Quimilza (imsidolimab) / AnaptysBio, Vanda - LARVOL DELTA

Imsidolimab Improves Generalized Pustular Psoriasis (GPP) Pustulation as Measured by the Pustulation Rating Scale (PRS): Results from the GEMINI-1 Study (EADV 2026) - No abstract available

Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Rapid reduction in neutrophils and neutrophil percentage-to-albumin ratio upon treatment with imsidolimab in patients with GPP (EADV 2026) - No abstract available

Clinical

Immunogenicity of Imsidolimab for the Treatment of Generalized Pustular Psoriasis (GPP) (EADV 2026) - No abstract available

Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission (PRNewswire) - "Additionally, the imsidolimab Biologics License Application (BLA) for GPP is currently under review by the FDA with a target action date of December 12, 2026."

Orphan drug • Immunology • Psoriasis • Pustular Psoriasis

Vanda Pharmaceuticals Reports Second Quarter 2026 Financial Results (PRNewswire) - "Quimilza (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026."

PDUFA • Immunology • Psoriasis • Pustular Psoriasis

Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe (PRNewswire) - "This marks the first time the EMA has granted orphan drug designation recognition for a drug to treat GPP in the European Union (EU)."

Orphan drug • Psoriasis

Vanda Pharmaceuticals Inc…announced today that Japan’s Ministry of Health, Labour and Welfare has granted orphan drug designation to imsidolimab for the treatment of generalized pustular psoriasis. (Investing.com)

Orphan drug • Psoriasis

Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. (PubMed, NEJM Evid) - P3 | "Compared with placebo, a significantly higher proportion of patients with GPP randomly assigned to receive a single intravenous dose of imsidolimab were clear or almost clear of the disease after 4 weeks based on the GPPPGA. There were no serious adverse events that led to treatment discontinuation with imsidolimab up to 104 weeks of treatment. (Funded by AnaptysBio; ClinicalTrials.gov number, NCT05352893 for GEMINI-1 and NCT05366855 for GEMINI-2.)."

Clinical • Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

AnaptysBio…announced the completion of its spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business (GlobeNewswire) - "Anaptys will now exclusively manage the financial collaborations for Jemperli with GSK and imsidolimab with Vanda with a focus on protecting and returning the value of its royalties to shareholders....The taxable spin-off was completed today following the distribution to Anaptys shareholders of one share of First Tracks Bio common stock for every one share of Anaptys common stock owned as of the close of business on April 6, 2026, the record date for the distribution."

Commercial • dMMR • MSI-H • Endometrial Cancer • Psoriasis

The IL-36 Cytokine Rheostat: Hierarchical Regulation of Epithelial-Immune Crosstalk and Precision Therapy in Psoriatic and Related Dermatoses. (PubMed, Clin Cosmet Investig Dermatol) - "The successful clinical translation of IL-36R blockade-exemplified by spesolimab and imsidolimab-validates IL-36 as a tractable therapeutic target and underscores its role within the IL-17A/TNF-α/IL-23 cytokine network. Collectively, these advances position IL-36 as a cytokine rheostat capable of scaling immune intensity according to molecular and spatial context. Emerging multi-omic and spatial transcriptomic analyses are now redefining IL-36-high endotypes across inflammatory diseases, suggesting that IL-36 may serve as a reference axis for precision immunotherapy and as a conceptual model for hierarchical immune calibration in chronic inflammation."

Journal • Review • Dermatology • Fibrosis • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Pustular Psoriasis • Rheumatology • Seronegative Spondyloarthropathies • CD123 • IL17A • IL1RAP • IL23A • TNFA

Efficacy and Safety of IL-36 inhibitors in Generalized Pustular Psoriasis: A Systematic Review and Single-arm Meta-Analysis (AAD 2026) - "Anti–IL-36 agents rapidly improve GPP, with early, sustained efficacy and manageable safety, highlighting IL-36 blockade as a promising therapeutic strategy."

Retrospective data • Review • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Anaptys Announces $100 Million Stock Repurchase Plan and Provides a Business Update (GlobeNewswire) - "Following the planned spin-off of First Tracks Biotherapeutics...on April 20, 2026, Anaptys will manage the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their value to shareholders. The company will operate with limited FTEs, minimal operating expenses and an initial ~$140-$145 million in net cash and investments...Anticipate paydown of remaining non-recourse debt monetization to Sagard by the end of Q2 2027"

Commercial • dMMR • MSI-H • Endometrial Cancer • Microsatellite Instability • Psoriasis

Vanda Pharmaceuticals…announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026 (PRNewswire) - "In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin (GPPPGA 0/1) at Week 4 compared to 13% on placebo."

FDA filing • PDUFA • Pustular Psoriasis

Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis (PRNewswire) - "The BLA is supported by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies....If granted, priority review would establish a six-month review cycle, with a potential FDA approval of imsidolimab for the treatment of GPP as early as mid-2026."

