Nipocalimab-aahu

New two-year findings from the Phase 2/3 long-term extension demonstrate sustained disease control through two years, improvement in daily function and muscle strength, and reductions in corticosteroid use in anti-AChR+a adolescents Retrospective survey in adults identified fluctuating symptom control as a top driver for discontinuing prior advanced treatment, with most patient outcomes improving after transitioning to IMAAVY Data among 15 novel abstracts on IMAAVY to be presented at the MGFA Scientific Session during AANEM 2026 SPRING HOUSE, Pa., Sept. 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new findings on IMAAVY® (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) across 15 novel abstracts to be presented at the 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use.1 In addition, a retrospective survey of healthcare professionals (HCPs) treating adults with anti-AChRa or anti-MuSKb antibody-positive gMG provides insight into how fluctuating symptoms and the resulting unmet need for more sustained disease control can drive transitions from one advanced therapy to another.2 Long-term data demonstrated sustained disease control in adolescents with gMG Two-year findings from the Vibrance-MG Phase 2/3 long-term extension study showed sustained disease control in adolescents living with anti-AChR+ gMG alongside continued reductions in corticosteroid use. These findings are consistent with improvements observed in adults in the open-label extension of the Phase 3 Vivacity-MG3 study:1 Daily function and muscle strength improvements were sustained through Week 108: Among participants with available data, mean changes from baseline were −2.88 points in MG-ADLc and −8.25 points in QMGd at Week 108 consistent with findings at Week 4, 24 and at all intervening time points through two years. Corticosteroid reductions were observed: Of the six adolescent patients taking corticosteroids at study entry, three reduced their dose while one discontinued after two years on IMAAVY. No new safety signals were identified through up to two years of treatment: The safety profile of IMAAVY in adolescents was similar to that reported in adults. "For adolescents living with generalized myasthenia gravis, unpredictable muscle weakness and symptoms such as eyelid droop and double vision can affect more than physical health; they can disrupt school, friendships and their growing independence," said Jonathan Strober, M.D., Director, Pediatric Neuromuscular Program and Neuromuscular Clinic Sponsored by the MDA.e "The two-year Vibrance-MG results are encouraging and add to our growing body of evidence of IMAAVY in adolescents with continued improvements in daily function, muscle strength and reductions in corticosteroid use observed over time." Need for sustained disease control drives treatment transitions Findings from a retrospective surveyf of HCPs treating adults with anti-AChR+ or anti-MuSK+ gMG highlight how the need for more sustained disease control can shape treatment decisions—from dissatisfaction with fluctuating symptoms on a prior advanced therapy, to seeking improved efficacy and a consistent treatment schedule when initiating IMAAVY:2 Fluctuating symptom control was the most common driver for discontinuing prior therapy: HCPs cited fluctuating symptom control (54.6%) suggesting that a lack of sustained disease control remains an important unmet need shaping treatment decisions. Consistent treatment schedule and hope for improved efficacy were the top drivers for initiating IMAAVY: Among 97 patients who transitioned from prior advanced therapies to IMAAVY, HCPs most frequently cited preference for a consistent treatment schedule (62.9%) and hope for improved efficacy (56.7%) as reasons for initiating IMAAVY. Positive outcomes reported following transition to IMAAVY: HCPs reported that 73.2% of patients were "much improved" or "very much improved," while 76.4% of patients receiving prednisone reduced their dose and 5.5% discontinued use—an important treatment objective for people living with gMG. "People living with generalized myasthenia gravis can experience fluctuating symptoms that make sustained disease control an important treatment goal. The HCP survey findings provide important insight into the factors shaping treatment decisions, with fluctuating symptom control emerging as the leading reason healthcare professionals reported for discontinuing prior therapy," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The broader clinical evidence for IMAAVY across adolescents and adults, including reductions in corticosteroid use, further informs our understanding of the potential for IMAAVY to deliver sustained disease control across a broad population of people living with gMG." IMAAVY is an immunoselective treatment designed to substantially reduce pathogenic immunoglobulin G (IgG), a root cause of gMG, while preserving B-cell function. It is currently the only FcRn blocker approved for pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody-positive gMG by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).3,4 Editor's notes: a. Anti-AChR+ = anti-acetylcholine receptor positive antibody. b. Anti-MuSK+ = anti-muscle specific tyrosine kinase positive antibody. c. