RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), PRIME (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Fast Track (United States)

Structure/Sequence

Sequence Code 25650568H

Source: *****

Sequence Code 25650570L

Source: *****

Clinical Trials associated with Emapalumab-LZSG

NCT07538336

/ Not yet recruitingPhase 2IIT

Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD).
ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD.
The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.

Start Date02 Nov 2026

Sponsor / Collaborator

The University of California, San Francisco

NCT06996119

/ Not yet recruitingPhase 1IIT

Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation

This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor [peripheral blood stem cell] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.

Start Date25 May 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07567014

/ Not yet recruitingPhase 2IIT

A Phase II Study of the Interferon Gamma Inhibitor Emapalumab for Prophylaxis of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome in Patients With Lymphoma and Multiple Myeloma Receiving Bispecific T-Cell Engagers

The purpose of this study is to evaluate emapalumab as a prophylactic therapy in preventing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with hematologic malignancies receiving bispecific antibodies (BsAbs) as outpatient. The primary objectives of this study are to evaluate the efficacy, safety, and feasibility of prophylaxis with the interferon gamma (IFN-У -γ) inhibitor Emapalumab in preventing CRS and/or ICANS in patients receiving bispecific antibody therapy for hematologic malignancies.

Start Date11 May 2026

Sponsor / Collaborator

NYU Langone Health

100 Clinical Results associated with Emapalumab-LZSG

100 Translational Medicine associated with Emapalumab-LZSG

100 Patents (Medical) associated with Emapalumab-LZSG

Literatures (Medical) associated with Emapalumab-LZSG

10 Mar 2026·Blood Advances

Emapalumab use in malignancy-associated hemophagocytic lymphohistiocytosis in the United States: the REAL-HLH study

Article

Author: Isakoff, Michael ; Carter, John ; Leiding, Jennifer W. ; Ray, Anish K. ; Intzes, Stefanos ; Tandra, Anand ; Oladapo, Abiola ; Hermiston, Michelle L. ; Gidvani-Diaz, Vinod K ; Hays, Allyson ; Rothman, Jennifer A. ; Cooper, Robert ; Sarangi, Susmita ; Walkovich, Kelly J. ; Satwani, Prakash ; Ward, Brant ; Chandrakasan, Shanmuganathan ; Henry, Michael ; Panigrahi, Arun ; Jordan, Michael B. ; Isakoff, Michael S. ; Yee, John D. ; Draper, Lauren ; Bhatt, Sima ; Bhatla, Deepika ; Gloude, Nicholas ; Hinson, Ashley P. ; Saldaña, Blachy Dávila ; Modica, Renee ; Pednekar, Priti ; Weinstein, Joanna ; Patel, Sachit A. ; Behrens, Edward M. ; Eckstein, Olive S. ; Hanna, Rabi ; Nakano, Taizo A. ; Chien, May ; Gulati, Nitya ; Allen, Carl E. ; Riskalla, Mona ; Haines, Hilary ; Zoref-Lorenz, Adi ; Baker, Ashley

Abstract:

Malignancy-associated hemophagocytic lymphohistiocytosis (mHLH), a hyperinflammatory syndrome, has poor prognosis and no standard therapy. Emapalumab, a fully human monoclonal antibody that neutralizes the proinflammatory cytokine interferon gamma, is approved for treating primary hemophagocytic lymphohistiocytosis (pHLH). REAL-HLH, a retrospective chart review conducted across 33 US hospitals, evaluated real-world treatment patterns and outcomes in patients treated with ≥1 dose of emapalumab between 20 November 2018 and 31 October 2021. Data are presented for the subset of patients with mHLH. Overall, 51 of 105 (48.6%) patients were categorized as having secondary HLH, of which 17 of 51 patients had HLH associated with an underlying malignancy (mHLH). At HLH diagnosis, the median age (range) was 15.0 (3.0-27.0) years, 6 of 14 (42.9%) patients with available data had a positive Optimized HLH Inflammatory index, indicating pathologic inflammation; 9 of 17 (52.9%) had infections; and 10 of 17 (58.8%) received emapalumab in an intensive care unit. Emapalumab was primarily initiated for treating refractory (10/17; 58.8%) or progressive (3/17, 17.7%) disease. Most patients received HLH-related therapies before (16/17; 94.1%) and/or concurrent with (15/17; 88.2%) emapalumab. Treatment with emapalumab-containing regimens normalized most key laboratory parameters and maintained normal values for others (fibrinogen [11/13; 84.6%], absolute neutrophil count [6/10; 60%], and chemokine ligand 9 [7/8; 87.5%]) per physician assessment. Overall survival at the end of follow-up and 12-month survival probability from emapalumab initiation were 23.5% and 22.1%, respectively. In conclusion, emapalumab-containing regimens normalized, improved, or maintained normal values for most laboratory parameters in patients with mHLH. Future studies are warranted to establish appropriate emapalumab dosing and utility in this high-risk population.

