rezpegaldesleukin (NKTR-358) / Nektar Therapeutics - LARVOL DELTA

Multi-omic profiling identifies early molecular responses to rezpegaldesleukin, a novel regulatory T cell-inducing therapy, in atopic dermatitis (EADV 2026) - No abstract available

Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Rezpegaldesleukin, a Novel Regulatory T Cell-Inducing Biologic, Demonstrates Efficacy and Safety in Severe-to-Very-Severe Alopecia Areata: 52-Week Results from the Phase 2b REZOLVE-AA Study (EADV 2026) - No abstract available

Clinical • P2b data • Alopecia • Immunology

Rezpegaldesleukin Provides Durable and Deepening Improvements in the Signs and Symptoms of Atopic Dermatitis with Monthly and Quarterly Dosing: Results from the Phase 2b REZOLVE-AD Maintenance Part of Study (EADV 2026) - No abstract available

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (clinicaltrials.gov) - P2 | N=94 | Completed | Sponsor: Nektar Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Nektar Announces Publication in The Lancet of Positive Phase 2b REZOLVE-AD 16-Week Induction Results of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "Patients treated with rezpegaldesleukin showed statistically significant, dose-dependent improvement in mean percent reduction in EASI from baseline at Week 16: 61%, 58%, and 53% for the 24 μg/kg q2w, 18 μg/kg q2w, and 24 μg/kg q4w arms, respectively, compared with 31% for placebo (p<0.0001, p<0.0001, and p=0.0002, respectively)....Significant improvements over placebo were observed in EASI-75 (42% vs. 17%), EASI-90 (25% vs. 9%), Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1 response (20% vs. 8%), Itch Numerical Rating Scale (NRS) 4-point reduction (42% vs. 16%), and body surface area (BSA) change from baseline (-54% vs. -17%), all favoring rezpegaldesleukin 24 μg/kg q2w."

P2b data • Atopic Dermatitis

Rezpegaldesleukin treatment of moderate-to-severe atopic dermatitis (REZOLVE-AD): final results from the 16-week induction period of an international, double-blind, placebo-controlled, randomised phase 2b study. (PubMed, Lancet) - P2 | "Over the 16-week induction period, rezpegaldesleukin treatment resulted in significant and clinically meaningful improvements across multiple clinical endpoints, including the primary endpoint of EASI percentage change from baseline, in comparison with placebo. Rezpegaldesleukin had a clinically favourable adverse event profile in adult patients with moderate-to-severe atopic dermatitis, supporting its further development as a novel Treg-enhancing biological treatment."

Journal • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilia • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Pain • Respiratory Diseases

Nektar Therapeutics Announces Second Quarter 2026 Financial Results (PRNewswire) - "'We initiated the first Phase 3 ZENITH AD trials in atopic dermatitis in July, and we plan to start a single registrational Phase 3 study in alopecia areata in early 2027. Our Phase 3 program establishes a clear path to the first BLA submission for rezpegaldesleukin in 2029'."

FDA filing • New P3 trial • Trial status • Alopecia • Atopic Dermatitis

Upcoming Data Presentations at the 2026 European Academy of Dermatology and Venereology Congress (PRNewswire) - "(i) Oral Presentation: 'Rezpegaldesleukin Provides Durable and Deepening Improvements in the Signs and Symptoms of Atopic Dermatitis with Monthly and Quarterly Dosing: Results from the Phase 2b REZOLVE-AD Maintenance Part of Study'; Abstract No: AS-1732...; (ii) Oral Presentation: 'Rezpegaldesleukin, a Novel Regulatory T Cell-Inducing Biologic, Demonstrates Efficacy and Safety in Severe-to-Very-Severe Alopecia Areata: 52-Week Results from the Phase 2b REZOLVE-AA Study'; Abstract No: AS-1872..."

P2b data • Alopecia • Atopic Dermatitis

Nektar Therapeutics…announced the initiation of the first two global registrational trials (ZENITH AD-1 and ZENITH AD-2) in the Phase 3 ZENITH AD program for rezpegaldesleukin. (PRNewswire) - "The ZENITH AD program is evaluating rezpegaldesleukin in patients who are 12 years of age or older with moderate-to-severe atopic dermatitis. The program includes three global, randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment-naive patients and ZENITH AD-3 will enroll patients with prior systemic biologic and/or JAK inhibitor treatment experience...we expect initial data from ZENITH AD in mid-2028. Separately, in early 2027, we plan to initiate a single registrational Phase 3 trial in alopecia areata...we also look forward to the initial data from the Phase 2 study of rezpegaldesleukin in Type 1 diabetes in 2027."

