rosnilimab (ANB030) / First Tracks Biotherapeutics - LARVOL DELTA

Spatial Transcriptomics reveals Rosnilimab-induced immune and stromal niche remodeling in Rheumatoid Arthritis (ACR Convergence 2026) - No abstract available

Stroma • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Rosnilimab Selectively Depletes Pathogenic T Cells and Downregulates Clinically Relevant Immune Pathways in Rheumatoid Arthritis: A Translational Analysis of Blood and Synovial Tissue from the Phase 2B Trial (ACR Convergence 2026) - No abstract available

Clinical • P2b data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Plenary I: Rosnilimab Selectively Depletes Pathogenic T Cells and Downregulates Clinically Relevant Immune Pathways in Rheumatoid Arthritis: A Translational Analysis of Blood and Synovial Tissue from the Phase 2B Trial (ACR Convergence 2026) - No abstract available

Clinical • P2b data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Rosnilimab (Pathogenic T cell depleter) (GlobeNewswire) - "Currently assessing ROE-maximizing strategic options to progress the potential development of rosnilimab in rheumatoid arthritis (RA) and other indications."

Clinical • Immunology • Rheumatoid Arthritis

Breaking and Making Tolerance: The PD-1/PD-L1 Axis in Lupus Nephritis. (PubMed, Immunol Invest) - "PD-1 agonism (rosnilimab, PD-L1-Fc, nanoparticle delivery) offers promise, but the pathogenic activity of PD-1⁺ effector T cells argues against a uniform approach. Our framework provides a basis for patient stratification, biomarker development, and combination strategies, ultimately guiding a shift from broad immunosuppression to tailored therapy in LN and informing future translational research."

IO biomarker • Journal • Review • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • CD4 • CD8 • GZMB • IFNA1 • IFNG • IL12A

Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety and Translational Proof of Mechanism in RENOIR, a Phase 2B Trial in Moderte-to-Severe Rheumatoid Arthritis (EULAR 2026) - P2 | "(Table 2) Conclusions In this phase 2B clinical trial, rosnilimab demonstrated efficacy, safety, and tolerability for seropositive RA, even among people who had received multiple previous b/tsDMARDs. These data provide clinical proof-of-concept for clinical efficacy for depletion of pathogenic T cells and support further exploration of rosnilimab in RA."

Clinical • P2b data • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Varicella Zoster • CRP

Rosnilimab Selectively Depletes Pathogenic T Cells and Downregulates Clinically Relevant Immune Pathways in Rheumatoid Arthritis: A Translational Analysis of Blood and Synovial Tissue from the RENOIR Phase 2B Trial (EULAR 2026) - P2 | "Collectively, these findings highlight rosnilimab as a novel therapeutic approach with the potential to address fundamental mechanisms of disease in RA and other autoimmune and inflammatory conditions. Image(s), graphic(s), or table(s) Figure 1 Figure 2"

Clinical • IO biomarker • P2b data • Immunology • Inflammatory Arthritis • Orthopedics • Rheumatoid Arthritis • Rheumatology • CXCL13 • IL6 • PD-1

Rosnilimab (Pathogenic T Cell Depleter) (GlobeNewswire) - "Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026. The agency provided constructive feedback on a registrational Phase 3 path in rheumatoid arthritis (RA), a disease with significant remaining patient unmet need. Currently assessing ROE-maximizing strategic options that may include a global partnership, out-license or asset financing to progress the potential development of rosnilimab in RA and other indications."

Commercial • FDA event • Rheumatoid Arthritis

AnaptysBio Plans First Tracks Spin-Off as Jemperli Royalties Surge, Buybacks Possible (Yahoo Finance) - "...The company expects to create a new company, First Tracks Biotherapeutics, within 'a month or two'. Under the plan, the existing AnaptysBio name will remain with a lean, royalty-based business, while the majority of employees, labs, and development-stage assets will transfer to First Tracks....First Tracks will house development programs (ANB033, rosnilimab, ANB101) and receive a large portion of AnaptysBio’s ~$310 million cash..."