01 Feb 2026·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Clinically validated assay for rapid determination of type I and type II interferon activity in systemic inflammatory diseases

Article

Author: Weng, Rachel ; Yue, Jian ; Huang, Zhengping ; Wysocki, Christian ; Andzelm, Milena M ; Lam, Michael T ; Rimland, Casey A ; Ramanathan, Anusha ; Chou, Janet ; Platt, Craig D ; Hsu, Evan E ; Abraham, Roshini S ; Chang, Joyce C ; Henderson, Lauren A ; Lee, Pui Y ; Basu, Amrita ; Alhezam, Musaab A ; Son, Mary Beth F ; Wobma, Holly ; Jiang, Connie L ; Okada, Seigo ; LeSon, Courtney E ; Brodeur, Kailey E ; Peng, Xiao P

BACKGROUND:

Type I interferons (IFN-I) and type II interferon (IFN-γ) contribute to the pathogenesis of inflammatory diseases, but measurement of these cytokines remains challenging in the clinical setting.

OBJECTIVE:

We aimed to develop a clinical test that rapidly captures the activity of IFN-I and IFN-γ.

METHODS:

We compared RNA sequencing data from healthy controls and patients with macrophage activation syndrome, multisystem inflammatory syndrome in children, and systemic lupus erythematosus to evaluate biomarkers of IFN-I and IFN-γ signaling. We utilized a flow cytometry assay to measure interferon-inducible markers. The findings were verified by a clinical laboratory that independently developed and validated this assay.

RESULTS:

We identified CD274 (programmed death ligand 1, or PD-L1) as a biomarker of IFN-γ signaling and confirmed CD169 (SIGLEC-1) as a readout of IFN-I activity. We utilized a flow cytometry assay to quantify CD169 and CD274 expression on monocytes and demonstrated the validity of this method for rapid screening of interferon dysregulation in patients with various inflammatory diseases including, among others, macrophage activation syndrome, hemophagocytic lymphohistiocytosis, multisystem inflammatory syndrome in children, systemic lupus erythematosus, juvenile idiopathic arthritis, and juvenile dermatomyositis. We further demonstrated the utility of this test for assessment of interferon dysregulation in monogenic inflammatory diseases and for efficacy monitoring of medications that target the interferon pathways including Janus kinase inhibitors, emapalumab, and anifrolumab. Finally, we outlined the steps of assay validation and clinical implementation, and we showed reproducible findings in a clinical laboratory.

CONCLUSION:

Flow cytometry analysis of CD169 and CD274 is an effective method to rapidly quantify IFN-I and IFN-γ activity in the clinical setting.

01 Feb 2026·Transplantation and Cellular Therapy

Management Practices of CAR T-cell-Related Inflammatory Toxicities: A Survey of Pediatric CAR T-cell Providers

Article

Author: Ombrello, Amanda K ; McNerney, Kevin O ; Chaudhury, Sonali ; Diorio, Caroline ; Graham, Andrea K ; Maude, Shannon L ; Talleur, Aimee C ; Shah, Nirali N ; Gardner, Rebecca A ; Sanchez-Pinto, Lazaro N ; Schultz, Liora M ; Annesley, Colleen