New P3 trial • P2 data • P3 data • Alopecia • Atopic Dermatitis • Immunology • Type 1 Diabetes Mellitus

ZENITH AD-2: A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ? 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=510 | Recruiting | Sponsor: Nektar Therapeutics

Monotherapy • New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ZENITH AD-1: A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ? 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=510 | Recruiting | Sponsor: Nektar Therapeutics

Monotherapy • New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Alopecia Areata and Atopic Dermatitis: Common Mechanisms and Emerging Therapeutics. (PubMed, J Inflamm Res) - "JAK inhibitors-including baricitinib, ritlecitinib, upadacitinib, and abrocitinib-have demonstrated efficacy in AA and/or AD by interrupting cytokine signaling central to both diseases. Dupilumab, an interleukin -4 receptor alpha antagonist FDA-approved for AD, has demonstrated benefit in a specific subset of AA patients with concurrent atopic disease; these findings highlight pathophysiologic heterogeneity within the disease and support the need for endotype-stratified treatment strategies. Investigational therapies targeting the OX40/OX40 ligand costimulatory pathway, interleukin 2 receptor agonists (rezpegaldesleukin), interleukin 7 receptor antagonists (bempikibart), and tri-specific cytokine inhibitors (EQ101) represent the next generation of agents that may treat both conditions by restoring immune homeostasis rather than broadly suppressing immunity. In this narrative review, we synthesize current understanding of the shared immunopathogenesis of AA and AD and..."

IO biomarker • Journal • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IFNG • IL13 • IL15 • IL4 • IL7 • IL7R

52-Week Topline Results from 16-Week Blinded Treatment Extension of REZOLVE-AA Demonstrate Deepening of Responses in Severe-to-Very-Severe Alopecia Areata with Rezpegaldesleukin (Nektar Therapeutics Press Release) - "At week 52 for overall study population, patients who achieved SALT Score ≤20 were 25.8% in low dose rezpegaldesleukin arm (versus 14.8% at week 36) and 27.6% in high dose rezpegaldesleukin arm (versus 15.6% at week 36) as compared to 6.7% with placebo (versus 6.7% at week 36) with a p-value of 0.049...At week 52 for overall study population1, patients who achieved SALT Score ≤30 were 30.2% in low dose rezpegaldesleukin arm (versus 21.9% at week 36) and 35.0% in high dose rezpegaldesleukin arm (versus 29.0% at week 36) as compared to 8.4% with placebo (versus 8.4% at week 36)...Nektar plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026."

P2b data • Alopecia • Immunology

Nektar to Hold Conference Call to Discuss 52-Week Topline Results from the 16-Week Extension Treatment Period for its REZOLVE-AA Phase 2b Study of Rezpegaldesleukin in Alopecia Areata on April 20, 2026 (Yahoo Finance)

P2b data • Alopecia • Immunology

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not yet recruiting ➔ Recruiting | Trial completion date: May 2029 ➔ May 2028 | Initiation date: Nov 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial initiation date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy and Safety Results Following 36-Weeks of Therapy in Severe-to-Very-Severe Alopecia Areata (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P2b data • Alopecia • Immunology

Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy, Safety, and Baseline Severity–Dependent Treatment Response in Moderate-to-Severe Atopic Dermatitis (AAD 2026) - P2 | "Rezpegaldesleukin demonstrated statistically significant improvement in AD severity over the 16-week induction period. These results support further development of rezpegaldesleukin as a novel biologic AD treatment."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL2

At AAD 2026, Dr. David Rosmarin presented a late-breaking research oral presentation highlighting previously-released data titled: "Novel Regulatory T-cell Enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy and Safety Results Following 36-Weeks of Therapy in Severe-to-Very-Severe Alopecia Areata" (PRNewswire) - "On the primary endpoint of mean Severity of Alopecia Tool (SALT) reduction at 36 weeks of treatment, high dose rezpegaldesleukin, 24 µg/kg every two weeks (q2w), demonstrated a mean reduction in the SALT score of 28.2% in the 24 µg/kg arm versus 11.2% in the placebo arm. Mean percent reduction in SALT scores at 36 weeks was 30% for both treatment arms versus 6% in the placebo arm, achieving statistical significance (p<0.05) when excluding four patients that did not meet major study eligibility criteria at baseline. Rezpegaldesleukin was well tolerated and its safety profile was consistent with previously reported results."