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.5 d. QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.6 e. Dr. Jonathan Strober has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. f. The treatment-switch findings are based on a retrospective, 21-item electronic survey of U.S. neurology HCPs. Eligible HCPs had switched at least one adult with gMG from a prior advanced therapy such as IVIG, an anti-CD19 therapy, complement inhibitor or other FcRn inhibitor; respondents reviewed medical records and reported de-identified data from 97 patients. As findings relied on HCP reporting and retrospective medical record review, they may be subject to information and recall bias. The convenience sample of HCPs may also limit generalizability to broader clinical settings and patient populations, while the cross-sectional design does not allow conclusions about long-term trends or causal relationships. About generalized myasthenia gravis (gMG) Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.7,8 The disease impacts an estimated 700,000 people worldwide.9 The disease affects both men and women and occurs across all ages and racial and ethnic groups, but it most frequently starts in young women and older men.10 Roughly 50% of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.10,11,12 Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.12,13,14,15 Among juvenile MG patients, girls are affected more often than boys, with over 65% of pediatric MG cases in the U.S. diagnosed in girls.16,17,18 Initial disease manifestations are usually eye-related, but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG).19,20,21,22,23,24 This is characterized by severe muscle weakness and difficulties in speech and swallowing.20,21,22,23,24 Approximately 100,000 individuals in the U.S. are living with gMG.25 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.26 About the Phase 2/3 Vibrance-MG study The Phase 2/3 Vibrance-MG study (NCT05265273) is an ongoing open-label study to determine the effect of nipocalimab in pediatric participants with gMG.27 Seven participants aged 12-17 years with a diagnosis of gMG as reflected by a Myasthenia Gravis Foundation of America (MGFA) Class of II through IV at screening, and an insufficient clinical response to ongoing, stable SOC therapy, have been enrolled in the trial.28 Participants must have a positive blood test for either anti-AChR or anti-MuSK autoantibodies.28 The study consists of a screening period of up to four weeks, a 24-week open-label active-treatment phase during which participants receive nipocalimab intravenously every two weeks, and a long-term extension phase; a safety follow-up assessment will be conducted at eight weeks after last dose.28 The primary endpoint of the study is the effect of nipocalimab on total serum IgG, safety and tolerability, and pharmacokinetics in pediatric participants with gMG at 24 weeks. Secondary endpoints include change in MG-ADL and QMG scores at 24 weeks.28,29 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 B-cell function based on in vitro and/or in vivo studies.29,30,31 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.4 IMAAVY is also approved for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.4 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.32,33,34,35,36,37,38,39,40,41 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, 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. 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. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you have any of the following infection symptoms: Allergic (hypersensitivity) reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: Infusion-related reactions. Tell your healthcare provider right away if you get any of these symptoms during or within a few days after your IMAAVY infusion: Do not receive IMAAVY if you have a history of a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis. Refer to the Patient Information section of the Prescribing Information for a complete list of ingredients in IMAAVY. Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you: have had an allergic reaction to IMAAVY. have or had any recent infections or symptoms of infection. have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus). have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines. are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn 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. are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY. 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 in people with gMG treated with IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms. The most common side effects in people with wAIHA treated with IMAAVY include: peripheral edema (swelling in your hands, ankles, or feet), diarrhea, and pyrexia (fever). 