FDA approval • FDA filing • Pustular Psoriasis

Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in the fourth quarter of 2025 (PRNewswire)

FDA filing • Psoriasis

Anaptys Announces Intent to Separate Biopharma Operations from Substantial Royalty Assets by Year-end 2026 (GlobeNewswire) - "Upon completion, Royalty Management Co will hold and continue to manage the rights to the potential...imsidolimab milestones and royalties from Vanda with a focus on protecting and returning value of the royalties to its shareholders....For imsidolimab, under the financial collaboration with Vanda, Royalty Management Co would be eligible to receive up to $35 million for future sales milestones and regulatory approvals, including a $5 million milestone upon U.S. FDA approval, in addition to a 10% royalty on net sales. Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025."

Commercial • FDA filing • Psoriasis

Imsidolimab, a novel high affinity IgG4 IL-36 Receptor Antagonist, was Effective and Well-Tolerated in Patients with Generalized Pustular Psoriasis: Results from Phase 3 trials, GEMINI-1 and GEMINI-2 (EADV 2025) - "In contrast, 23 cases of ADAs (23/60, 46%) were reported among patients who had received at least one dose of spesolimab. Single IV imsidolimab doses (300mg and 750mg) and monthly SC doses (200mg) demonstrated clinically meaningful results for the treatment of GPP flares. Across both GEMINI-1 and GEMINI-2, imsidolimab was proven to be safe and well tolerated. Targeting IL-36 signaling with imsidolimab represents a promising therapeutic option for GPP patients."

Clinical • P3 data • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • CD123

ANB019-207: A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Vanda Pharmaceuticals | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Oncology

Imsidolimab a novel high affinity IgG4 IL36 Receptor Antagonist was Effective and Well Tolerated in Patients with GPP (ESDR 2025) - "In contrast, a total of 23 cases of ADAs (23/50, 46%) were reported among patients who had received at least one dose of spesolimab. Imsidolimab has demonstrated effectiveness in GPP with a well-tolerated and safe profile after a single dose. Targeting IL36 signaling with imsidolimab represents a promising therapeutic option for GPP patients."

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • CD123

Imsidolimab, a novel IgG4 IL36 receptor antagonist, was effective and well tolerated in patients with GPP (SID 2025) - "In contrast, a total of 23 cases of ADAs (23/50, 46%) were reported among patients who had received at least 1 dose of spesolimab. Imsidolimab has demonstrated effectiveness in GPP with a well tolerated and safe profile after a single dose. Targeting IL36 signaling with imsidolimab represents a promising therapeutic option."

Clinical • Late-breaking abstract • Dermatology • Immunology • Pain • Psoriasis • Pustular Psoriasis

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "PONVORY (ponesimod): Investigational New Drug (IND) applications for PONVORY in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024....Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025.....Imsidolimab: Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025."

EMA filing • FDA filing • IND • Immunology • Psoriasis • Ulcerative Colitis

Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist (PRNewswire) - "Vanda Pharmaceuticals Inc...today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb)...In 2025, Vanda intends to initiate and complete the technology transfer activities and will immediately begin preparing the BLA and MAA applications for the US and EU and making preparations for commercialization...Under the terms of the agreement, Vanda will make to Anaptys an upfront payment of $10 million and a $5 million payment for existing drug supply. Anaptys is also eligible to receive up to $35 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales. Vanda will receive an exclusive global license to develop, manufacture and commercialize imsidolimab."

Licensing / partnership • Psoriasis

Imsidolimab, an IL-36 Receptor Antagonist, was Effective and Well Tolerated for Treatment and Prevention of Flares in Patients with Generalized Pustular Psoriasis: Results from the Phase 3 Trials, GEMINI-1 and GEMINI-2 (EADV 2024) - P3 | "Single IV doses of imsidolimab 300mg and 750mg demonstrated clinically meaningful results and were well tolerated in patients with GPP flares. Maintenance dosing with monthly SC imsidolimab for at least 24 wks was also well tolerated, maintained GPPPGA 0/1 responses and prevented GPP flares. Targeting IL-36 signaling with imisdolimab represents a promising therapeutic option for GPP patients."

Clinical • P3 data • Complement-mediated Rare Disorders • Dermatology • Eosinophilia • Immunology • Infectious Disease • Psoriasis • Pustular Psoriasis

Imsidolimab, an IL-36 receptor antagonist, was effective and well tolerated for treatment and prevention of flares in patients with generalized pustular psoriasis: results from the phase 3 trials, GEMINI-1 and GEMINI-2 (EADV 2024) - P3 | "Single IV doses of imsidolimab 300mg and 750mg demonstrated clinically meaningful results and were well tolerated in patients with GPP flares. Maintenance dosing with monthly SC imsidolimab for at least 24 wks was also well tolerated, maintained GPPPGA 0/1 responses and prevented GPP flares. Targeting IL-36 signaling with imisdolimab represents a promising therapeutic option for GPP patients."

Clinical • P3 data • Complement-mediated Rare Disorders • Dermatology • Eosinophilia • Immunology • Infectious Disease • Psoriasis • Pustular Psoriasis

GEMINI2: Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (clinicaltrials.gov) - P3 | N=42 | Terminated | Sponsor: AnaptysBio, Inc. | Trial completion date: Dec 2026 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Feb 2024; AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest patient having been treated through 92 weeks

Trial completion date • Trial primary completion date • Trial termination • Dermatology • Immunology • Psoriasis • Pustular Psoriasis