Immune related adverse events (IRAE) are the most common nonhematologic adverse effects of chimeric antigen receptor (CAR) T-cell therapies. These events can be severe and refractory to upfront management. Tocilizumab is currently the only FDA-approved drug for the treatment of CAR T-cell induced inflammatory toxicities. However, an increasing number of anti-inflammatory therapies are now utilized for prevention and treatment of severe or refractory IRAE. Emerging evidence suggests the potential benefit of prophylactic or preemptive use of anti-inflammatory agents to mitigate severe toxicities. Guidance on the use of alternative anti-inflammatory therapies, preventative strategies, and management of refractory CAR T-cell toxicities is limited, with varying recommendations in society guidelines and the FDA labels for tisagenlecleucel and tocilizumab. Furthermore, there is a lack of pediatric-specific guidance. The primary objective of this study was to characterize CD19-CAR T-cell toxicity management practices for children and young adults with B-acute lymphoblastic leukemia by pediatric CAR T prescribers. A survey consisting of 28 questions focused on CAR T-cell toxicity management practices was distributed to pediatric CAR T-cell treatment centers with responses received between February and March 2024. Sixty unique responses with adequate data were received from 46 institutions. Forty-four respondents (73%) indicated using a preemptive treatment approach, defined as immunomodulatory therapy initiated for low grade toxicity to prevent the development of worsening toxicity, of which 33 (75%) used for high-risk patients and 9 (21%) used for all patients. Conversely, only 8 (14%) respondents indicated using a prophylactic approach defined as immunomodulatory therapy initiated prior to the onset of inflammatory toxicities. The most common feature leading to a patient being considered high-risk was high disease burden. Fifteen percent of respondents initiated tocilizumab for cytokine release syndrome (CRS) at grade 1, 48% at grade 2, and 18.3% at grade 3. Steroids were initiated at grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) in 43% of respondents and grade 3 in 28% of respondents. Most respondents had experience using alternative anti-inflammatory therapies, including anakinra (80%), siltuximab (50%), ruxolitinib (28%), emapalumab (22%), and dasatinib (15%). Anakinra was most often used for management of refractory CRS, refractory ICANS, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). Most respondents indicated a need to prospectively study anakinra and emapalumab for treatment and/or prevention of CAR T inflammatory toxicities. Themes identified through analysis of semi-structured questions included the need for guidelines on use of alternative therapies, early preventative treatments, initial management of IRAE, and refractory IRAE management. This survey highlights significant practice variability in timing of initiation of CRS and ICANS treatment, frequent use of alternative anti-inflammatory therapies for CAR T toxicity management, and a consensus regarding the need for prospective study of therapies including anakinra and emapalumab. Survey results indicate a need for guidelines on management of CAR-induced inflammatory toxicities at their onset and in the refractory setting, and on the use of alternative therapies.

News (Medical) associated with Emapalumab-LZSG

18 Mar 2026

·www.prnewswire.com

Results from EMBRACE Phase 2a study of emapalumab in interferon-gamma-driven sepsis presented at ISICEM

Primary endpoint: improvement in organ function observed in 60% of patients receiving high-dose emapalumab vs 40% with standard of care plus placebo 28-day mortality: 40% in the high-dose emapalumab group vs 52% in the placebo group Biomarker response: high-dose emapalumab associated with faster reduction of pro-inflammatory biomarkers linked to interferon-gamma signalling Emapalumab was generally well tolerated STOCKHOLM, March 18, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that topline results from the Phase 2a EMBRACE study (NCT06694701), evaluating Gamifant® (emapalumab) in patients with interferon-gamma (IFNγ)-driven sepsis (IDS), were presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) by Professor Evangelos J. Giamarellos-Bourboulis, President of the Hellenic Institute for the Study of Sepsis. The EMBRACE study was sponsored by the Hellenic Institute for the Study of Sepsis (HISS) as part of a research collaboration with Sobi. "These findings support the concept that sepsis is not a single disease but a syndrome with different biological drivers," said Prof. Evangelos J. Giamarellos-Bourboulis, principal investigator of the EMBRACE study. "The EMBRACE study explores a precision medicine approach in which patients with interferon-gamma-driven immune dysregulation may benefit from targeted immunotherapy." Sepsis is a life-threatening condition caused by a dysregulated immune response to infection that can lead to organ failure and death. The EMBRACE Phase 2a study evaluated emapalumab in patients with IDS identified through biomarker profiling. "Sepsis represents a leading cause of mortality worldwide and treatment options remain limited[i]. The interferon-gamma driven sepsis endotype shows an elevated mortality risk compared to all sepsis patients," said Lydia Abad-Franch, Chief Medical Officer and Head of Research & Development at Sobi. "We are encouraged by these data and are discussing the next steps in the clinical program with regulatory authorities to gather further evidence to evaluate a potential new indication for emapalumab." Emapalumab was generally well tolerated in the EMBRACE study. The safety observations were consistent with the known safety profile of emapalumab, with infections the most common events observed, and no new safety signals identified. About sepsis and IFNγ-driven sepsis (IDS) Sepsis is a serious condition in response to an infection that can lead to organ failure and is a leading global cause of mortality. A recent large study, published in eBioMedicine in 2024 describes different sepsis endotypes, suggesting varying endotypes require differentiated treatment strategies. Approximately 20% of the patients studied are of the newly described IFNγ-driven sepsis (IDS) endotype. About the EMBRACE study The EMBRACE study (NCT06694701) was a Phase 2a, double-blind, randomised controlled trial conducted at 24 sites in Greece. The study was sponsored by the Hellenic Institute for the Study of Sepsis (HISS) as part of a research collaboration with Sobi. The trial investigated whether Gamifant, an anti-IFNγ antibody, can improve clinical outcomes in patients with the interferon gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterised by elevated levels of CXCL9 and detectable IFNγ and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aimed to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms (a total of 75 patients enrolled), two groups receiving Gamifant, (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of-care treatment. The primary endpoint was a ≥1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFNγ, and CXCL9. About Gamifant Gamifant® (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. When IFNγ is secreted in an uncontrolled manner, hyperinflammation occurs within the body. Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). In the USA, Gamifant is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Gamifant is also approved in the US for the treatment of adult and paediatric (newborn and older) patients with haemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still's disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. About HISS The Hellenic Institute for the Study of Sepsis (HISS) is a non-profit, academic institute which fosters the activities of young researchers in the fields of systemic inflammation and sepsis. Since 2010, HISS has published 125 peer-reviewed publications including the publication of guidelines for sepsis in Greece, led the organisation of 15 conferences, and of 35 clinical studies. HISS focuses on precision immunotherapy and is the Sponsor of the major randomised controlled trials SAVE-MORE and ImmunoSep. The data from these studies have been published in journals such as Nature Medicine and JAMA. 2,3. For more information, please visit . About Sobi® Sobi ® is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2025 revenue amounted to SEK 28 billion. Sobi's share (STO: SOBI) is listed on NASDAQ Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. [i] Rudd KE et al. Global, regional, and national sepsis incidence and mortality, 1990–2017. The Lancet, 2020;395:200–211. CONTACT: Visiting address Norra Stationsgatan 93A, Stockholm +46 8 697 20 00 [email protected] This information was brought to you by Cision The following files are available for download: 21% more press release views with Request a Demo