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 , or call 1-800-FDA-1088 . Please see the full Prescribing Information and Patient Information 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 or at . Follow us at @JNJInnovMed. 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 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 , , 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 Vu T, et al. Two year follow-up results of nipocalimab in adolescents with Generalized myasthenia gravis during active-treatment and Long-term extension phases: vibrance-mg phase 2/3 study. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session. Poster #25. 2 Kutz C, et al. Retrospective Review of Treatment Switches to Nipocalimab in Generalized Myasthenia Gravis: Real-World Healthcare Provider Perspectives. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session. Poster #55. 3 IMAAVY® U.S. Prescribing Information. Available at: . Last accessed: September 2026. 4 European Medicines Agency. IMAAVY® Summary of Product Characteristics. Available at: . Last accessed: September 2026 5 Wolfe GI. Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. 6 Yin, J et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024;31(8):e16322. 7 Bacci, ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335. 8 Wiendl, H et al. Guideline for the management of myasthenic syndromes. Ther Adv Neurol Disord. 2023; 16:17562864231213240. 9 Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. The Lancet Regional Health - Western Pacific. 10 Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024. 11 Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021. 12 J&J. Data on file. 13 Evoli A, et al. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7. 14 Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. 15 Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011; 2011:404101. 16 Haliloglu G, et al. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2. 17 Parr JR, et al. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42. 18 Mansukhani SA, et al. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr; 200:242-249. 19 Law, N et al. The Lived Experience of Myasthenia Gravis: A Patient-Led Analysis. Neurol Ther. 2021;10(2):1103-1125. 20 National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. Available at: Last accessed: September 2026. 21 Bever, CT et al. (1983), Prognosis of ocular myasthenia. Ann Neurol. 1983;14(5):516-9. 22 Kupersmith, MJ et al. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003;60(2):243-8. 23 National Institute of Neurological Disorders and Stroke. Myasthenia gravis fact sheet. Available at: . Last accessed: September 2026. 24 Cleveland Clinic. Myasthenia Gravis: Treatment & Symptoms. Available at: . Last accessed: September 2026. 25 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020. 26 O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. 27 ClinicalTrials.gov. NCT05265273. Available at: . Last accessed: September 2026. 28 Strober J et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024. 29 Seth, N et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):2461191 30 Zhu, LN et al. FcRn inhibitors: a novel option for the treatment of myasthenia gravis. Neural Regen Res. 2023;18(8):1637-1644. 31 Ling, LE et al. M281, an anti‐fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first‐in‐human study. Clinical Pharmacology & Therapeutics. 2018;105(4):1031–1039. 32 ClinicalTrials.gov. Identifier: NCT03842189. Available at: . Last accessed: September 2026. 33 ClinicalTrials.gov Identifier: NCT05327114. Available at: . Last accessed: September 2026. 34 ClinicalTrials.gov Identifier: NCT04119050. Available at: . Last accessed: September 2026. 35 ClinicalTrials.gov Identifier: NCT05379634. Available at: . Last accessed: September 2026. 36 ClinicalTrials.gov Identifier: NCT05912517. Available at: . 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iStock, rudall30 Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about by AbbVie’s Humira and Sanofi and Regeneron’s Dupixent. Aside from cancer—and in recent years, obesity—immunology is one of biopharma’s hottest therapeutic areas, producing some of the biggest franchises in the industry’s history. AbbVie’s Humira, approved for a wide range of immune-mediated conditions, was the world’s top-selling drug for nearly a decade, from 2012 to 2020 . The anti-TNF antibody was only dethroned in 2021 by Pfizer and BioNTech’s COVID-19 vaccine Comirnaty, but Humira remained a commercial juggernaut that year, slipping only to second with $20.7 billion in sales. “AbbVie remains the commercial benchmark,” Stuti Mahajan, consulting manager at DelveInsight told BioSpace in an email interview. Even as Humira drops off after losing key patent protections, Mahajan noted, the pharma has built a robust immunology portfolio with the IL-23 blocker Skyrizi and the JAK inhibitor Rinvoq, both of which were among the industry’s best-selling drugs last year . Then there’s Sanofi and Regeneron’s IL-4Rα blocker Dupixent, another