Commercial • dMMR • MSI-H • Endometrial Cancer

Rosnilimab (Pathogenic T Cell Depleter) (GlobeNewswire) - "Anticipate providing an update on advancement of rosnilimab in RA, which would be funded by strategic or other outside sources of capital, in Q2 2026."

Clinical • Rheumatoid Arthritis

Rosnilimab: “69% (220/318) achieved LDA at week 14 (NRI)”; Rheumatoid arthritis (44th Annual J.P. Morgan Healthcare Conference, AnaptysBio)

P2b data • Rheumatoid Arthritis

Rosnilimab: “69% (220/318) achieved LDA at week 14 (NRI)”; Rheumatoid arthritis (44th Annual J.P. Morgan Healthcare Conference, AnaptysBio)

P2b data • Rheumatoid Arthritis

Anaptys Announces Phase 2 Trial of Rosnilimab Did Not Meet Primary or Secondary Endpoints at Week 12 in Moderate-to-Severe Ulcerative Colitis (GlobeNewswire) - "...Lack of adequate efficacy at Week 12 does not support further development of rosnilimab in UC and trial will be discontinued....Regardless of prior treatment, rosnilimab performed no better than placebo at Week 12, with clinical remission achieved by 7% of patients receiving rosnilimab 400mg Q4W or 800 mg Q2W, and 5% and 4% of patients achieving endoscopic remission, respectively. While preliminary data suggest an increase in remission rates between Week 12 and Week 24, Week 24 remission rates did not meet our six-month target product profile."

P2 data • Trial termination • Ulcerative Colitis

Top-line data through Week 12 of global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced) on track for November/December 2025 (GlobeNewswire) - "Will report data on primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo Score (mMS) and key secondary endpoints, such as clinical response and remission on mMS."

P2 data • Ulcerative Colitis

Anaptys Announces New Positive Phase 2b Trial Results for Rosnilimab in Rheumatoid Arthritis at ACR Late-Breaking Oral Presentation (GlobeNewswire) - "As previously reported, at Week 12, statistically significant and clinically meaningful efficacy was achieved on the primary endpoint DAS28-CRP, as well as for ACR20, for all doses, including monthly doses (Q4W); At Week 28, CDAI LDA, CDAI remission and ACR50/70 rates continued to improve independent of prior treatments, including anti-TNFα, anti-IL6R or JAK inhibitors; Similar effects were seen for patients previously treated with at least two prior biologic or targeted synthetic disease-modifying antirheumatic drug classes (b/tsDMARDs), particularly at the mid (400mg Q4W) and high (600mg Q2W) doses..."

Late-breaking abstract • P2b data • Rheumatoid Arthritis

Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety, and Translational Proof of Mechanism in a Rheumatoid Arthritis Phase 2B Trial (ACR Convergence 2025) - P2 | "Rosnilimab selectively and potently depletes pathogenic T cells in RA leading to clinically meaningful and durable responses. These data support further exploration of rosnilimab in RA. Figure 1."

Clinical • Late-breaking abstract • P2b data • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Anaptys Announces Late-Breaking Oral Presentation of Complete Phase 2b Data for Rosnilimab in Rheumatoid Arthritis at Upcoming ACR Convergence 2025 (GlobeNewswire)

P2b data • Rheumatoid Arthritis

PHENOTYPING OF HUMAN UC COLONIC TISSUE T CELLS REVEALS INFLAMMATORY PATHWAY GENE EXPRESSION IN PD-1+ CONVENTIONAL AND REGULATORY T CELLS WHICH OVERLAP WITH THOSE REGULATED BY ROSNILIMAB IN A MOUSE MODEL OF COLITIS (UEGW 2025) - P2 | "In UC colonic tissue, PD-1+ CD4 Tcon cells demonstrated increased inflammatory gene expression and PD-1+ Tregs exhibited a pro-inflammatory phenotype, suggesting that targeting both PD-1+ CD4 Tcon and PD-1+ Tregs may contribute to the therapeutic efficacy of rosnilimab in UC. These additional analyses support preclinical findings and suggest beneficial modulation of gene expression pathways of human UC, including reduction of pro-inflammatory cytokines and fibrosis, and upregulation of barrier function genes. These data demonstrate that PD-1 is upstream of multiple clinically validated drivers of UC and support the scientific rationale for studying rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