Clinical ResultPhase 2ImmunotherapyDrug Approval

18 Mar 2026

·endpoints.news

Ionis delays prion disease readout; Arvinas' Parkinson's biomarker data

Plus, news about Eledon, Sobi, Ovid and CytomX: 🗓️ Ionis updates prion disease study timelines: The California oligonucleotide powerhouse has pushed back the primary completion of its Phase 1/2a trial to February 2027, from an earlier goal of July 2025, according to an update to the US federal trials database. Ionis said in a letter to the prion disease community this week that it is adding a third dosing regimen, of about 20 additional patients, to the clinical trial, named PrProfile. “The decision to expand PrProfile is based on a review of interim data showing an encouraging safety and tolerability profile, and that ION717 is engaging with its target biology (i.e., prion protein),” Ionis wrote in the letter. Misfolded proteins lead to the fatal brain disease. Other biotechs such as Gate Bioscience are in this space. — Kyle LaHucik 📊 Arvinas says PROTAC reduced biomarker in Parkinson’s disease: In a Phase 1 study of Parkinson’s patients, the company’s program ARV-102 reduced LRRK2 levels in the cerebrospinal fluid by “approximately 50% or greater” after four weeks. Patients received one of three doses ranging from 20 mg to 80 mg. — Max Gelman 📊 Eledon shares more type 1 diabetes data: The biotech’s immunosuppressant candidate, tegoprubart, was given to 12 patients with diabetes undergoing an islet transplant in an investigator-sponsored trial. All ten patients who were four weeks post-transplant achieved insulin independence, and there were no cases of rejection. The data add to previous results reported in 2024. Eledon is also advancing tegoprubart for patients receiving a kidney transplant . — Ayisha Sharma 📊 Sobi to advance sepsis program following Phase 2a data: The Swedish company said high-dose emapalumab improved organ function in 60% of patients with interferon-gamma driven sepsis, versus 40% for standard of care plus placebo. But the trial, which enrolled 75 patients across three arms, was not powered for statistical significance, a Sobi spokesperson said in an email. The company is discussing a path forward with regulators. — Ayisha Sharma 💰 Ovid reports safety data, raises cash: The biotech’s 7 mg dose of OV329 showed “favourable safety and tolerability” in a Phase 1 study in healthy volunteers. Ovid plans to advance the candidate to a Phase 2 trial in focal onset seizures. The company is also raising $60 million in private placement to expand into two indications: tuberous sclerosis complex seizures and infantile spasms. — Ayisha Sharma 💰 CytomX prices $250M offering: The biotech will use the cash to fund its antibody-drug conjugate varsetatug masetecan, or Varseta-M. Earlier this week, CytomX read out late-line colorectal cancer data for Varseta-M, causing its stock price to rise by about 45%. — Max Gelman

