnson's nipocalimab shows promise in Sjögren's disease trial, accessed June 24, 2025, https://www.clinicaltrialsarena.com/news/johnson-johnson-nipocalimab-trial/
54. Pharmacodynamic Effects of Nipocalimab on Disease Biomarkers in Patients with Moderate-to-Severe Active Sjögren's Disease: Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2 Study - ACR Meeting Abstracts, accessed June 24, 2025, https://acrabstracts.org/abstract/pharmacodynamic-effects-of-nipocalimab-on-disease-biomarkers-in-patients-with-moderate-to-severe-active-sjogrens-disease-results-from-a-multicenter-randomized-double-blinded-placebo-controlled-p/
55. Sjögren's Syndrome Recruiting Phase 3 Trials for Nipocalimab (DB16257) - DrugBank, accessed June 24, 2025, https://go.drugbank.com/indications/DBCOND0043409/clinical_trials/DB16257?phase=3&status=recruiting
56. Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL) | Global Trial Finder, accessed June 24, 2025, https://globaltrialfinder.janssen.com/trial/80202135sjs3001
57. Study Details | Nipocalimab in Moderate to Severe Sjogren's Disease | ClinicalTrials.gov, accessed June 24, 2025, https://clinicaltrials.gov/study/NCT06741969
58. Nipocalimab, an anti-FcRn monoclonal antibody, in participants with ..., accessed June 24, 2025, https://rmdopen.bmj.com/content/10/2/e004278
59. Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study - PubMed, accessed June 24, 2025, https://pubmed.ncbi.nlm.nih.gov/38942592/
60. Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study, accessed June 24, 2025, https://innovativemedicine.jnj.com/phase-2-nipocalimab-data-establish-proof-mechanism-adults-living-moderate-severe-rheumatoid
61. Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study, accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/phase-2-nipocalimab-data-establish-proof-of-mechanism-in-adults-living-with-moderate-to-severe-rheumatoid-arthritis-supporting-its-progression-into-a-combination-study
62. The efficacy and safety of FcRn inhibitors in patients with myasthenia gravis: a systematic review and meta-analysis - PubMed, accessed June 24, 2025, https://pubmed.ncbi.nlm.nih.gov/38431900/
63. J&J looks to challenge argenx's Vyvgart with positive Phase III data - Clinical Trials Arena, accessed June 24, 2025, https://www.clinicaltrialsarena.com/news/jj-looks-to-challenge-argenxs-vyvgart-with-positive-phase-iii-data/
64. FDA Approves Nipocalimab for Generalized Myasthenia Gravis, accessed June 24, 2025, https://www.ajmc.com/view/fda-approves-nipocalimab-for-generalized-myasthenia-gravis
65. What is the mechanism of Efgartigimod? - Patsnap Synapse, accessed June 24, 2025, https://synapse.patsnap.com/article/what-is-the-mechanism-of-efgartigimod
66. Efgartigimod: First Approval - PMC, accessed June 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC8855644/
67. What is the mechanism of Rozanolixizumab? - Patsnap Synapse, accessed June 24, 2025, https://synapse.patsnap.com/article/what-is-the-mechanism-of-rozanolixizumab
68. Rozanolixizumab for Myasthenia Gravis: a breakthrough treatment and future prospects - PMC - PubMed Central, accessed June 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12045563/
69. Emerging Drugs for Generalized Myasthenia Gravis, accessed June 24, 2025, https://www.cda-amc.ca/sites/default/files/hs-eh/EH0099%20Drugs%20for%20myasthenia%20gravis%20Final.pdf
70. IMAAVYTM (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC), accessed June 24, 2025, https://www.jnj.com/media-center/press-releases/imaavytm-nipocalimab-aahu-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalized-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc
71. Nipocalimab showed greater sustained disease control versus approved FcRn blockers for generalised myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) - GlobeNewswire, accessed June 24, 2025, https://www.globenewswire.com/news-release/2025/06/23/3103291/0/en/Nipocalimab-showed-greater-sustained-disease-control-versus-approved-FcRn-blockers-for-generalised-myasthenia-gravis-gMG-at-multiple-timepoints-over-24-weeks-in-newly-published-ind.html
72. Nipocalimab showed greater sustained disease control versus approved FcRn blockers for generalised myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) - BioSpace, accessed June 24, 2025, https://www.biospace.com/press-releases/nipocalimab-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalised-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc
73. J&J positions nipocalimab to rival Vyvgart after hitting mark in myasthenia gravis trial, accessed June 24, 2025, https://firstwordpharma.com/story/5871382
74. Rozanolixizumab: Uses, Interactions, Mechanism of Action | DrugBank Online, accessed June 24, 2025, https://go.drugbank.com/drugs/DB14919
75. Phase II DAHLIAS Trial Results Lead to Fast Track Designation for Nipocalimab for Sjögren's Disease, accessed June 24, 2025, https://www.appliedclinicaltrialsonline.com/view/dahlias-trial-fast-track-designation-nipocalimab-sjogren-disease