immunology powerhouse approved for a wide array of indications—including asthma, urticaria and atopic dermatitis—that brought in $17.8 billion revenue in 2025 . But Dupixent, too, is nearing the end of its primary revenue years, with key U.S. exclusivity lasting into 2031 . Earnings Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s. March 4, 2026 · 9 min read · Tristan Manalac Read more To take advantage of these openings in the massive immunology and inflammation (I&I) market, many other drugmakers—big and small—are advancing novel and innovative mechanisms for immune-driven diseases. There are the usual Big Pharma suspects, such as Johnson & Johnson, which Mahajan contended has “the most strategically complete portfolio” with IL-23 blockers Tremfya and Icotyde plus the FcRn inhibitor Imaavy and additional programs. Bristol Myers Squibb and Merck are also challengers in the I&I space, Mahajan said. BMS is combining the TYK2-targeting Sotyktu with next-generation cell therapies, while Merck is proposing the TL1A inhibitor tulisokibart for ulcerative colitis and Crohn’s disease. Meanwhile, smaller specialists like Protagonist Therapeutics, argenx and Oruka Therapeutics are also advancing novel assets to address emerging pathologic pathways or improve upon current approaches to well-established disease drivers. Here, BioSpace looks at six of the biggest immunology targets and the companies tackling them. J&J, Argenx, more home in on FcRn Because of how central it is to autoimmune diseases, FcRn has become one of the bigger immunology targets, according to Matt Phipps, group head of biotechnology equity research at William Blair. The protein, a receptor expressed by tissues throughout the body, recycles IgG antibodies and prolongs their lifespan—in turn sustaining the activity of autoreactive antibodies. Several biopharma players have focused their drug development efforts on FcRn, Phipps told BioSpace via email. Not least of these is Johnson & Johnson, which owns Imaavy, a monoclonal antibody approved for generalized myasthenia gravis (gMG) and warm autoimmune hemolytic anemia. J&J is also testing Imaavy for systemic lupus erythematosus . Data from a Phase 2 trial demonstrated significant reduction in disease activity , according to a June readout. A late-stage study in this indication is ongoing. Imaavy is also currently in development for Sjogren’s disease, fetal and neonatal alloimmune thrombocytopenia and idiopathic inflammatory myopathy. Also in the FcRn arena is argenx. The biotech’s only commercial franchise is the FcRn inhibitor Vyvgart , approved for gMG. A subcutaneous formulation of the drug, called Vyvgart Hytrulo , is approved for gMG and chronic inflammatory demyelinating polyneuropathy. The biotech continues to study the asset in other immunology indications, such as immune thrombocytopenia and Graves’ disease. Other companies targeting FcRn include Immunovant with imeroprubart, also known as IMVT-1402 , which is in Phase 3 studies for a range of autoimmune conditions—though the company recently stopped pursuing lupus after a mid-stage failure —and UCB Pharma with the FDA-approved Rystiggo. Mahajan agrees that FcRn is currently one of the most valuable immunology targets, offering “the broadest theoretical pipeline-in-a-product potential.” STAT6 could pave path to ‘oral Dupixent’ Another immunology target attracting significant attention is STAT6 , a signaling pathway that plays a central role in the activity of B cells—the immune players that produce antibodies. Faulty regulation of this pathway is known to result in a host of disorders, such as atopic dermatitis, asthma and food allergies. STAT6 “is clearly of interest to people,” William Blair’s Phipps told BioSpace , referring to the target’s potential to produce an “oral Dupixent.” That blockbuster antibody targets IL-4 and IL-13 , both of which lie upstream of STAT6 in the immune cascade. One leader in this space is Kymera Therapeutics, which is working on the orally available degrader KT-621, being tested for atopic dermatitis and asthma. Phase 1b data presented in March demonstrated “ deep STAT6 degradation ” at both 100-mg and 200-mg dose levels in patients with moderate-to-severe atopic dermatitis, with median reductions of 94% in the skin and 98% in the blood, Kymera said at the time. The candidate also elicited “robust reductions” in several disease-relevant type 2 inflammatory blood biomarkers. The early-stage study’s primary endpoint is safety, which the March readout found to be “favorable,” according to a company presentation . There were no serious or severe adverse events, nor did any of the patients drop out due to treatment-emergent adverse events (TEAE). Data from the Phase 2b BROADEN2 study are expected by the end of this year. Also in the STAT6 race are Nurix Therapeutics and powerhouse partner Sanofi. Together, the companies are advancing the oral STAT6 degrader SAR448272/NX-3911, which last month advanced into Phase 1 development for type 2 inflammatory diseases. Sanofi in