Clinical ResultPhase 1Phase 2Oligonucleotide

18 Feb 2026

·www.prnewswire.com

Sobi Capital Markets Day 2026: Bringing brilliant ideas to life and building the next chapter with ambition to deliver SEK 55bn by 2030

STOCKHOLM, Feb. 18, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today hosts its Capital Markets Day, where senior management will provide an update on the company's strategy and outline its new mid-term outlook, aiming to achieve SEK 55bn revenue by 2030, while building a resilient platform for sustained growth beyond 2030. Sobi aims to have an adjusted EBITA margin in the upper 30s percentage of revenue by 2030. Sobi has delivered strong and profitable growth in recent years, transforming and diversifying its portfolio and positioning the company to deliver on six major launches. Additionally, Sobi is advancing priority development programs enabling longer term growth and continuing its international expansion. "Sobi today is a stronger, more global and more scientifically driven company," says Guido Oelkers, CEO of Sobi. "We have delivered on our commitments, built a diversified, robust foundation for future growth, and are entering the next phase of expansion with multiple launches and compelling opportunities to unlock growth well beyond 2030." Highlights of the Capital Markets Day Sobi shares its ambition to reach SEK 55bn in revenues by 2030, effectively doubling the company revenue driven by six major launches, continued strong performance of strategic products, and international expansion. Sobi outlines major launches either ongoing or in preparation, expected to drive the majority of growth to 2030, including Altuvoct®, Gamifant®, Aspaveli®, Tryngolza®, NASP, and pozdeutinurad, across haematology, immunology, and specialty care. Deep dives demonstrate Sobi's scientific leadership in: Uncontrolled and progressive gout and two potentially transformative treatment innovations in an area of high unmet patient needs. Severe hypertriglyceridemia, where acute pancreatitis is a major risk and a severe medical emergency, and ApoC-III inhibition with olezarsen has shown significant and meaningful reductions in acute pancreatitis risk. Precision medicine in sepsis: In biomarker-selected patients with interferon gamma-driven sepsis (the proof-of-concept EMBRACE study), Sobi will share topline data for empalumab demonstrating improvement in SOFA-based organ function (achieving primary endpoint at end of treatment in 60% patients receiving high dose emapalumab vs 40% in the standard of care plus placebo arm). High dose emapalumab additionally showed a 12-percentage point absolute mortality reduction after 28-days (40% mortality in the high dose emapalumab arm vs 52% in the standard of care plus placebo arm). Additional information provided New peak sales expectations for the following products: Haemophilia A franchise (Altuvoct and Elocta) greater than SEK 10bn, Aspaveli between SEK 7-10bn, Gamifant in HLH between SEK 5-7bn, NASP between SEK 4-6bn, Tryngolza greater than SEK 10bn, pozdeutinurad greater than SEK 10bn and Gamifant in IDS greater than SEK 10bn. R&D expenses to remain between 11-14 per cent of sales on a given year between now and 2030. Agenda in brief The Capital Markets Day includes presentations from Sobi's executive leadership on strategy, pipeline and innovation, commercial opportunities and financial outlook as well as disease deep dives with experts and leaders in their respective fields, and a concluding Q&A session. Pre-registration for online attendance: click here A recording of the presentations and supporting materials will be made available on . Sobi Sobi® is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2025 revenue amounted to SEK 28 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CET on 18 February 2026. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB 21% more press release views with Request a Demo