P2b data • Alopecia

At AAD 2026, data from the global Phase 2b REZOLVE-AD study in 393 patients with moderate-to-severe atopic dermatitis… (PRNewswire) - "As presented at AAD, patients in the Phase 2b REZOLVE-AD study demonstrated consistent reduction in mean Eczema Area and Severity Index (EASI) scores over the 16-week induction period as compared to placebo regardless of baseline disease severity as measured by baseline vIGA-AD scores of 3 or 4. During the 16-week induction period, patients also achieved comparable EASI-75 (at least a 75% improvement in EASI score from baseline) and EASI-90 response (at least a 90% improvement in EASI score from baseline). These disease improvement metrics were also comparable by geographic region....Based upon results from the Phase 2b REZOLVE-AD study of rezpegaldesleukin, Nektar is planning to initiate the Phase 3 ZENITH-AD program of rezpegaldesleukin in moderate-to-severe atopic dermatitis patients in the second quarter of 2026."

New P3 trial • P2b data • Atopic Dermatitis

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents. (PubMed, Cureus) - "This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures.  A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Data from Phase 2b Studies for Rezpegaldesleukin Accepted for Two Oral Presentations at the 2026 American Academy of Dermatology Annual Meeting (PRNewswire)

P2b data • Alopecia • Atopic Dermatitis

Dupilumab Outperforms Approved and Investigational Biologic Monotherapies in Moderate-to-Severe Atopic Dermatitis (AAD 2026) - " Seventeen RCTs (n=5508) compared dupilumab, tralokinumab, lebrikizumab, rocatinlimab, amlitelimab and rezpegaldesleukin with placebo at week 16 (rocatinlimab 300mg, 24 weeks). Dupilumab 300mg was the most effective biologic for moderate-to-severe AD, achieving both the strongest relative efficacy and the highest SUCRA ranking. Lebrikizumab emerged as a close second, particularly for itch improvement."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Upcoming Milestones (PRNewswire) - "(i) Data from the 36-week treatment period of the REZOLVE-AA study in patients with alopecia areata were accepted for a presentation in a late-breaking oral session at the...AAD 2026 Annual Meeting...; (ii) Topline data to be reported from the blinded 16-week treatment extension period in the Phase 2b REZOLVE-AA study of rezpegaldesleukin in alopecia areata in April 2026; (iii) Commencement of the Phase 3 studies for rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in Q2 2026; (iv) Presentation of 36-week maintenance data from the Phase 2b REZOLVE-AD study of rezpegaldesleukin in moderate-to-severe atopic dermatitis at a medical conference in second half of 2026; (v) Topline data to be reported from the 24-week off-treatment period in REZOLVE-AA in Q4 2026; (vi) Topline data to be reported from the 52-week off-treatment period in REZOLVE-AD in Q1 2027."

Late-breaking abstract • New P3 trial • P2b data • Alopecia • Atopic Dermatitis

Nektar Therapeutics…announced the pricing of its upsized underwritten public offering of $400 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants. (PRNewswire) - "Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development (including Phase 3 trials for rezpegaldesleukin) and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes."

Financing • Alopecia • Atopic Dermatitis • Type 1 Diabetes Mellitus

New REZOLVE-AD Maintenance Data in Atopic Dermatitis Demonstrate Rezpegaldesleukin Resulted in Durable and New Responses Across Key Disease Measurements with Both Monthly and Quarterly Dosing (PRNewswire) - "71% and 83% of patients maintained EASI-75 responses and 85% and 63% maintained vIGA-AD 0/1 responses with 24 µg/kg monthly and quarterly dosing, respectively. Meaningful improvement in responses observed across key efficacy endpoints at week 52 with both monthly and quarterly dosing, including an up to 5-fold increase in EASI-100 response rates. Favorable safety profile consistent with previously reported results for rezpegaldesleukin. Durability of maintained response rates supports advancement to pivotal Phase 3 program evaluating both monthly and quarterly maintenance dosing....'We look forward to advancing to Phase 3 studies quickly with the goal of submitting a BLA in 2029."

Filing • P2b data • Atopic Dermatitis