April 2025 licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases for $15 million upfront and the possibility of up to $465 million in milestones. The companies first came together in December 2019 in a multi-year collaboration to advance targeted degraders in which Sanofi paid Nurix $55 million upfront. Next-gen IL-13/IL-4 blockers seek to improve on Dupixent While the STAT6 developers seek to package the Dupixent magic in a pill, another group of drugmakers is developing next-gen molecules that could improve upon the blockbuster drug’s already-impressive efficacy profile, H.C. Wainwright Senior Analyst Mitchell Kapoor told BioSpace in an email. Among the companies leading this charge are Eli Lilly and LEO Pharma, he said, which own Ebglyss and Adbry , respectively. Like Dupixent, both of these medicines are antibodies that disrupt the IL-13/IL-4 pathway and are approved to treat moderate-to-severe atopic dermatitis. Many others still in the clinic could not only improve upon Dupixent’s efficacy but also allow for less frequent dosing, Kapoor said. These include Aclaris Therapeutics’ bispecific therapy ATI-052, which blocks IL-4 and TSLP, another crucial immune signaling molecule. Phase 1a data in January showed favorable safety outcomes for the asset, as well as a potential “best-in-class” pharmacokinetic profile, according to the biotech. Aclaris expects topline data from Phase 1b proof-of-concept trials in atopic dermatitis and asthma in the second half of this year. Kapoor also pointed to Sanofi, which is taking a similar approach with the bispecific therapy lunsekimig, which works by targeting TSLP and IL-13. In April, the company announced mid-stage data showing that lunsekimig improved symptom burden in patients with asthma and rhinosunisitis, but failed to ease severity in a Phase 2b trial of atopic dermatitis. Sanofi is also testing the asset for chronic obstructive pulmonary disease (COPD). Pfizer, meanwhile, is developing the trispecific molecule tilrekimig, which targets IL-13, IL-4 and TSLP. A Phase 2 readout in March demonstrated statistically significant improvements in eczema severity at 16 weeks, encouraging the pharma to advance the asset into late-stage studies for atopic dermatitis in 2026. Tilrekimig is also being studied for asthma and COPD. Drug development Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.” April 7, 2026 · 2 min read · Annalee Armstrong Read more IL-17/IL-23 still fertile for innovation after several approvals Arguably among the most-addressed disease drivers in the immunology space are IL-17 and IL-23 , cytokines that lie close to each other on the inflammation signaling cascade. Secreted by immune cells in response to certain stimuli, IL-23 is more upstream and works to activate helper T cells, which in turn produce IL-17. Both cytokines help kick off the inflammatory response—and therefore offer attractive opportunities for drugmakers to intervene. Indeed, some of the industry’s biggest immunology players and franchises target IL-23 or IL-17, including Novartis’ Cosentyx , Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi . But while there are already several drugs on the market addressing these targets, Phipps argued that there is still a lot of room for development in the space as companies make headway with oral options. H.C. Wainwright’s Kapoor agreed, pointing in particular to IL-23, which he said “remains attractive” as the lead target in psoriasis as novel products emerge with more convenient dosing schedules. In March, for instance, J&J won the FDA’s approval for Icotyde, an oral IL-23 receptor blocker indicated for severe plaque psoriasis. There’s also Takeda, which is developing zasocitinib, an oral drug that inhibits IL-23 signaling. Zasocitinib is under FDA review for moderate-to-severe plaque psoriasis with a decision expected early next year. Meanwhile, Ascletis Pharma is advancing an investigational oral IL-17 inhibitor called ASC50 for psoriasis. Phase 1 data presented in December 2025 showed strong target engagement, painting what CEO Jinzi Jason Wu claimed is a “best-in-class” profile. But even as pills start entering the market, “Skyrizi’s continued growth is pushing back on the idea that oral drugs will inevitably displace injectable biologics,” Kapoor said. “Patients continue to choose injections because infrequent dosing can actually be more convenient than taking a pill every day.” This is especially true for patients with controlled disease, he noted, who want to think about their conditions “as little as possible.” Oruka Therapeutics is pushing this particular hypothesis to a “logical extreme,” he continued, with its injectable IL-23 inhibitor ORKA-001 that could potentially be dosed once a year, according to the biotech . The asset set to enter Phase 3 development in the first half of 2027 . Approvals J&J Wins FDA Nod for First Targeted Oral Anti-IL-23 Therapy for Plaque Psoriasis Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu. March 18, 2026 · 2 min read · Tristan Manalac Read more