Clinical Result

100 Deals associated with Emapalumab-LZSG

External Link

KEGG	Wiki	ATC	Drug Bank
-	Emapalumab-LZSG	L04AA39	DB14724

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Macrophage Activation Syndrome	United States	NovImmune SA	27 Jun 2025
Systemic onset juvenile chronic arthritis	United States	NovImmune SA	27 Jun 2025
Lymphohistiocytosis, Hemophagocytic	United States	NovImmune SA	20 Nov 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	United States	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Japan	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Belgium	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Canada	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Czechia	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	France	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Germany	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Italy	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Netherlands	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	Poland	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05744063 (CTgov)	Phase 4	Lymphohistiocytosis, Hemophagocytic	13	Emapalumab	hltmckszdy = hfwcdfmhdh mvlhjrhdsj (clrmxurbte, zodfcskctp - fekvpbpnen) View more	-	13 Mar 2026
NCT05001737 (EMERALD \| NI-0501-14, CTgov)	Phase 3	Systemic onset juvenile chronic arthritis \| Fibrous Dysplasia, Polyostotic \| Lymphohistiocytosis, Hemophagocytic ... View more	33	Emapalumab (Cohort 1 (sJIA and AOSD))	xaujvmetpq = fmwtkazqda cpomquecag (zkapjwqdrn, oainjwnrlq - jrwxplapga) View more	-	19 Feb 2026
NCT05001737 (EMERALD \| NI-0501-14, CTgov)	Phase 3		33	Emapalumab (Cohort 2 (SLE))	xaujvmetpq = feniwfpgdk cpomquecag (zkapjwqdrn, baclsyxegk - zfcsfioszv) View more	-	19 Feb 2026
NCT03311854 (NI-0501-06, ACR2025)	Phase 2	Macrophage Activation Syndrome	39	Emapalumab (EMERALD (NCT05001737))	qbtpxrzupm(mcsrjlyydl) = tdgobsstqp wkvdknfzju (wuydosyvpa ) View more	Positive	24 Oct 2025
NCT03311854 (NI-0501-06, ACR2025)	Phase 2	Macrophage Activation Syndrome	39	Emapalumab (NI-0501-06 (NCT03311854))	hwheudubww(tnldqhajld) = yegbnjvmnd awrwgdjooj (ifzpsczwkj )	Positive	24 Oct 2025
NCT03311854 (NI-0501-06, ACR2025)	Phase 2	Macrophage Activation Syndrome	39	Emapalumab	dkrdobgsnx(ymoehwhjmt) = ujsbkrmcny antxqxecmm (bdbcxwniuy, 37.2 - 69.9) View more	Positive	24 Oct 2025
NCT03311854 \| NCT05001737 (NI-0501-14, FDA_CDER) Manual	Not Applicable	Systemic onset juvenile chronic arthritis \| Lymphohistiocytosis, Hemophagocytic \| Macrophage Activation Syndrome	39	GAMIFANT	rmlqqifjwq(koqtotlqjr) = btqirargzm ygyxrgtsgt (ozzgnriiux, 37.2 - 69.9) View more	Positive	27 Jun 2025
NCT03311854 (NI-0501-06, EULAR2025)	Phase 2	Macrophage Activation Syndrome	39	Emapalumab (MAS in Still's disease + Inadequate response to high-dose glucocorticoids)	gulwotivmx(trgoxwuwdt) = bckmzrzlso iafrntcazh (ndivxktruk )	Positive	11 Jun 2025
PS2153 (EHA2025)	Not Applicable	Cytokine Release Syndrome IFN-γ \| TNF-α \| IL-2 ... View more	38	Emapalumab	rmftbczusi(efkxkplgem) = 8 patients died (2 from disease relapse/progression, 4 from severe infections, and 2 from septic shock associated with CRS) fiozvakvpc (zpfwlsxtqc ) View more	Positive	14 May 2025
NCT03311854 (NI-0501-06, ACR2024)	Phase 3	Cardiovascular Diseases	39	Emapalumab	pajjlkvnab(kqljmmxovw) = blfhimhzkh udfrxzjoyv (bprxvugebh, 37.2 - 69.9) View more	Positive	10 Nov 2024
NCT04731298 (P449, CTgov)	Phase 2	Graft dysfunction	2	Emapalumab (Emapalumab Treated)	dstkrsjsnk = dszwbceuwc ylboqvbwat (fmiazertnj, oiexrfhxbq - cbzawojybu) View more	-	28 Dec 2023
NCT04731298 (P449, CTgov)	Phase 2	Graft dysfunction	2	emapalumab (Non-emapalumab Treated)	dstkrsjsnk = tqsfmwbnej ylboqvbwat (fmiazertnj, eloqrrxnfl - rpdqgospxk) View more	-	28 Dec 2023
NCT04765553 (CTgov)	Phase 1	Rare Diseases	8	NI-0501 (Emapalumab)	aanolorzyb(xzbgqglayn) = visbenxjit teghusfcxw (ijkbeectlh, raqeyplvdx - iyasueygsd) View more	-	24 Nov 2023
NCT04765553 (CTgov)	Phase 1	Rare Diseases	8	Saline (Placebo)	dbodymuypq = wijpwjiabt qksperoxdc (mlrkvzimtb, imhtxznrqe - xbrspxyuzc) View more	-	24 Nov 2023

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