IO biomarker • Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL20 • IL2RA • IL6 • MMP9 • PD-1 • TBX21

ROSNILIMAB, A DEPLETER AND AGONIST TARGETING PD-1+ T CELLS, DOWNREGULATED AN INFLAMMATORY MYELOID GENE SIGNATURE IN A MURINE MODEL OF COLITIS THAT WAS UPREGULATED IN HUMAN UC COLON TISSUE (UEGW 2025) - P2 | "In addition to reducing pathogenic T cell numbers in this murine model of colitis, rosnilimab treatment also reduced pathogenic macrophages and the inflammatory myeloid gene signature in the colon. These data support previous preclinical findings demonstrating the potential therapeutic benefits of selectively targeting activated PD-1+ T cells and depleting PD-1high T cells in reducing inflammation and improving UC outcomes in a murine model of colitis. These results, together with existing rosnilimab safety data in humans, support the scientific rationale for evaluating rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

Gene Signature • IO biomarker • Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL3 • CD14 • CD80 • CD86 • IL6 • MYD88 • PD-1 • STAT4 • TLR2 • TLR4

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biopharma Co Profile (GlobeNewswire) - "AnaptysBio...announced today that its Board of Directors approved plans to explore separating its business into two independent, publicly traded companies, each poised for strong, sustainable growth.....Upon completion, Biopharma Co will be a clinical-stage biotechnology company focused on the development and potential commercialization of innovative therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033 and ANB101."

Commercial • Immunology • Inflammation

Anaptys Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Rosnilimab (Pathogenic T Cell Depleter):...(i) 424-patient Phase 2b RA trial:...Trial now complete with CDAI LDA responders at Week 28 demonstrating durable responses for at least 12-14 weeks off drug through Week 38....Plan to present complete RA Phase 2b data at a future medical congress...; (ii) Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)....Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025."

P2 data • Trial status • Rheumatoid Arthritis • Ulcerative Colitis

Toward immune tolerance in rheumatoid arthritis: Emerging immunotherapies and targets for long-term remission. (PubMed, Int Immunopharmacol) - "Clinical trials, including Rheumavax and calcitriol liposomes, demonstrate safety and immunomodulatory promise, particularly in early RA. Programmed cell death-1 (PD-1) agonists, like rosnilimab, show potential in restoring immune homeostasis by reducing pathogenic T cell responses...Challenges include patient classification, biomarker detection, and long-term safety. These therapies represent a paradigm shift from broad immunosuppression to targeted immune reprogramming, offering hope for antigen-specific, drug-free remission in RA."

IO biomarker • Journal • Review • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • PD-1

Rosnilimab: "JAK-like efficacy in both 3-month placebo-controlled portion and through 6 months"; Rheumatoid arthritis (AnaptysBio) - Rosnilimab Updated Phase 2b Rheumatoid Arthritis (RA) Data

P2b data • Rheumatoid Arthritis

Synovial Expression Levels of PD-1, the Target of Rosnilimab, Correlate with Disease Activity and Persist Across Disease Stages and Lines of Therapy in Rheumatoid Arthritis (FOCIS 2025) - P2 | "Irrespective of treatment, a correlation of PD-1 and CXCL13 expression with disease activity persisted, suggesting the importance of PD-1 in disease pathogenesis and a rationale for exploring rosnilimab's therapeutic potential. This will be evaluated in the RENOIR study, an ongoing Phase 2 trial of rosnilimab in moderate-to-severe RA patients (NCT06041269)."

Biomarker • IO biomarker • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CXCL13 • TNFA